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

Phase 1

Recruiting

• Conditions: Intracerebral Hemorrhage; Subarachnoid Hemorrhage; Ventriculitis, Cerebral; Hydrocephalus
• Interventions: Drug: long term prophylactic antibiotics (Nafcillin or Doxycycline)

• Registration Number: NCT05001750
• Lead Sponsor: Montefiore Medical Center

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).

Study Timeline

• Study Start: 2021-06-14
• Study First Submitted: 2021-06-25
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuous antibiotic use until the EVD is removed	long term prophylactic antibiotics (Nafcillin or Doxycycline)	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.

Primary Outcome Measures

Name	Time	Method
Ventriculitis extending from EVD insertion until discharge	EVD insertion until discharge- estimated period of time is 2 weeks	Patient has organism(s) identified from (CSF) by a culture or (i.e.; PCR) (1) or (2) must be met: Patient has at least two of the following: a) fever (\>38.0°C) or headache, b) meningeal sign(s), c) cranial nerve sign(s); And at least one of the following: d) increased white cells, elevated protein, and decreased glucose in CSF , e) organism(s) seen on Gram stain of CSF., f) organism(s) identified from blood by a culture or non-culture based microbiologic testing method which is performed for purposes of clinical diagnosis or treatment, g) diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism; 1. Patient has organism(s) identified from cerebrospinal fluid (CSF) by a culture or non-culture based microbiologic testing method (i.e.; PCR) which is performed for purposes of clinical diagnosis or treatment OR; 2. Patient has at least two of the following:, a) fever (\>38.0°C) or headache ,b) meningeal sign(s), c) cranial nerve sign(s)

Secondary Outcome Measures

Name	Time	Method
Incidence of nosocomial infections	EVD insertion until discharge- estimated period of time is 2 weeks	incidence of C. difficile or multidrug resistant nosocomial infections in participants especially those who are on a longer course of antibiotics
Time to infection	EVD insertion until discharge- estimated period of time is 2 weeks	Evaluate time to infection from time to EVD placement
Class of infecting organism	EVD insertion until discharge- estimated period of time is 2 weeks	assess if the infections that occur in both treatment groups are caused by the same type of pathogen
overall morbidity which is morbidity from all causes	EVD insertion until discharge- estimated period of time is 2 weeks	includes: high grade fever (\>101 degrees Fahrenheit), repositioning of EVD, post procedural hemorrhage, or new catheter placement due to new bleeding (at a different location than original), need for permanent CSF drainage, i.e. ventriculoperitoneal shunt
Mortality	EVD insertion until discharge- estimated period of time is 3 weeks	mortality from all causes that will be recorded along with cause of death if patient dies during the period of insertion of EVD until one week after its removal

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States