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

Who is this study for? Patients with a subarachnoid hemorrhage, intracerebral hemorrhage or acute ischemic stroke who require an EVD for management of their underlying condition
What treatments are being studied? Nafcillin or Doxycycline
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
David C Altschul, MD
daltschul@montefiore.org
7189204965
Backup
Genesis Liriano
gliriano@montefiore.org
7189202469
Time Frame
Start Date: 2021-06-14
Estimated Completion Date: 2026-06
Participants
Target number of participants: 84
Treatments
Experimental: Continuous antibiotic use until the EVD is removed
Continuous prophylactic antibiotic use until the EVD is removed. Antibiotics will begin no more than sixty minutes pre-procedure.
Experimental: Antibiotics for a total of twenty-four hours
Antibiotics for a total of twenty-four hours. Antibiotics will begin no more than sixty minutes pre-procedure.
Sponsors
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov