Recruiting
Phase 1

Prophylactic Antibiotics

Sponsor:

Montefiore Medical Center

Code:

NCT05001750

Conditions

Subarachnoid Hemorrhage

Intracerebral Hemorrhage

Ventriculitis, Cerebral

Hydrocephalus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Long term (continuous) prophylactic antibiotics

24 hours antibiotics

Study Details

Brief 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 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.

Conditions

Subarachnoid Hemorrhage

Intracerebral Hemorrhage

Ventriculitis, Cerebral

Hydrocephalus

Study ID

NCT05001750

Start date

Jun 14, 2021

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Continuous antibiotic use until the EVD is removed

Continuous prophylactic antibiotic use until the EVD is removed. Antibiotics will begin no more than sixty minutes pre-procedure.

experimental: Antibiotics for a total of twenty-four hours

Antibiotics for a total of twenty-four hours. Antibiotics will begin no more than sixty minutes pre-procedure.

Interventions

Long term (continuous) prophylactic antibiotics

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 antibiotics

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.

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 ]

Central Contacts and Locations

Central contacts

David C Altschul, MD

7189204965daltschul@montefiore.org

Genesis Liriano

7189202469gliriano@montefiore.org

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10452

Contacts

Genesis Liriano, MD

718-920-2469gliriano@montefiore.org

Dhrumil Vaishnav

dhrumhil.vaishnav@einsteinmed.edu

Principal Investigator:

David Altschul, MD

More Information

Sponsor

Montefiore Medical Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • Subarachnoid hemorrhage
  • Intracerebral Hemorrhage
  • Ventriculitis
  • Hydrocephalus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-08-10.