Antibiotic Use with External Ventricular Drains (EVDs) Study

This study is looking at the best way to use antibiotics to prevent infections in patients who need an external ventricular drain (EVD). An EVD is a tube placed in the brain to help manage pressure or fluid buildup, often after conditions like a subarachnoid hemorrhage (bleeding around the brain) or intracerebral hemorrhage (bleeding inside the brain). The study compares two approaches: giving Nafcillin for 24 hours, or giving Nafcillin for the entire time the EVD is in place. If you are allergic to penicillin, Doxycycline will be used instead. The main goal is to see which approach leads to fewer ventriculostomy related infections (VRIs), which are infections linked to the EVD. You may be eligible if you are over 18 and need an EVD for conditions like subarachnoid hemorrhage or intracerebral hemorrhage. The study is currently unclear about its recruitment status and plans to enroll 84 participants.

Study design
This is an interventional study comparing two different antibiotic treatment durations. It plans to enroll 84 participants.
What's involved
You would receive either 24 hours of antibiotics or continuous antibiotics for the duration of your external ventricular drain. The study will monitor for infections from EVD insertion until discharge, estimated to be about 2 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from EVD insertion until discharge, which is an estimated period of 2 weeks.

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NCT05001750

Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?

Recruiting
PHASE1Ages 18+InterventionalTreatment
Montefiore Medical Center
~84 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:Long term (continuous) prophylactic antibiotics24 hours antibiotics

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Cerebrospinal Fluid Positive (CSF+) VRI
Measured over From EVD insertion until discharge - estimated period of time is 2 weeks
Subarachnoid Hemorrhage
Intracerebral Hemorrhage
Ventriculitis, Cerebral
Hydrocephalus
1 sites across 1 states
New York1
  • David C Altschul, MD · PRINCIPAL_INVESTIGATOR · Montefiore Medical Center

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Eligibility criteria

Inclusion

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

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
  • Number of Participants with Cerebrospinal Fluid Positive (CSF+) VRIFrom 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