Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial PneumoniaPhase 2NCT07512596
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria
A Phase 2 study testing TQD3524, Meropenem for injection and Colistimethate Sodium for Injection in people with Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 27 sites in China.
Trial summary
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia
- What is being tested?
- TQD3524, Meropenem for injection and Colistimethate Sodium for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 27 sitesChina
- Study dates
- 21 Jul 2026to Jul 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old (based on the date of signing the informed consent form);
- The subject (or their guardian) voluntarily signed the informed consent form；
- Acute pulmonary infection with hospitalization duration exceeding 48 hours or within 7 days after discharge; or acute pulmonary infection patients who have undergone mechanical ventilation via oral or nasal tracheal intubation for at least 48 hours;
- Chest imaging examination (X-ray or CT) within 72 hours prior to randomization reveals characteristics of new or worsening pulmonary infiltration;
- At least one of the following physical signs or laboratory abnormalities: ① fever (temperature ≥38℃); ② hypothermia (temperature ≤35℃); ③ elevated peripheral white blood cell count (WBC ≥10×10^9/L); ④ decreased white blood cell count (WBC ≤4.5×10^9/L); ⑤ more than 15% of immature neutrophils such as band forms in peripheral blood;
- At least one of the following clinical symptoms is present: ① new or acute worsening of pulmonary symptoms or signs, such as cough, dyspnea, increased respiratory rate (respiratory rate > 25 breaths per minute), expectoration, or the need for mechanical ventilation; ② hypoxemia (arterial blood gas oxygen partial pressure below 60 mmHg at standard atmospheric pressure, or a progressive decrease in the ratio of oxygen partial pressure to inspired oxygen concentration (PaO2/FiO2)); ③ deteriorating oxygenation requiring replacement of ventilation support system to improve oxygenation, or a change in the level of positive end-expiratory pressure support; ④ new respiratory secretions requiring suction;
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- A specific carbapenem-resistant Gram-negative bacterium was cultured from qualified lower respiratory tract specimens within the first five days/screening period, with in vitro susceptibility testing confirming resistance to carbapenems；
- Female subjects without reproductive potential must meet at least one of the following criteria: a) cessation of regular menstruation for at least 12 consecutive months; b) having undergone hysterectomy and/or bilateral oophorectomy. Female subjects with reproductive potential must have a negative serum pregnancy test result at the screening visit and agree to use reliable contraception throughout the study period;
- Male subjects must agree to adopt reliable contraceptive measures throughout the entire study period.
Who cannot join
- Those who currently suffer from epilepsy/myasthenia gravis or have a history of seizures (excluding febrile seizures in childhood)/myasthenia gravis;
- Those who are undergoing hemodialysis or peritoneal dialysis;
- Combined infections with other lung microbiota: viral pneumonia, fungal pneumonia, pulmonary tuberculosis, atypical pathogen infections, etc；
- Current concurrent infection of other parts/organs;
- Patients with concurrent refractory septic shock, who still exhibit persistent hypotension despite adequate fluid resuscitation or vasopressor therapy prior to randomization;
- Individuals with immune deficiency or compromised immune function, including but not limited to: human immunodeficiency virus infection, hematological malignancies, bone marrow transplantation, immunosuppressive therapy, and systemic corticosteroid treatment (defined as a daily dose equivalent to prednisone ≥20mg and a treatment duration >14 days);
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- During the screening period, any of the following laboratory abnormalities is present: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels are more than 5 times the upper limit of normal, or AST and/or ALT levels are more than 3 times the upper limit of normal and total bilirubin levels are more than 1.5 times the upper limit of normal, or neutrophil count < 1.0×10^9/L, or platelet count < 60×10^9/L; creatinine clearance rate (cLcr) ≤ 50 mL/min;
- Suffering from lung diseases that can interfere with treatment response assessment;
- Patients with lung abscess, empyema, and mechanical obstructive pneumonia;
- New York Heart Association (NYHA) class III-IV heart failure;
- Transplant patients；
- Patients with an estimated survival time of less than 1 month according to the clinical judgment of the researchers;
- Individuals with allergic reactions to polymyxins or carbapenems;
- Sbjects requiring >2 systemic antimicrobial drugs for the treatment of Gram-negative bacterial infections;
- Patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score greater than 30;
- Women who are pregnant or breastfeeding;
- Use potentially effective antibiotics to treat carbapenem resistant gram-negative bacterial infections within 72 hours prior to randomization, and the treatment duration exceeds 24 hours；
- When the culture results of samples from the first 5 days/screening period are available, it is found that the subject has Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia (HAP/VAP) caused by gram-negative bacteria that are expected to have no response to polymyxin drugs;
- Subjects who have participated in other clinical trials within 30 days prior to the first dose of medication;
- Other factors determined by the researcher that make the subject unsuitable for participating in this study.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
China27 sites, 27 recruiting
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102200
Xuzhu Ma, Doctor, 13910204904, mxz@btch.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000
Shibing Zhao, Master, 13855212871, zhaoshibing523@163.com
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Yuanyuan Li, Doctor, 13975806790, Leeround@163.com
- Not yet recruiting
People's Hospital of Hunan Province
Changsha, Hunan, 410005
Yan Cao, Doctor, 15116485862, 13383771@qq.com
- Not yet recruiting
The Third Hospital of Changsha
Changsha, Hunan, 410015
Yingqun Zhu, Master, 13319559218, 1104633835@qq.com
- Not yet recruiting
Chengdu Third People's Hospital
Chengdu, Sichuan, 610031
Guoping Li, Doctor, 18982791605, lzlgp@163.com
- Not yet recruiting
Nuclear Industry 416 Hospital
Chengdu, Sichuan, 610051
ZhiQiang Xu, Master, 13551800077, 20744929@qq.com
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Chun Pan, Doctor, 13814009925, panchun1982@gmail.com
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
Xiaoli Han, Master, 13271943396, hxl093@163.com
- Not yet recruiting
Foshan Nanhai District People's Hospital
Foshan, Guangdong, 528200
Zongmian Zhang, Bachelor, 13590550630, mian74@qq.com
- Not yet recruiting
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000
Shaochun Yang, Master, 13766399775, yangshch680709@hotmail.com
- Not yet recruiting
The First Clinical College of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Chao Zhuo, Doctor, 18928868397, chaosheep@sina.com
- Not yet recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Min Zhang, Doctor, 13482345145, maggie_zhangmin@163.com
- Not yet recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
Haiwen Lu, Doctor, 13917110982, haiwen_lu@163.cm
- Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Lei Huang, Doctor, 13510331883, hl0248@outlook.com
Ruilin Sun, Doctor, 13825167802, hl0248@outlook.com
- Not yet recruiting
The Second Hospital Of Hebei Medical University
Shijiazhuang, Hebei, 050000
Zhigang Cai, Doctor, 18233106552, zhigang_cai@163.com
- Not yet recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Jie Cao, Master, 13132088076, jiecao13995@163.com
- Not yet recruiting
Tianjin First Central Hospital
Tianjin, Tianjin Municipality, 300191
HongMei Gao, Doctor, 13072256661, ghm182@163.com
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiao Tong University
Xi'an, Shaanxi, 710000
YingLi He, Doctor, 18991232863, Heyingli2000@163.com
- Not yet recruiting
Xi'an Chest Hospital
Xi'an, Shaanxi, 710100
Jianying Li, Doctor, 13572168322, 363121217@qq.com
- Not yet recruiting
Yan'an University Xianyang Hospital
Xianyang, Shaanxi, 712000
Jianhou Jia, Master, 13892007197, jjh20@126.com
- Not yet recruiting
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000
Lingfeng Min, Doctor, 18051061783, minlingfeng@126.com
- Not yet recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
Yi Kang, Doctor, 13938553839, 13938553839@163.com
- Not yet recruiting
Zhengzhou Central Hospital
Zhengzhou, Henan, 450007
Yanqiu Gao, Master, 13673999263, 13673999263@163.com
- Not yet recruiting
The Fifth Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yonghai Feng, Master, 13623712087, 13623712087@163.com
- Not yet recruiting
The Second Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Xiaojun Liu, Bachelor, 13939199151, drliuxiaojun@163.com
- Not yet recruiting
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, 519000
Liu Xi, Doctor, 15992670630, liuxi26@mail.sysu.edu.cn
About this study
Official title: Randomized, Double-blind, Parallel-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Polymyxin E2 Mesylate Intravenous Infusion Combined With Nebulized Inhalation in the Treatment of Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia Caused by Carbapenem-resistant Gram-negative Bacteria
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria.
- Being tested
- TQD3524, Meropenem for injection, Colistimethate Sodium for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQD3524Drug
After entering the body, TQD3524 can be hydrolyzed into polymyxin E2 and its derivatives, exerting bactericidal effects .
Meropenem for injectionDrug
Meropenem for injection is a β-lactam.
Colistimethate Sodium for InjectionDrug
Colistimethate Sodium for Injection is a prodrug of polymyxin E. After entering the body, polymyxin E mesylate is hydrolyzed to polymyxin E (colistin), which exerts bactericidal activity.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose TQD3524 + Meropenem for injection | Experimental | TQD3524: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days TQD3524 : 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Receives: Drug: TQD3524; Drug: Meropenem for injection |
| Colistimethate Sodium for Injection + Meropenem for injection (Low-dose control) | Active comparator | Colistimethate Sodium for Injection: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Colistimethate Sodium for Injection: 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Receives: Drug: Meropenem for injection; Drug: Colistimethate Sodium for Injection |
| High-dose TQD3524 + Meropenem for injection | Experimental | TQD3524: 3.75mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days TQD3524 : 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Receives: Drug: TQD3524; Drug: Meropenem for injection |
| Colistimethate Sodium for Injection + Meropenem for injection (High-dose control) | Active comparator | Colistimethate Sodium for Injection: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Colistimethate Sodium for Injection: 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Receives: Drug: Meropenem for injection; Drug: Colistimethate Sodium for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who achieved clinical cure
The proportion of subjects who achieved clinical cure in the modified intention-to-treat (mITT) population at the treatment-end visit (TOC) based on clinical efficacy evaluation.
Measured: Up to 28 days
The percentage difference in subjects achieving clinical cure between the experimental group and the control group
During the TOC visit, the percentage difference in subjects achieving clinical cure between the modified intention-to-treat (mITT) populations of the test group and the control group.
Measured: Up to 28 days
Secondary outcomes (10)
The bacterial clearance rate
The bacterial clearance rate at the Time of Clinical Outcome (TOC) visit and the End of Treatment (EOT) visit in the microbiologically Improved Intent-to-Treat (micro-mITT) population and the Microbiologically Evaluable (ME) population.
Measured: Up to 28 days
The proportion of subjects who achieved clinical cure
The proportion of subjects in the mITT population who achieved clinical cure in the clinical efficacy evaluation at the EOT visit.
Measured: Up to 21 days
The proportion of subjects who achieved clinical cure
The proportion of subjects in the clinically evaluable (CE) population who achieved clinical cure in the clinical efficacy assessment at the EOT visit.
Measured: Up to 21 days
The proportion of subjects who achieved clinical cure
The proportion of subjects in the CE population who achieve clinical cure in the clinical efficacy evaluation during the TOC visit
Measured: Up to 28 days
All-cause mortality
All-cause mortality rate in the mITT population on Day 28 ± 2 after the first dose.
Measured: Up to 28 days
Average duration of mechanical ventilation
The average duration of mechanical ventilation in the mITT population.
Measured: Up to 28 days
Average length of hospital stay
The average length of hospital stay from the first dose to the end of the follow-up period in the mITT population.
Measured: Up to 28 days
Change in APACHE II score
Changes in APACHE II scores before and after treatment in the mITT population. The higher the score, the more severe the condition.
Measured: Up to 28 days
Change value of procalcitonin
Change in procalcitonin levels from baseline during TOC visits in the mITT population.
Measured: Up to 28 days
The proportion of patients experiencing adverse reactions
The proportion of patients experiencing adverse reactions.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start21 Jul 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial PneumoniaStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07512596
- Sponsor's protocol ID
- TQD3524-II-02
- Status last verified
- Sep 2026
- First submitted
- 27 Mar 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Parallel-controlled, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Polymyxin E2 Mesylate Intravenous Infusion Combined With Nebulized Inhalation in the Treatment of Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia Caused by Carbapenem-resistant Gram-negative Bacteria
- ClinicalTrials.gov ID
- NCT07512596
- Acronym / sponsor ID
- TQD3524-II-02
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 6 Apr 2026 (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.
Study on the Safety and Efficacy of Polymyxin E2 Methanesulfonate for Injection in the Treatment of Hospital-Acquired Bacterial Pneumonia/Ventilator-Associated Bacterial Pneumonia Caused by Carbapenem-Resistant Gram-Negative Bacteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-dose TQD3524 + Meropenem for injection | Experimental | Drug: TQD3524, Drug: Meropenem for injectionTQD3524: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days TQD3524 : 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days |
| Colistimethate Sodium for Injection + Meropenem for injection (Low-dose control) | Active comparator | Drug: Meropenem for injection, Drug: Colistimethate Sodium for InjectionColistimethate Sodium for Injection: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Colistimethate Sodium for Injection: 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days |
| High-dose TQD3524 + Meropenem for injection | Experimental | Drug: TQD3524, Drug: Meropenem for injectionTQD3524: 3.75mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days TQD3524 : 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days |
| Colistimethate Sodium for Injection + Meropenem for injection (High-dose control) | Active comparator | Drug: Meropenem for injection, Drug: Colistimethate Sodium for InjectionColistimethate Sodium for Injection: 2.5mg/kg, q12h, intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days Colistimethate Sodium for Injection: 70mg, q12h, nebulized inhalation, for a duration of 7 to 14 days, with a maximum of 21 days Meropenem for injection: 2g, q8h,intravenous drip, for a duration of 7 to 14 days, with a maximum of 21 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old (based on the date of signing the informed consent form);
- The subject (or their guardian) voluntarily signed the informed consent form；
- Acute pulmonary infection with hospitalization duration exceeding 48 hours or within 7 days after discharge; or acute pulmonary infection patients who have undergone mechanical ventilation via oral or nasal tracheal intubation for at least 48 hours;
- Chest imaging examination (X-ray or CT) within 72 hours prior to randomization reveals characteristics of new or worsening pulmonary infiltration;
- At least one of the following physical signs or laboratory abnormalities: ① fever (temperature ≥38℃); ② hypothermia (temperature ≤35℃); ③ elevated peripheral white blood cell count (WBC ≥10×10^9/L); ④ decreased white blood cell count (WBC ≤4.5×10^9/L); ⑤ more than 15% of immature neutrophils such as band forms in peripheral blood;
Key exclusion criteria (20 listed)
- Those who currently suffer from epilepsy/myasthenia gravis or have a history of seizures (excluding febrile seizures in childhood)/myasthenia gravis;
- Those who are undergoing hemodialysis or peritoneal dialysis;
- Combined infections with other lung microbiota: viral pneumonia, fungal pneumonia, pulmonary tuberculosis, atypical pathogen infections, etc；
- Current concurrent infection of other parts/organs;
- Patients with concurrent refractory septic shock, who still exhibit persistent hypotension despite adequate fluid resuscitation or vasopressor therapy prior to randomization;
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 |
|---|---|---|
| TQD3524After entering the body, TQD3524 can be hydrolyzed into polymyxin E2 and its derivatives, exerting bactericidal effects . | Drug | High-dose TQD3524 + Meropenem for injection, Low-dose TQD3524 + Meropenem for injection |
| Meropenem for injectionMeropenem for injection is a β-lactam. | Drug | Colistimethate Sodium for Injection + Meropenem for injection (High-dose control), Colistimethate Sodium for Injection + Meropenem for injection (Low-dose control), High-dose TQD3524 + Meropenem for injection, Low-dose TQD3524 + Meropenem for injection |
| Colistimethate Sodium for InjectionColistimethate Sodium for Injection is a prodrug of polymyxin E. After entering the body, polymyxin E mesylate is hydrolyzed to polymyxin E (colistin), which exerts bactericidal activity. | Drug | Colistimethate Sodium for Injection + Meropenem for injection (High-dose control), Colistimethate Sodium for Injection + Meropenem for injection (Low-dose control) |
Primary outcome
The proportion of subjects who achieved clinical cure
Time frame: Up to 28 days
The proportion of subjects who achieved clinical cure in the modified intention-to-treat (mITT) population at the treatment-end visit (TOC) based on clinical efficacy evaluation.
The percentage difference in subjects achieving clinical cure between the experimental group and the control group
Time frame: Up to 28 days
During the TOC visit, the percentage difference in subjects achieving clinical cure between the modified intention-to-treat (mITT) populations of the test group and the control group.
10 secondary outcomes
The bacterial clearance rate
Time frame: Up to 28 days
The proportion of subjects who achieved clinical cure
Time frame: Up to 21 days
The proportion of subjects who achieved clinical cure
Time frame: Up to 21 days
The proportion of subjects who achieved clinical cure
Time frame: Up to 28 days
All-cause mortality
Time frame: Up to 28 days
Average duration of mechanical ventilation
Time frame: Up to 28 days
Average length of hospital stay
Time frame: Up to 28 days
Change in APACHE II score
Time frame: Up to 28 days
Change value of procalcitonin
Time frame: Up to 28 days
The proportion of patients experiencing adverse reactions
Time frame: Up to 28 days
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 4 Sep 2026.
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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.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TQD3524, Meropenem for injection and Colistimethate Sodium for Injection in people with Hospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial Pneumonia, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 27 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 9 inclusion and 20 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 4 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 27 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yanbin Liu, Doctor (18980601983, dr_liuyanbin@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who achieved clinical cure (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2026.