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 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Montefiore Medical Center
RECRUITING
The Bronx
Contact Information
Primary
David C Altschul, MD
daltschul@montefiore.org
7189204965
Backup
Erida C Rivas
ecastroriv@montefiore.org
7189204965
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 antibiotic use until the EVD is removed. 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.
No_intervention: antibiotics for a total of twenty-four hours
antibiotics for a total of twenty-four hours 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.
Sponsors
Leads: Montefiore Medical Center

This content was sourced from clinicaltrials.gov