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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

Must not have

Patients aged < 18 years old

Patients with signs of meningitis, ventriculitis or any other infection at presentation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up evd insertion until discharge- estimated period of time is 3 weeks

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am over 18 and need an EVD for my stroke or brain hemorrhage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

I show signs of brain infections like meningitis.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and evd insertion until discharge- estimated period of time is 3 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ventriculitis extending from EVD insertion until discharge

Secondary study objectives

Class of infecting organism

Incidence of nosocomial infections

Mortality

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 3Eligibility criteria met