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Prophylactic Antibiotics for Hydrocephalus
Phase 1
Recruiting
Led By David C Altschul, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients over the age of 18 years and diagnosed with a subarachnoid hemorrhage, intracerebral hemorrhage or acute ischemic stroke who require an EVD for management of their underlying condition
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evd insertion until discharge- estimated period of time is 3 weeks
Awards & highlights
Study Summary
This trial is testing whether or not prophylactic antibiotic use for the entire duration of an EVD is necessary.
Who is the study for?
This trial is for adults over 18 with subarachnoid hemorrhage, intracerebral hemorrhage, or acute ischemic stroke needing an EVD. It's not for those who had brain procedures within the last month, were on antibiotics recently, have low white blood cell counts, are pregnant or imprisoned.Check my eligibility
What is being tested?
The study tests if long-term prophylactic antibiotics (Nafcillin or Doxycycline) are beneficial alongside antibiotic-coated EVDs. Participants will either receive antibiotics for 24 hours or throughout their entire EVD treatment duration.See study design
What are the potential side effects?
Potential side effects of Nafcillin and Doxycycline include allergic reactions, gastrointestinal issues like nausea and diarrhea, liver toxicity, and possibly increased resistance to antibiotics.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 and need an EVD for my stroke or brain hemorrhage.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evd insertion until discharge- estimated period of time is 3 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evd insertion until discharge- estimated period of time is 3 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ventriculitis extending from EVD insertion until discharge
Secondary outcome measures
Class of infecting organism
Incidence of nosocomial infections
Mortality
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: continuous antibiotic use until the EVD is removedExperimental Treatment1 Intervention
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.
Group II: antibiotics for a total of twenty-four hoursActive Control1 Intervention
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.
Find a Location
Who is running the clinical trial?
Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
582,192 Total Patients Enrolled
3 Trials studying Stroke
28 Patients Enrolled for Stroke
David C Altschul, MDPrincipal InvestigatorMontefiore Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 and need an EVD for my stroke or brain hemorrhage.If my EVD fails, I will be given antibiotics before it's replaced and stay in my treatment group.I have not had any brain surgery in the last 30 days.You have a low level of white blood cells at the start of the study.You took antibiotics in the week before coming to the study.I am under 18 years old.I show signs of brain infections like meningitis.
Research Study Groups:
This trial has the following groups:- Group 1: continuous antibiotic use until the EVD is removed
- Group 2: antibiotics for a total of twenty-four hours
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA sanction using antibiotics to prevent disease in the long-term?
"With limited clinical data available to support the safety and efficacy of long term prophylactic antibiotics, this medication earned a score of 1."
Answered by AI
Are researchers currently seeking participants for this research?
"The clinical trial's info on clinicaltrials.gov suggests that recruitment is not presently available. Initially posted in June 14th 2021 and most recently updated May 4th 2022, this medical experiment has ceased adding participants; however 391 other trials are currently open for enrolment at the moment."
Answered by AI
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