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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT05001750
Phase
PHASE1
Status
Recruiting
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Conditions

  • Hydrocephalus
  • Intracerebral Hemorrhage
  • Subarachnoid Hemorrhage
  • Ventriculitis, Cerebral

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Long term (continuous) prophylactic antibiotics — DRUG
    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 — DRUG
    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 Details

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.

Key Dates

Start date
Jun 14, 2021
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10452
Genesis Liriano, MD
[email protected]
718-920-2469
Lavinia C Williams
[email protected]
7189202910
David Altschul, MD (PRINCIPAL_INVESTIGATOR)

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