Subarachnoid HemorrhagePhase 1NCT05001750
Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
A Phase 1 study testing Long term (continuous) prophylactic antibiotics and 24 hours antibiotics in people with Subarachnoid Hemorrhage and Intracerebral Hemorrhage, run by Montefiore Medical Center at 1 site in United States.
Trial summary
The principal objective of this study is to compare the incidence of ventriculostomy related infections (VRIs) in patients who receive twenty-four hours of antibiotics, beginning no more than sixty minutes prior to EVD placement, to the incidence of VRIs in patients who also receive a pre-procedural dose of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Ventriculitis, Cerebral
- What is being tested?
- Long term (continuous) prophylactic antibiotics and 24 hours antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to Aug 2028
- Phase
- Phase 1
- 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
- patients over the age of 18 years
- patients diagnosed with a subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke who require an EVD for management of their underlying condition. In certain cases (a small minority), an EVD must be replaced due to failure (i.e., blood clot interrupting flow). In such cases, patients will be re-dosed with antibiotics prior to catheter exchange in typical fashion and continue in their previously randomized treatment group
Who cannot join
- patients who were on antibiotics within the week prior to admission
- patients with leukopenia (<5000) at baseline
- patients with signs of meningitis, ventriculitis or any other infection at presentation
- patients who are pregnant or prisoners
- patients aged < 18 years old
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10452
Genesis Liriano, MD, 718-920-2469, gliriano@montefiore.org
Dhrumil Vaishnav, dhrumhil.vaishnav@einsteinmed.edu
About this study
Official title: Are Long Term Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
The principal objective of this study is to compare the incidence of ventriculostomy related infections (VRIs) in patients who receive twenty-four hours of antibiotics, beginning no more than sixty minutes prior to EVD placement, to the incidence of VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain (EVD). At this time, the duration of prophylactic antibiotic use with antibiotic impregnated EVDs is unknown.
Read the detailed description
Intracranial hemorrhage (ICH), which include subarachnoid hemorrhage (SAH), intraparenchymal hemorrhage (IPH) and intraventricular hemorrhage (IVH) affects nearly 30,000 every year in US alone. Despite rapid advances in treatment of just one of these pathologies, SAH, the case fatality rate remains at 32.2% in US. Successful post interventional outcome of patients suffering from SAH depends on the management of a multitude of secondary neurological complications, including prevention of re-hemorrhage, vasospasm, hydrocephalus, increased intracranial pressure (ICP), and seizure. A major component of this care is placement of an external ventricular drain (EVD), which is routine in patients suffering from SAH to manage ICP and to treat hydrocephalus.
Placement of an EVD, however, is not without risk, in particular with regards to infection, commonly referred to as Ventriculostomy Related Infection (VRI). The rate of VRIs has been reported to range widely from 0% to 40% however, with an increased risk in patients suffering from hemorrhage or any vascular diseases (28.6%) in this subgroup, while typically lower (18.5%) in patients suffering from other neurosurgical diagnoses.
Ventriculostomy related infections have been associated with increased delayed cerebral ischemia (a.k.a.; vasospasm), extended hospital duration, increased mortality and higher hospital costs. Despite the importance of management and prevention of VRIs, there hasn't been any clear consensus on administration of antibiotics post-procedurally. This is perpetuated by the fact that each institution, and even providers within institutions, have varying definitions of VRIs, and their own protocols regarding administration of antibiotics.
Although there is an established protocol for insertion of EVD, which include pre-procedural intravenous antibiotic administration, there is no consensus on duration of post-operative antibiotics, despite the fact that successful patient outcomes depend on management of these VRIs.
Further complicating the problem is the growing concern over increasing resistance to gram-positive organisms due to overuse of systemic antibiotics, as well as development of Clostridium difficile infection. As a result, practice is quite variable, based upon individual clinician preferences, rather than evidence based. Determining optimal strategies and protocols to minimize the incidence of VRI, while ensuring responsible antibiotic usage, thereby minimizing their deleterious effects on both individuals and communities, is of chief interest.
These universal concerns and questions deserve a new formal study in this initial feasibility study.
- Being tested
- Long term (continuous) prophylactic antibiotics, 24 hours antibiotics
- Keywords
- Subarachnoid hemorrhage, Intracerebral Hemorrhage, Ventriculitis, Hydrocephalus
- Medical subject headings
- Subarachnoid Hemorrhage, Cerebral Hemorrhage, Cerebral Ventriculitis, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long term (continuous) prophylactic antibioticsDrug
VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain. Nafcillin 1-2 grams every 6 hours (depending on weight) until the EVD is removed. If penicillin allergic, Doxycycline 100mg every 12 hours until the EVD is removed.
24 hours antibioticsDrug
Nafcillin 1-2 grams every 6 hours (depending on weight) for a total of 24 hours. If penicillin allergic, Doxycycline 100mg every 12 hours for a total of 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Continuous antibiotic use until the EVD is removed | Experimental | Continuous prophylactic antibiotic use until the EVD is removed. Antibiotics will begin no more than sixty minutes pre-procedure. Receives: Drug: Long term (continuous) prophylactic antibiotics |
| Antibiotics for a total of twenty-four hours | Experimental | Antibiotics for a total of twenty-four hours. Antibiotics will begin no more than sixty minutes pre-procedure. Receives: Drug: 24 hours antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Cerebrospinal Fluid Positive (CSF+) VRI
A VRI will be defined as an infection of the CNS including abscess (when occurring after EVD placement), ventriculitis, or meningitis. To receive a diagnosis of meningitis or ventriculitis, NHSN criteria (1) OR (2) must be met:
- Patient has organism(s) identified from CSF by a culture or non-culture based microbiological method (PCR) performed for purposes of clinical diagnosis or treatment OR
- Patient has 2 or more of:
- fever (>38.0°C) or headache
- meningeal sign(s)
- cranial nerve sign(s) AND 1 or more of:
- increased white cells, elevated protein, and decreased glucose in CSF (per reporting lab's reference range)
- organism(s) seen on Gram stain of CSF
- organism(s) identified from blood by a culture or non-culture based microbiologic testing method performed for purposes of clinical diagnosis or treatment (not Active Surveillance Culture/Testing)
- diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism
Measured: From EVD insertion until discharge - estimated period of time is 2 weeks
Secondary outcomes (6)
Class of infecting organism
Class of infecting organisms identified will be summarized by study arm to assess whether the infections that occur in both treatment groups are caused by the same type of pathogen. The class of infecting organism will be summarized by study arm.
Measured: From EVD insertion until discharge - estimated period of time is 2 weeks
Time to infection
Time to infection will be assessed from the time of EVD placement until discharge. Results will be summarized by study arm using descriptive statistics.
Measured: From EVD insertion until discharge - estimated period of time is 2 weeks
Number of attempts at EVD catheter insertion
The number of attempts to insert the catheter will be evaluated. This outcome will be used to determine any subsequent effect catheter placement may have had on incidence of infection for each treatment modality. The number of placement attempts will be summarized by study arm.
Measured: From EVD insertion until discharge - estimated period of time is 2 weeks
Incidence of nosocomial infections
The incidence of nosocomial infections of C. difficile or other multidrug resistant nosocomial infections in participants will be evaluated. Incidence in the context of this study will equal the number of new EVD-related infections divided by the total EVD days at risk and expressed as a percentage. Results will be summarized by study arm using descriptive statistics.
Measured: From EVD insertion until discharge - estimated period of time is 2 weeks
Overall Morbidity
Overall morbidity, defined as morbidity from all causes, will be determined. This will include any morbidity from high grade fever (>101 degrees Fahrenheit), repositioning of EVD, post procedural hemorrhage, or new catheter placement due to new bleeding (at a different location than original), or need for permanent CSF drainage (i.e. ventriculoperitoneal shunt). Morbidity will be summarized by study arm.
Measured: From EVD insertion until discharge - estimated period of time is 2 weeks
Overall Mortality
Overall mortality, defined as mortality from all causes, will be determined. Mortality along with cause of death will be recorded and summarized for patients who die during the period of insertion of EVD until one week after its removal.
Measured: From EVD insertion until discharge - estimated period of time is 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start14 Jun 2021
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be randomized into one of two groups, either continuous antibiotic usage until the EVD is removed or antibiotics for a total of twenty-four hours; in both cases antibiotics will begin no more than sixty minutes pre-procedure.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David C Altschul, MD, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001750
- Sponsor's protocol ID
- 2021-12680
- Status last verified
- Aug 2026
- First submitted
- 25 Jun 2021
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nieuwkamp DJ, Setz LE, Algra A, Linn FH, de Rooij NK, Rinkel GJ. Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis. Lancet Neurol. 2009 Jul;8(7):635-42. doi: 10.1016/S1474-4422(09)70126-7. Epub 2009 Jun 6.
PubMed 19501022Lozier AP, Sciacca RR, Romagnoli MF, Connolly ES Jr. Ventriculostomy-related infections: a critical review of the literature. Neurosurgery. 2002 Jul;51(1):170-81; discussion 181-2. doi: 10.1097/00006123-200207000-00024.
PubMed 12182415Foreman PM, Chua M, Harrigan MR, Fisher WS 3rd, Vyas NA, Lipsky RH, Walters BC, Tubbs RS, Shoja MM, Griessenauer CJ. Association of nosocomial infections with delayed cerebral ischemia in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2016 Dec;125(6):1383-1389. doi: 10.3171/2015.10.JNS151959. Epub 2016 Feb 12.
PubMed 26871202Frontera JA, Fernandez A, Schmidt JM, Claassen J, Wartenberg KE, Badjatia N, Parra A, Connolly ES, Mayer SA. Impact of nosocomial infectious complications after subarachnoid hemorrhage. Neurosurgery. 2008 Jan;62(1):80-7; discussion 87. doi: 10.1227/01.NEU.0000311064.18368.EA.
PubMed 18300894Lyke KE, Obasanjo OO, Williams MA, O'Brien M, Chotani R, Perl TM. Ventriculitis complicating use of intraventricular catheters in adult neurosurgical patients. Clin Infect Dis. 2001 Dec 15;33(12):2028-33. doi: 10.1086/324492. Epub 2001 Nov 9.
PubMed 11712094Aucoin PJ, Kotilainen HR, Gantz NM, Davidson R, Kellogg P, Stone B. Intracranial pressure monitors. Epidemiologic study of risk factors and infections. Am J Med. 1986 Mar;80(3):369-76. doi: 10.1016/0002-9343(86)90708-4.
PubMed 3953614Mayhall CG, Archer NH, Lamb VA, Spadora AC, Baggett JW, Ward JD, Narayan RK. Ventriculostomy-related infections. A prospective epidemiologic study. N Engl J Med. 1984 Mar 1;310(9):553-9. doi: 10.1056/NEJM198403013100903.
PubMed 6694707Wong GK, Poon WW. Ventriculostomy infections. J Neurosurg. 2006 Sep;105(3):506-7; author reply 507. doi: 10.3171/jns.2006.105.3.506. No abstract available.
PubMed 16961156Poblete R, Zheng L, Raghavan R, Cen S, Amar A, Sanossian N, Mack W, Kim-Tenser M. Trends in Ventriculostomy-Associated Infections and Mortality in Aneurysmal Subarachnoid Hemorrhage: Data From the Nationwide Inpatient Sample. World Neurosurg. 2017 Mar;99:599-604. doi: 10.1016/j.wneu.2016.12.073. Epub 2016 Dec 27.
PubMed 28034809Camacho EF, Boszczowski I, Basso M, Jeng BC, Freire MP, Guimaraes T, Teixeira MJ, Costa SF. Infection rate and risk factors associated with infections related to external ventricular drain. Infection. 2011 Feb;39(1):47-51. doi: 10.1007/s15010-010-0073-5. Epub 2011 Jan 25.
PubMed 21264679
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Long Term Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
- ClinicalTrials.gov ID
- NCT05001750
- Acronym / sponsor ID
- 2021-12680
- Keywords
- Subarachnoid hemorrhage, Intracerebral Hemorrhage, Ventriculitis, Hydrocephalus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 12 Aug 2021 (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.
The principal objective of this study is to compare the incidence of ventriculostomy related infections (VRIs) in patients who receive twenty-four hours of antibiotics, beginning no more than sixty minutes prior to EVD placement, to the incidence of VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain (EVD). At this time, the duration of prophylactic antibiotic use with antibiotic impregnated EVDs is unknown.
Detailed description
Intracranial hemorrhage (ICH), which include subarachnoid hemorrhage (SAH), intraparenchymal hemorrhage (IPH) and intraventricular hemorrhage (IVH) affects nearly 30,000 every year in US alone. Despite rapid advances in treatment of just one of these pathologies, SAH, the case fatality rate remains at 32.2% in US. Successful post interventional outcome of patients suffering from SAH depends on the management of a multitude of secondary neurological complications, including prevention of re-hemorrhage, vasospasm, hydrocephalus, increased intracranial pressure (ICP), and seizure. A major component of this care is placement of an external ventricular drain (EVD), which is routine in patients suffering from SAH to manage ICP and to treat hydrocephalus.
Placement of an EVD, however, is not without risk, in particular with regards to infection, commonly referred to as Ventriculostomy Related Infection (VRI). The rate of VRIs has been reported to range widely from 0% to 40% however, with an increased risk in patients suffering from hemorrhage or any vascular diseases (28.6%) in this subgroup, while typically lower (18.5%) in patients suffering from other neurosurgical diagnoses.
Ventriculostomy related infections have been associated with increased delayed cerebral ischemia (a.k.a.; vasospasm), extended hospital duration, increased mortality and higher hospital costs. Despite the importance of management and prevention of VRIs, there hasn't been any clear consensus on administration of antibiotics post-procedurally. This is perpetuated by the fact that each institution, and even providers within institutions, have varying definitions of VRIs, and their own protocols regarding administration of antibiotics.
Although there is an established protocol for insertion of EVD, which include pre-procedural intravenous antibiotic administration, there is no consensus on duration of post-operative antibiotics, despite the fact that successful patient outcomes depend on management of these VRIs.
Further complicating the problem is the growing concern over increasing resistance to gram-positive organisms due to overuse of systemic antibiotics, as well as development of Clostridium difficile infection. As a result, practice is quite variable, based upon individual clinician preferences, rather than evidence based. Determining optimal strategies and protocols to minimize the incidence of VRI, while ensuring responsible antibiotic usage, thereby minimizing their deleterious effects on both individuals and communities, is of chief interest.
These universal concerns and questions deserve a new formal study in this initial feasibility study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients will be randomized into one of two groups, either continuous antibiotic usage until the EVD is removed or antibiotics for a total of twenty-four hours; in both cases antibiotics will begin no more than sixty minutes pre-procedure.
| Arm | Type | Receives |
|---|---|---|
| Continuous antibiotic use until the EVD is removed | Experimental | Drug: Long term (continuous) prophylactic antibioticsContinuous prophylactic antibiotic use until the EVD is removed. Antibiotics will begin no more than sixty minutes pre-procedure. |
| Antibiotics for a total of twenty-four hours | Experimental | Drug: 24 hours antibioticsAntibiotics for a total of twenty-four hours. Antibiotics will begin no more than sixty minutes pre-procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients over the age of 18 years
- patients diagnosed with a subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke who require an EVD for management of their underlying condition. In certain cases (a small minority), an EVD must be replaced due to failure (i.e., blood clot interrupting flow). In such cases, patients will be re-dosed with antibiotics prior to catheter exchange in typical fashion and continue in their previously randomized treatment group
Key exclusion criteria (5 listed)
- patients who were on antibiotics within the week prior to admission
- patients with leukopenia (<5000) at baseline
- patients with signs of meningitis, ventriculitis or any other infection at presentation
- patients who are pregnant or prisoners
- patients aged < 18 years old
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 |
|---|---|---|
| Long term (continuous) prophylactic antibioticsVRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain. Nafcillin 1-2 grams every 6 hours (depending on weight) until the EVD is removed. If penicillin allergic, Doxycycline 100mg every 12 hours until the EVD is removed. | Drug | Continuous antibiotic use until the EVD is removed |
| 24 hours antibioticsNafcillin 1-2 grams every 6 hours (depending on weight) for a total of 24 hours. If penicillin allergic, Doxycycline 100mg every 12 hours for a total of 24 hours. | Drug | Antibiotics for a total of twenty-four hours |
Primary outcome
Number of Participants with Cerebrospinal Fluid Positive (CSF+) VRI
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
A VRI will be defined as an infection of the CNS including abscess (when occurring after EVD placement), ventriculitis, or meningitis. To receive a diagnosis of meningitis or ventriculitis, NHSN criteria (1) OR (2) must be met: 1. Patient has organism(s) identified from CSF by a culture or non-culture based microbiological method (PCR) performed for purposes of clinical diagnosis or treatment OR 2. Patient has 2 or more of: 1. fever (>38.0°C) or headache 2. meningeal sign(s) 3. cranial nerve sign(s) AND 1 or more of: 4. increased white cells, elevated protein, and decreased glucose in CSF (per reporting lab's reference range) 5. organism(s) seen on Gram stain of CSF 6. organism(s) identified from blood by a culture or non-culture based microbiologic testing method performed for purposes of clinical diagnosis or treatment (not Active Surveillance Culture/Testing) 7. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism
6 secondary outcomes
Class of infecting organism
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Time to infection
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Number of attempts at EVD catheter insertion
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Incidence of nosocomial infections
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Overall Morbidity
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Overall Mortality
Time frame: From EVD insertion until discharge - estimated period of time is 2 weeks
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 Aug 2026.
- Background: PubMed 19501022Nieuwkamp DJ, Setz LE, Algra A, Linn FH, de Rooij NK, Rinkel GJ. Changes in case fatality of aneurysmal subarachnoid haemorrhage over time, according to age, sex, and region: a meta-analysis. Lancet Neurol. 2009 Jul;8(7):635-42. doi: 10.1016/S1474-4422(09)70126-7. Epub 2009 Jun 6.
- Background: PubMed 12182415Lozier AP, Sciacca RR, Romagnoli MF, Connolly ES Jr. Ventriculostomy-related infections: a critical review of the literature. Neurosurgery. 2002 Jul;51(1):170-81; discussion 181-2. doi: 10.1097/00006123-200207000-00024.
- Background: PubMed 26871202Foreman PM, Chua M, Harrigan MR, Fisher WS 3rd, Vyas NA, Lipsky RH, Walters BC, Tubbs RS, Shoja MM, Griessenauer CJ. Association of nosocomial infections with delayed cerebral ischemia in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2016 Dec;125(6):1383-1389. doi: 10.3171/2015.10.JNS151959. Epub 2016 Feb 12.
- Background: PubMed 18300894Frontera JA, Fernandez A, Schmidt JM, Claassen J, Wartenberg KE, Badjatia N, Parra A, Connolly ES, Mayer SA. Impact of nosocomial infectious complications after subarachnoid hemorrhage. Neurosurgery. 2008 Jan;62(1):80-7; discussion 87. doi: 10.1227/01.NEU.0000311064.18368.EA.
- Background: PubMed 11712094Lyke KE, Obasanjo OO, Williams MA, O'Brien M, Chotani R, Perl TM. Ventriculitis complicating use of intraventricular catheters in adult neurosurgical patients. Clin Infect Dis. 2001 Dec 15;33(12):2028-33. doi: 10.1086/324492. Epub 2001 Nov 9.
- Background: PubMed 3953614Aucoin PJ, Kotilainen HR, Gantz NM, Davidson R, Kellogg P, Stone B. Intracranial pressure monitors. Epidemiologic study of risk factors and infections. Am J Med. 1986 Mar;80(3):369-76. doi: 10.1016/0002-9343(86)90708-4.
- Background: PubMed 6694707Mayhall CG, Archer NH, Lamb VA, Spadora AC, Baggett JW, Ward JD, Narayan RK. Ventriculostomy-related infections. A prospective epidemiologic study. N Engl J Med. 1984 Mar 1;310(9):553-9. doi: 10.1056/NEJM198403013100903.
- Background: PubMed 16961156Wong GK, Poon WW. Ventriculostomy infections. J Neurosurg. 2006 Sep;105(3):506-7; author reply 507. doi: 10.3171/jns.2006.105.3.506. No abstract available.
- Background: PubMed 28034809Poblete R, Zheng L, Raghavan R, Cen S, Amar A, Sanossian N, Mack W, Kim-Tenser M. Trends in Ventriculostomy-Associated Infections and Mortality in Aneurysmal Subarachnoid Hemorrhage: Data From the Nationwide Inpatient Sample. World Neurosurg. 2017 Mar;99:599-604. doi: 10.1016/j.wneu.2016.12.073. Epub 2016 Dec 27.
- Background: PubMed 21264679Camacho EF, Boszczowski I, Basso M, Jeng BC, Freire MP, Guimaraes T, Teixeira MJ, Costa SF. Infection rate and risk factors associated with infections related to external ventricular drain. Infection. 2011 Feb;39(1):47-51. doi: 10.1007/s15010-010-0073-5. Epub 2011 Jan 25.
- Individual participant dataSharing planned: No
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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.
David C Altschul, MD principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Long term (continuous) prophylactic antibiotics and 24 hours antibiotics in people with Subarachnoid Hemorrhage and Intracerebral Hemorrhage, run by Montefiore Medical Center at 1 site in United States.
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 2 inclusion and 5 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 David C Altschul, MD (7189204965, daltschul@montefiore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Cerebrospinal Fluid Positive (CSF+) VRI (time frame: From EVD insertion until discharge - estimated period of time is 2 weeks). 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 NCT05001750, which also lists 10 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 Aug 2026.