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RecruitingPhase 1NCT05001750

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

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Trial Parameters

ConditionSubarachnoid Hemorrhage
SponsorMontefiore Medical Center
Study TypeINTERVENTIONAL
PhasePhase 1
Enrollment84
SexALL
Min Age18 Years
Max AgeN/A
Start Date2021-06-14
Completion2026-06
Interventions
Long term (continuous) prophylactic antibiotics24 hours antibiotics

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Brief 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 Criteria

Inclusion Criteria: * patients over the age of 18 years * 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 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

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