Central Nervous System InfectionsNCT06358209
Safety and Efficacy of Ventricular Irrigation for Ventriculitis
A study testing Ventricular irrigation in people with Central Nervous System Infections, run by RenJi Hospital at 35 sites in China.
Trial summary
Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Currently, the treatment for ventriculitis is challenging, with poor prognosis. The mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Central Nervous System Infections
- What is being tested?
- Ventricular irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 35 sitesChina
- Study dates
- 1 Jul 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years old;
- CSF is purulent (it appears cloudy or yellow) and white blood cell count over 1000×10^6/L.
- Fever (>38.0°C)
- Meet at least one of the following: 1. Patient has organism(s) identified from CSF by a culture or non-culture based microbiologic testing method; 2. Cranial CT or MRI indicating intraventricular floccule or pus.
- With consent form
Who cannot join
- With GCS score of 3
- With unstable vital signs such as no spontaneous breathing and blood pressure maintenance drugs
- With severe propensity for bleeding (Such as coagulation dysfunction, active bleeding, etc.), and unable to tolerate the surgical procedures or operations related to ventricular irrigation treatment.
- Pregnant or lactating women
Trial locations and contacts
35 sites in 1 country. Contact the study team or a site near you to ask about taking part.
35 sites in 1 country
China35 sites, 35 recruiting
- Not yet recruiting
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality
Rongcai Jiang, Dr
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Jinfang Liu, Dr
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Chaohua Yang, Dr
- Not yet recruiting
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
Wenhua Fang, Dr
- Not yet recruiting
Ganzhou People's Hospital
Ganzhou, Jiangxi
Qiuhua Jiang, Dr
- Not yet recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong
Binghui Qiu, Dr
- Not yet recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong
Qinghua Wang, Dr
- Not yet recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang
Xiaofeng Yang, Dr
- Not yet recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Hongsheng Liang, Dr
- Not yet recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui
Xiangpin Wei, Dr
- Not yet recruiting
The Second People's Hospital of Anhui Province
Hefei, Anhui
Yongming Zhang, Dr
- Not yet recruiting
Inner Mongolia People's Hospital
Hohhot, The Nei Monggol Autonomous Region
Weiping Zhao, Dr
- Recruiting
South taihu hospital affiliated to huzhou college
Huzhou, Zhejiang
Liansheng Long, Dr
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Qibing Huang, Dr
- Not yet recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Yan Zhang, Dr
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Jing Ji, Dr
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu
Chunhua Hang, Dr
- Not yet recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Jinlong Shi, Dr
- Not yet recruiting
The affiliated people's hospital of ningbo university
Ningbo, Zhejiang
Feng Gao, Dr
- Recruiting
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Jiyao Jiang, Dr, 021-68383729, jiyaojiang@126.com
Junfeng Feng, Dr, 13611860825, fengjfmail@163.com
- Recruiting
Shanghai Donglei Brain Hospital
Shanghai, Shanghai Municipality
Liang Gao, Dr
- Not yet recruiting
Shanghai East Hospital
Shanghai, Shanghai Municipality
Chunlong Zhong, Dr
- Not yet recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality
Xianzhen Chen, Dr
- Not yet recruiting
The Second Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality
Lijun Hou, Dr
- Not yet recruiting
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning
Yijun Bao, Dr
- Not yet recruiting
Shenzhen Second People's Hospital
Shenzhen, Guangdong
Xianjian Huang, Dr
- Not yet recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Xiaoou Sun, Dr
- Not yet recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region
Yongxin Wang, Dr
- Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei
Kai Shu, Dr
- Not yet recruiting
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui
Xuefei Shao, Dr
- Not yet recruiting
904 Hospital of the People's Liberation Army Joint Logistic Support Force
Wuxi, Jiangsu
Yuhai Wang, Dr
- Not yet recruiting
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi
Yan Qu, Dr
- Not yet recruiting
Affiliated Hospital of Yangzhou University
Yangzhou, Jiangsu
Aijun Peng, Dr
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
Guang Feng, Dr
- Not yet recruiting
Zhongshan Hospital of Traditional Chinese Medicine
Zhongshan, Guangdong
Dan Jin, Dr
About this study
Official title: Safety and Efficacy of Ventricular Irrigation for Ventriculitis: a Randomized Controlled Trial
Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Currently, the treatment for ventriculitis is challenging, with poor prognosis. The mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy.
Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. High-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.
This multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with ventriculitis.
Read the detailed description
Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Ventriculitis is associated not only with community-acquired diseases but also, more importantly, with invasive clinical procedures, including craniotomy, external ventricular drainage (EVD), lumbar cistern drainage, V-P shunt, and deep brain stimulation, among others. Depending on the diagnostic criteria, the incidence of post-neurosurgery ventriculitis ranges from approximately 5% to 20%, with risk factors including age, prolonged placement of EVD, and intracranial hemorrhage. Besides, the pathogens leading to ventricular infection are also diverse, with the main pathogens including coagulase-negative Staphylococci, Staphylococcus aureus, Propionibacterium acnes, and Gram-negative bacilli.
The treatment for ventriculitis is challenging, with poor prognosis. Under currently widely adopted treatment strategies, the mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy. This imposes significant burden on families and society. Therefore, how to further improve prognosis of ventriculitis, and reduce the mortality and disability rates, remains to be addressed.
Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. As an infectious disease, surgical procedures such as irrigation and drainage have the potential to play a role in reducing infection and improving prognosis for ventriculitis.
In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques (including endoscopic ventricular irrigation and dual catheter irrigation techniques) via replacing saline and draining purulent cerebrospinal fluid (CSF), may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. A prospective controlled study that included 33 patients with ventriculitis divided participants into groups receiving ventricular irrigation treatment and conventional treatment. The study results showed that compared to conventional treatment, ventricular irrigation resulted in higher mRS prognosis scores, shorter hospital stays, and the study also showed a trend towards reduced mortality in irrigation group. However, this study was limited by a small sample size, limited study endpoints and not strictly randomized. Currently, high-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.
Based on these considerations, this multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with ventriculitis.
- Conditions
- Central Nervous System Infections
- Being tested
- Ventricular irrigation
- Keywords
- Ventriculitis, Ventricular irrigation
- Medical subject headings
- Central Nervous System Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ventricular irrigationProcedure or surgery
Catheter ventricular irrigation can be employed by various forms. Lavage is performed with with each time at least 200ml of saline. Aside from lavage sessions, the lavage is paused, but continuous CSF drainage remains open.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Conventional treatments for ventriculitis, including: external ventricular drainage or lumbar cistern drainage for continuous drainage, systemic and intrathecal antibiotics along with other supportive care. The treatment plan, including the type, dosage, and duration of antibiotics, follows guidelines "2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis" and "Chinese Expert Consensus on Diagnosis and Treatment of Central Nervous System Infections in Neurosurgery (2021 Edition)". |
| Ventricular irrigation group | Experimental | Intervention group employs catheter ventricular irrigation with various forms. Lavage is performed with each time at least 200ml of normal saline, and irrigation treatment over 7 days. Additional treatments, including the administration of antibiotics, are consistent with those in the control group. Receives: Procedure: Ventricular irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate
Clinical cure rate at 4 weeks after enrollment and randomization
Measured: 4 weeks after enrollment
Secondary outcomes (6)
GOSE
Extended Glasgow Outcome Scale at discharge and within 6 months after diagnosis of ventriculitis
Measured: up 6 months after enrollment and randomization
Microbial clearance rate
Microbial clearance rate at 4 weeks after enrollment and randomization
Measured: 4 weeks after enrollment
CSF test results
Results of CSF test at 8th day after enrollment, and within 1 week before discharge, including CSF glucose, CSF protein, CSF WBC count and organism(s) identification by a culture or non-culture based microbiologic testing method
Measured: At 8th day after enrollment, and within 1 week before discharge
Cranial CT or MRI indicating
Cranial CT or MRI indicating at 8th day after enrollment, and within 1 week before discharge
Measured: At 8th day after enrollment, and within 1 week before discharge
Length of ICU stay and hospital stay
Length of ICU stay and hospital stay
Measured: up to 6 months after enrollment and randomization
Complications
Blood from puncture canal and intracranial during hospitalization
Measured: up to 6 months after enrollment and randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jul 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System InfectionsStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Southern Medical University, China, First Affiliated Hospital of Zhejiang University, 904th Hospital of the Joint Logistics Support Force of the PLA, Shenzhen Second People's Hospital, Shanghai East Hospital, Xuanwu Hospital, Beijing, South Taihu Hospital Affiliated to Huzhou College, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital with Nanjing Medical University, Yangzhou University, The First Affiliated Hospital of Soochow University, Zhongshan Hospital Of Traditional Chinese Medicine, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Xinjiang Medical University, West China Hospital, The Second Affiliated Hospital of Air Force Military Medical University, Qilu Hospital of Shandong University, The Fourth Affiliated Hospital of China Medical University, Ganzhou City People's Hospital, Xiangya Hospital of Central South University, Tongji Hospital, First Affiliated Hospital of Harbin Medical University, Henan Provincial People's Hospital, The Second People's Hospital of Anhui Province, The First Affiliated Hospital of University of Science and Technology of China, First Affiliated Hospital of Fujian Medical University, Shanghai Donglei Brain Hospital, The Affiliated People's Hospital of Ningbo University, Inner Mongolia People's Hospital, Second Affiliated Hospital of Nanchang University, Affiliated Hospital of Nantong University, First Affiliated Hospital of Wannan Medical College, The Second Affiliated Hospital of Naval Medical University, Shanghai 10th People's Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, The First People's Hospital of Zhangjiagang City, Suzhou Municipal Hospital, Liaocheng People's Hospital, Jining First People's Hospital, Qilu Hospital of Shandong University (Qingdao), Weifang People's Hospital（The First Affiliated Hospital of Shandong Second Medical University）, Dezhou Hospital Qilu Hospital of Shandong University, Second Affiliated Hospital of Wenzhou Medical University, The Affiliated Hospital of Xuzhou Medical University, Hainan General Hospital, Southwest Hospital （The First Hospital Affiliated to AMU）, The Peoples' Hospital of Jiaozuo City, Kaifeng Central Hospital, Henan Province, P.R. China, Zhumadian Center Hospital, Zhoukou Central Hospital, Zhengzhou Center Hospital Affiliated to Zhengzhou University, Anyang People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Third Affiliated Hospital of Henan Medical University, Nanyang Central Hosptial, Xuchang Central Hospital, Sanmenxia Central Hospital, The Second Hospital & Clinical Medical School, Lanzhou University, General Hospital of Ningxia Medical University
- Responsible party
- Sponsor
- Investigators
- Jiyao Jiang, Dr, Principal investigator, Renji Hospital, School of Medicine, Shanghai Jiaotong UniversityJunfeng Feng, Dr, Study director, Renji Hospital, School of Medicine, Shanghai Jiaotong UniversityQinghua Wang, Dr, Study director, Southern Medical University, ChinaXiaofeng Yang, Dr, Study director, First Affiliated Hospital of Zhejiang UniversityYuhai Wang, Dr, Study director, 904th Hospital of the Joint Logistics Support Force of the PLAXianjian Huang, Dr, Study director, Shenzhen Second People's HospitalXuefei Shao, Dr, Study director, First Affiliated Hospital of Wannan Medical CollegeLijun Hou, Dr, Study director, The Second Affiliated Hospital of Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06358209
- Sponsor's protocol ID
- LY2024-045-B
- Status last verified
- Sep 2026
- First submitted
- 31 Mar 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary. A Data Access Agreement is required, and all access must comply with regulatory restrictions imposed on the original study.
Publications
Tunkel AR, Hasbun R, Bhimraj A, Byers K, Kaplan SL, Scheld WM, van de Beek D, Bleck TP, Garton HJL, Zunt JR. 2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis. Clin Infect Dis. 2017 Mar 15;64(6):e34-e65. doi: 10.1093/cid/ciw861.
PubMed 28203777Al Menabbawy A, El Refaee E, Soliman MAR, Elborady MA, Katri MA, Fleck S, Schroeder HWS, Zohdi A. Outcome improvement in cerebral ventriculitis after ventricular irrigation: a prospective controlled study. J Neurosurg Pediatr. 2020 Sep 4;26(6):682-690. doi: 10.3171/2020.5.PEDS2063. Print 2020 Dec 1.
PubMed 32886918Hasbun R. Healthcare-associated ventriculitis: current and emerging diagnostic and treatment strategies. Expert Rev Anti Infect Ther. 2021 Aug;19(8):993-999. doi: 10.1080/14787210.2021.1866544. Epub 2020 Dec 24.
PubMed 33334204Humphreys H, Jenks PJ. Surveillance and management of ventriculitis following neurosurgery. J Hosp Infect. 2015 Apr;89(4):281-6. doi: 10.1016/j.jhin.2014.12.019. Epub 2015 Jan 29.
PubMed 25687249Rogers T, Sok K, Erickson T, Aguilera E, Wootton SH, Murray KO, Hasbun R. Impact of Antibiotic Therapy in the Microbiological Yield of Healthcare-Associated Ventriculitis and Meningitis. Open Forum Infect Dis. 2019 Feb 6;6(3):ofz050. doi: 10.1093/ofid/ofz050. eCollection 2019 Mar.
PubMed 30899767Karvouniaris M, Brotis A, Tsiakos K, Palli E, Koulenti D. Current Perspectives on the Diagnosis and Management of Healthcare-Associated Ventriculitis and Meningitis. Infect Drug Resist. 2022 Feb 28;15:697-721. doi: 10.2147/IDR.S326456. eCollection 2022.
PubMed 35250284Karvouniaris M, Brotis AG, Tsiamalou P, Fountas KN. The Role of Intraventricular Antibiotics in the Treatment of Nosocomial Ventriculitis/Meningitis from Gram-Negative Pathogens: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Dec;120:e637-e650. doi: 10.1016/j.wneu.2018.08.138. Epub 2018 Aug 29.
PubMed 30172065Luque-Paz D, Revest M, Eugene F, Boukthir S, Dejoies L, Tattevin P, Le Reste PJ. Ventriculitis: A Severe Complication of Central Nervous System Infections. Open Forum Infect Dis. 2021 Apr 29;8(6):ofab216. doi: 10.1093/ofid/ofab216. eCollection 2021 Jun.
PubMed 34095339Chan AK, Birk HS, Yue JK, Winkler EA, McDermott MW. Bilateral External Ventricular Drain Placement and Intraventricular Irrigation Combined with Concomitant Serial Prone Patient Positioning: A Novel Treatment for Gravity-Dependent Layering in Bacterial Ventriculitis. Cureus. 2017 Apr 18;9(4):e1175. doi: 10.7759/cureus.1175.
PubMed 28533993Terada Y, Mineharu Y, Arakawa Y, Funaki T, Tanji M, Miyamoto S. Effectiveness of neuroendoscopic ventricular irrigation for ventriculitis. Clin Neurol Neurosurg. 2016 Jul;146:147-51. doi: 10.1016/j.clineuro.2016.05.010. Epub 2016 May 9.
PubMed 27219537Gaderer C, Schaumann A, Schulz M, Thomale UW. Neuroendoscopic lavage for the treatment of CSF infection with hydrocephalus in children. Childs Nerv Syst. 2018 Oct;34(10):1893-1903. doi: 10.1007/s00381-018-3894-7. Epub 2018 Jul 11.
PubMed 29995267Qin G, Liang Y, Xu K, Xu P, Ye J, Tang X, Lan S. Neuroendoscopic lavage for ventriculitis: Case report and literature review. Neurochirurgie. 2020 Apr;66(2):127-132. doi: 10.1016/j.neuchi.2019.12.005. Epub 2020 Feb 19.
PubMed 32087178Stati G, Migliorino E, Moneti M, Castioni CA, Scibilia A, Palandri G, Virgili G, Aspide R. Treatment of cerebral ventriculitis with a new self-irrigating catheter system: narrative review and case series. J Anesth Analg Crit Care. 2023 Nov 8;3(1):46. doi: 10.1186/s44158-023-00131-5.
PubMed 37941074de Sousa Carvalho Dezena JE, Gerbelli CLB, Braga TKK, Ballestero MFM. How I do it: brainwashing for purulent ventriculitis. Acta Neurochir (Wien). 2023 Nov;165(11):3267-3269. doi: 10.1007/s00701-023-05607-5. Epub 2023 May 20.
PubMed 37209145Tomita Y, Shimazu Y, Kawakami M, Matsumoto H, Fujii K, Kameda M, Yasuhara T, Suruga Y, Ota T, Kimata Y, Kurozumi K, Date I. Pyogenic Ventriculitis After Anterior Skull Base Surgery Treated With Endoscopic Ventricular Irrigation And Reconstruction Using a Vascularized Flap. Acta Med Okayama. 2021 Apr;75(2):243-248. doi: 10.18926/AMO/61908.
PubMed 33953433
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Ventricular Irrigation for Ventriculitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06358209
- Acronym / sponsor ID
- LY2024-045-B
- Conditions
- Central Nervous System Infections
- Keywords
- Ventriculitis, Ventricular irrigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Southern Medical University, China, First Affiliated Hospital of Zhejiang University, 904th Hospital of the Joint Logistics Support Force of the PLA, Shenzhen Second People's Hospital, Shanghai East Hospital, Xuanwu Hospital, Beijing, South Taihu Hospital Affiliated to Huzhou College, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital with Nanjing Medical University, Yangzhou University, The First Affiliated Hospital of Soochow University, Zhongshan Hospital Of Traditional Chinese Medicine, Nanfang Hospital, Southern Medical University, First Affiliated Hospital of Xinjiang Medical University, West China Hospital, The Second Affiliated Hospital of Air Force Military Medical University, Qilu Hospital of Shandong University, The Fourth Affiliated Hospital of China Medical University, Ganzhou City People's Hospital, Xiangya Hospital of Central South University, Tongji Hospital, First Affiliated Hospital of Harbin Medical University, Henan Provincial People's Hospital, The Second People's Hospital of Anhui Province, The First Affiliated Hospital of University of Science and Technology of China, First Affiliated Hospital of Fujian Medical University, Shanghai Donglei Brain Hospital, The Affiliated People's Hospital of Ningbo University, Inner Mongolia People's Hospital, Second Affiliated Hospital of Nanchang University, Affiliated Hospital of Nantong University, First Affiliated Hospital of Wannan Medical College, The Second Affiliated Hospital of Naval Medical University, Shanghai 10th People's Hospital, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, The First People's Hospital of Zhangjiagang City, Suzhou Municipal Hospital, Liaocheng People's Hospital, Jining First People's Hospital, Qilu Hospital of Shandong University (Qingdao), Weifang People's Hospital（The First Affiliated Hospital of Shandong Second Medical University）, Dezhou Hospital Qilu Hospital of Shandong University, Second Affiliated Hospital of Wenzhou Medical University, The Affiliated Hospital of Xuzhou Medical University, Hainan General Hospital, Southwest Hospital （The First Hospital Affiliated to AMU）, The Peoples' Hospital of Jiaozuo City, Kaifeng Central Hospital, Henan Province, P.R. China, Zhumadian Center Hospital, Zhoukou Central Hospital, Zhengzhou Center Hospital Affiliated to Zhengzhou University, Anyang People's Hospital, The First Affiliated Hospital of Zhengzhou University, The Third Affiliated Hospital of Henan Medical University, Nanyang Central Hosptial, Xuchang Central Hospital, Sanmenxia Central Hospital, The Second Hospital & Clinical Medical School, Lanzhou University, General Hospital of Ningxia Medical University
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Currently, the treatment for ventriculitis is challenging, with poor prognosis. The mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy.
Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. High-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.
This multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with ventriculitis.
Detailed description
Ventriculitis is a severe infectious disease of the central nervous system with diverse etiologies. Ventriculitis is associated not only with community-acquired diseases but also, more importantly, with invasive clinical procedures, including craniotomy, external ventricular drainage (EVD), lumbar cistern drainage, V-P shunt, and deep brain stimulation, among others. Depending on the diagnostic criteria, the incidence of post-neurosurgery ventriculitis ranges from approximately 5% to 20%, with risk factors including age, prolonged placement of EVD, and intracranial hemorrhage. Besides, the pathogens leading to ventricular infection are also diverse, with the main pathogens including coagulase-negative Staphylococci, Staphylococcus aureus, Propionibacterium acnes, and Gram-negative bacilli.
The treatment for ventriculitis is challenging, with poor prognosis. Under currently widely adopted treatment strategies, the mortality rate of ventriculitis is generally reported to be higher than 30%, with the highest reaching over 75%. Even among survivors, over 60% suffer from a variety of neurological sequelae, including cognitive impairment, gait disturbances, paralysis, behavioral disorders, and epilepsy. This imposes significant burden on families and society. Therefore, how to further improve prognosis of ventriculitis, and reduce the mortality and disability rates, remains to be addressed.
Currently, treatments for ventriculitis recommended by guidelines primarily focus on the selection and administration of antibiotics, while the effects of surgical interventions have not been fully elucidated. As an infectious disease, surgical procedures such as irrigation and drainage have the potential to play a role in reducing infection and improving prognosis for ventriculitis.
In recent years, several studies have explored the use of ventricular irrigation in ventriculitis, indicating that ventricular irrigation techniques (including endoscopic ventricular irrigation and dual catheter irrigation techniques) via replacing saline and draining purulent cerebrospinal fluid (CSF), may accelerate the control of ventricular infection, mitigate damage to the central nervous system caused by infections, improve the prognosis of ventriculitis, and reduce complications such as hydrocephalus. However, current studies are still relatively scarce, and mostly case reports and retrospective studies. A prospective controlled study that included 33 patients with ventriculitis divided participants into groups receiving ventricular irrigation treatment and conventional treatment. The study results showed that compared to conventional treatment, ventricular irrigation resulted in higher mRS prognosis scores, shorter hospital stays, and the study also showed a trend towards reduced mortality in irrigation group. However, this study was limited by a small sample size, limited study endpoints and not strictly randomized. Currently, high-quality evidence is still lacking for the application of ventricular irrigation in ventriculitis.
Based on these considerations, this multicenter randomized controlled trial aims to explore the safety and effectiveness of ventricular irrigation compared to conventional treatment for ventriculitis, analyze the effectiveness of ventricular irrigation across different pathogen subgroups, and investigate independent risk factors for different prognostic states in patients with ventriculitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Conventional treatments for ventriculitis, including: external ventricular drainage or lumbar cistern drainage for continuous drainage, systemic and intrathecal antibiotics along with other supportive care. The treatment plan, including the type, dosage, and duration of antibiotics, follows guidelines "2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis" and "Chinese Expert Consensus on Diagnosis and Treatment of Central Nervous System Infections in Neurosurgery (2021 Edition)". |
| Ventricular irrigation group | Experimental | Procedure: Ventricular irrigationIntervention group employs catheter ventricular irrigation with various forms. Lavage is performed with each time at least 200ml of normal saline, and irrigation treatment over 7 days. Additional treatments, including the administration of antibiotics, are consistent with those in the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years old;
- CSF is purulent (it appears cloudy or yellow) and white blood cell count over 1000×10^6/L.
- Fever (>38.0°C)
- Meet at least one of the following: 1. Patient has organism(s) identified from CSF by a culture or non-culture based microbiologic testing method; 2. Cranial CT or MRI indicating intraventricular floccule or pus.
- With consent form
Key exclusion criteria (4 listed)
- With GCS score of 3
- With unstable vital signs such as no spontaneous breathing and blood pressure maintenance drugs
- With severe propensity for bleeding (Such as coagulation dysfunction, active bleeding, etc.), and unable to tolerate the surgical procedures or operations related to ventricular irrigation treatment.
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ventricular irrigationCatheter ventricular irrigation can be employed by various forms. Lavage is performed with with each time at least 200ml of saline. Aside from lavage sessions, the lavage is paused, but continuous CSF drainage remains open. | Procedure or surgery | Ventricular irrigation group |
Primary outcome
Clinical cure rate
Time frame: 4 weeks after enrollment
Clinical cure rate at 4 weeks after enrollment and randomization
6 secondary outcomes
GOSE
Time frame: up 6 months after enrollment and randomization
Microbial clearance rate
Time frame: 4 weeks after enrollment
CSF test results
Time frame: At 8th day after enrollment, and within 1 week before discharge
Cranial CT or MRI indicating
Time frame: At 8th day after enrollment, and within 1 week before discharge
Length of ICU stay and hospital stay
Time frame: up to 6 months after enrollment and randomization
Complications
Time frame: up to 6 months after enrollment and randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 28203777Tunkel AR, Hasbun R, Bhimraj A, Byers K, Kaplan SL, Scheld WM, van de Beek D, Bleck TP, Garton HJL, Zunt JR. 2017 Infectious Diseases Society of America's Clinical Practice Guidelines for Healthcare-Associated Ventriculitis and Meningitis. Clin Infect Dis. 2017 Mar 15;64(6):e34-e65. doi: 10.1093/cid/ciw861.
- Background: PubMed 32886918Al Menabbawy A, El Refaee E, Soliman MAR, Elborady MA, Katri MA, Fleck S, Schroeder HWS, Zohdi A. Outcome improvement in cerebral ventriculitis after ventricular irrigation: a prospective controlled study. J Neurosurg Pediatr. 2020 Sep 4;26(6):682-690. doi: 10.3171/2020.5.PEDS2063. Print 2020 Dec 1.
- Background: PubMed 33334204Hasbun R. Healthcare-associated ventriculitis: current and emerging diagnostic and treatment strategies. Expert Rev Anti Infect Ther. 2021 Aug;19(8):993-999. doi: 10.1080/14787210.2021.1866544. Epub 2020 Dec 24.
- Background: PubMed 25687249Humphreys H, Jenks PJ. Surveillance and management of ventriculitis following neurosurgery. J Hosp Infect. 2015 Apr;89(4):281-6. doi: 10.1016/j.jhin.2014.12.019. Epub 2015 Jan 29.
- Background: PubMed 30899767Rogers T, Sok K, Erickson T, Aguilera E, Wootton SH, Murray KO, Hasbun R. Impact of Antibiotic Therapy in the Microbiological Yield of Healthcare-Associated Ventriculitis and Meningitis. Open Forum Infect Dis. 2019 Feb 6;6(3):ofz050. doi: 10.1093/ofid/ofz050. eCollection 2019 Mar.
- Background: PubMed 35250284Karvouniaris M, Brotis A, Tsiakos K, Palli E, Koulenti D. Current Perspectives on the Diagnosis and Management of Healthcare-Associated Ventriculitis and Meningitis. Infect Drug Resist. 2022 Feb 28;15:697-721. doi: 10.2147/IDR.S326456. eCollection 2022.
- Background: PubMed 30172065Karvouniaris M, Brotis AG, Tsiamalou P, Fountas KN. The Role of Intraventricular Antibiotics in the Treatment of Nosocomial Ventriculitis/Meningitis from Gram-Negative Pathogens: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Dec;120:e637-e650. doi: 10.1016/j.wneu.2018.08.138. Epub 2018 Aug 29.
- Background: PubMed 34095339Luque-Paz D, Revest M, Eugene F, Boukthir S, Dejoies L, Tattevin P, Le Reste PJ. Ventriculitis: A Severe Complication of Central Nervous System Infections. Open Forum Infect Dis. 2021 Apr 29;8(6):ofab216. doi: 10.1093/ofid/ofab216. eCollection 2021 Jun.
- Background: PubMed 28533993Chan AK, Birk HS, Yue JK, Winkler EA, McDermott MW. Bilateral External Ventricular Drain Placement and Intraventricular Irrigation Combined with Concomitant Serial Prone Patient Positioning: A Novel Treatment for Gravity-Dependent Layering in Bacterial Ventriculitis. Cureus. 2017 Apr 18;9(4):e1175. doi: 10.7759/cureus.1175.
- Background: PubMed 27219537Terada Y, Mineharu Y, Arakawa Y, Funaki T, Tanji M, Miyamoto S. Effectiveness of neuroendoscopic ventricular irrigation for ventriculitis. Clin Neurol Neurosurg. 2016 Jul;146:147-51. doi: 10.1016/j.clineuro.2016.05.010. Epub 2016 May 9.
- Background: PubMed 29995267Gaderer C, Schaumann A, Schulz M, Thomale UW. Neuroendoscopic lavage for the treatment of CSF infection with hydrocephalus in children. Childs Nerv Syst. 2018 Oct;34(10):1893-1903. doi: 10.1007/s00381-018-3894-7. Epub 2018 Jul 11.
- Background: PubMed 32087178Qin G, Liang Y, Xu K, Xu P, Ye J, Tang X, Lan S. Neuroendoscopic lavage for ventriculitis: Case report and literature review. Neurochirurgie. 2020 Apr;66(2):127-132. doi: 10.1016/j.neuchi.2019.12.005. Epub 2020 Feb 19.
- Individual participant dataSharing planned: Yes. Researchers who submit a methodologically sound study proposal that is approved by the management committee can have access to the study protocol, individual participant data and data dictionary. A Data Access Agreement is required, and all access must comply with regulatory restrictions imposed on the original study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jiyao Jiang, Dr principal investigator
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Junfeng Feng, Dr study director
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Qinghua Wang, Dr study director
Southern Medical University, China
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventricular irrigation in people with Central Nervous System Infections, run by RenJi Hospital at 35 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiyao Jiang, Dr (021-68383729, jiyaojiang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical cure rate (time frame: 4 weeks after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06358209, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.