Clinical trial NCT05001750: Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
Official title: Are Long Term Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Subarachnoid Hemorrhage
Intracerebral Hemorrhage
Ventriculitis, Cerebral
Hydrocephalus
Keywords: Subarachnoid hemorrhage
Intracerebral Hemorrhage
Ventriculitis
Hydrocephalus
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2021-08-12
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

Brief summary: 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

Detailed 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 criteria: 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

Primary outcomes:
measure: Ventriculitis extending from EVD insertion until discharge
timeFrame: EVD insertion until discharge- estimated period of time is 2 weeks
Secondary outcomes:
measure: Class of infecting organism
timeFrame: EVD insertion until discharge- estimated period of time is 2 weeks
measure: Time to infection
timeFrame: EVD insertion until discharge- estimated period of time is 2 weeks
measure: Incidence of nosocomial infections
timeFrame: EVD insertion until discharge- estimated period of time is 2 weeks
measure: overall morbidity which is morbidity from all causes
timeFrame: EVD insertion until discharge- estimated period of time is 2 weeks
measure: Mortality
timeFrame: EVD insertion until discharge- estimated period of time is 3 weeks
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: David C Altschul, MD
role: PRINCIPAL_INVESTIGATOR
References: