Using antibiotics with external ventricular drains to prevent infections
Are Long Term Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
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 |
| Enrollment | 84 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT05001750 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke requiring an EVD.
Not a fit: Patients who have had recent intracranial procedures, are on antibiotics, or have existing infections will not benefit from this study.
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 performed: While the specific approach of this study is novel, previous studies have explored antibiotic use in similar contexts, indicating potential for success.
Eligibility criteria
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 this trial is running
The Bronx, New York
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.