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

2021-12680

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

2021-06-14

2024-06-01

2024-06-01

Recruiting

Early phase I

84

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 84, 'type': 'ESTIMATED'}}

2023-07-27