RecruitingPhase 1NCT05001750

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

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


Sponsor

Montefiore Medical Center

Enrollment

84 participants

Start Date

Jun 14, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining whether patients with a brain drain tube (external ventricular drain, or EVD) need prophylactic (preventive) antibiotics to avoid infection when the drain is inserted. EVDs are placed in people who have had brain bleeds or strokes and need the fluid around their brain drained. The study compares antibiotic-coated drains with and without additional antibiotic drugs. You may be eligible if: - You are 18 years or older - You have been diagnosed with a subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke - You require an external ventricular drain (EVD) for your condition You may NOT be eligible if: - You were already on antibiotics within the week before admission - You have a low white blood cell count (leukopenia) at baseline - You show signs of meningitis, ventriculitis, or another infection at admission - You are pregnant or a prisoner - You are under 18 years old Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLong 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.

DRUG24 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.


Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT05001750


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