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

Last updated: August 14, 2024
Sponsor: Montefiore Medical Center
Overall Status: Active - Recruiting

Phase

1

Condition

Brain Injury

Stroke

Hemorrhage

Treatment

long term prophylactic antibiotics (Nafcillin or Doxycycline)

Clinical Study ID

NCT05001750
2021-12680
  • Ages 18-99
  • All Genders

Study Summary

The length of prophylactic antibiotic use with antibiotic impregnated External Ventricular Drains (EVD)s is unknown. This study is a randomized clinical trial with two arms:

  1. twenty four hours of prophylactic antibiotic use or

  2. prophylactic antibiotic use for entire duration of EVD

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patients over the age of 18 years and patients diagnosed with a subarachnoidhemorrhage, intracerebral hemorrhage or acute ischemic stroke who require an EVD formanagement 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 withantibiotics prior to catheter exchange in typical fashion, and continue in theirpreviously randomized treatment group.

Exclusion

Exclusion Criteria:

  • patients who underwent any intracranial procedure in the 30 days prior,

  • 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 atpresentation,

  • patients who are pregnant or prisoners.

  • patients aged < 18 years old

Study Design

Total Participants: 84
Treatment Group(s): 1
Primary Treatment: long term prophylactic antibiotics (Nafcillin or Doxycycline)
Phase: 1
Study Start date:
June 14, 2021
Estimated Completion Date:
June 30, 2026

Study Description

The principle 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).

Connect with a study center

  • Montefiore Medical Center

    Bronx, New York 10452
    United States

    Active - Recruiting

  • Montefiore Medical center

    Bronx, New York 10452
    United States

    Site Not Available

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