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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2026-06-30

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Subarachnoid Hemorrhage Intracerebral Hemorrhage Ventriculitis, Cerebral Hydrocephalus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients will be randomized into one of two groups, either continuous antibiotic usage until the EVD is removed or antibiotics for a total of twenty-four hours; in both cases antibiotics will begin no more than sixty minutes pre-procedure.

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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continuous antibiotic use until the EVD is removed

continuous antibiotic use until the EVD is removed. 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.

Group Type EXPERIMENTAL

long term prophylactic antibiotics (Nafcillin or Doxycycline)

Intervention Type 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 IRB NUMBER: 2021-12680 IRB APPROVAL DATE: 06/14/2021 NOABX in EVD Study 3 (EVD).

antibiotics for a total of twenty-four hours

antibiotics for a total of twenty-four hours 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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long term prophylactic antibiotics (Nafcillin or Doxycycline)

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 IRB NUMBER: 2021-12680 IRB APPROVAL DATE: 06/14/2021 NOABX in EVD Study 3 (EVD).

Intervention Type DRUG

Other Intervention Names

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24 hours antibiotics

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No