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

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

Recruiting
18-99 years
All
Phase 1

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Overview

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

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).

Eligibility

Inclusion Criteria:

  • patients over the age of 18 years and 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 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 at presentation,
  • patients who are pregnant or prisoners.
  • patients aged < 18 years old

Study details
    Subarachnoid Hemorrhage
    Intracerebral Hemorrhage
    Ventriculitis
    Cerebral
    Hydrocephalus

NCT05001750

Montefiore Medical Center

27 January 2024

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