Using antibiotics with external ventricular drains to prevent infections
Official title: Are Long Term Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
Run by Montefiore Medical Center · NCT05001750 · Data updated 2026-11-12
This study tests whether giving antibiotics for 24 hours or for the whole time a patient has an external ventricular drain can help prevent infections in people with brain bleeding.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 84 (estimated) |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Status | Recruiting |
| Started | June 14, 2021 |
| Main results expected | August 2028 |
| Study ends | August 2028 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT05001750 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 years old diagnosed with subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke requiring an EVD.
✕Probably not a fit
Patients who have had recent intracranial procedures, are on antibiotics, or have existing infections will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to determine the effectiveness of two different durations of prophylactic antibiotic use in patients requiring external ventricular drains (EVDs) due to conditions like subarachnoid hemorrhage and intracerebral hemorrhage. Participants will be randomly assigned to receive either 24 hours of antibiotics or antibiotics for the entire duration of the EVD. The primary goal is to compare the incidence of ventriculostomy-related infections (VRIs) between the two groups. The antibiotics used in this study include Nafcillin or Doxycycline, administered starting no more than 60 minutes before EVD placement.
Why it matters
Potential benefit: If successful, this study could lead to improved infection prevention strategies for patients with external ventricular drains.
How similar studies have gone: While the specific approach of this study is novel, previous studies have explored antibiotic use in similar contexts, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
-
Montefiore Medical Center
The Bronx, New York, United States Recruiting
Study contacts
- Principal investigator: David C Altschul, MD — Montefiore Medical Center
- Study coordinator: David C Altschul, MD
- Email: daltschul@montefiore.org
- Phone: 7189204965
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.