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

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

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

Study Overview

• Status: Recruiting
• Conditions: Subarachnoid Hemorrhage; Intracerebral Hemorrhage; Hydrocephalus; Ventriculitis, Cerebral
• Intervention / Treatment: Drug: long term prophylactic antibiotics (Nafcillin or Doxycycline)

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 Type: Interventional
• Enrollment (Estimated): 84
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: David C Altschul, MD; Phone Number: 7189204965; Email: daltschul@montefiore.org
• Study Contact Backup: Name: Erida C Rivas; Phone Number: 7189204965; Email: ecastroriv@montefiore.org

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10452
      • Recruiting
      • Montefiore Medical Center
      • Principal Investigator: David Altschul, MD
      • Contact: Erida Castro Rivas, MS; Phone Number: 718-920-4965; Email: ecastroriv@montefiore.org
      • Contact: Lavinia C Williams; Phone Number: 7189204965; Email: ecastroriv@montefiore.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: long term prophylactic antibiotics (Nafcillin or Doxycycline); 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 IRB NUMBER: 2021-12680 IRB APPROVAL DATE: 06/14/2021 NOABX in EVD Study 3 (EVD).; Other Names: 24 hours antibiotics
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventriculitis extending from EVD insertion until discharge	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; 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; Patient has at least two of the following:, a) fever (>38.0°C) or headache ,b) meningeal sign(s), c) cranial nerve sign(s)	EVD insertion until discharge- estimated period of time is 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Class of infecting organism	assess if the infections that occur in both treatment groups are caused by the same type of pathogen	EVD insertion until discharge- estimated period of time is 2 weeks
Time to infection	Evaluate time to infection from time to EVD placement	EVD insertion until discharge- estimated period of time is 2 weeks
Incidence of nosocomial infections	incidence of C. difficile or multidrug resistant nosocomial infections in participants especially those who are on a longer course of antibiotics	EVD insertion until discharge- estimated period of time is 2 weeks
overall morbidity which is morbidity from all causes	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	EVD insertion until discharge- estimated period of time is 2 weeks
Mortality	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	EVD insertion until discharge- estimated period of time is 3 weeks

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Investigators: Principal Investigator: David C Altschul, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2021
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: June 25, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Subarachnoid hemorrhage; Hydrocephalus; Intracerebral Hemorrhage; Ventriculitis
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Central Nervous System Viral Diseases; Central Nervous System Infections; Intracranial Hemorrhages; Encephalitis; Neuroinflammatory Diseases; Hemorrhage; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Hydrocephalus; Cerebral Ventriculitis; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Antitubercular Agents; Antimalarials; Anti-Bacterial Agents; Antibiotics, Antitubercular; Doxycycline; Nafcillin
• Other Study ID Numbers: 2021-12680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No