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

January 29, 2026 updated by: Montefiore Medical Center

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

The principal 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). At this time, the duration of prophylactic antibiotic use with antibiotic impregnated EVDs is unknown.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intracranial hemorrhage (ICH), which include subarachnoid hemorrhage (SAH), intraparenchymal hemorrhage (IPH) and intraventricular hemorrhage (IVH) affects nearly 30,000 every year in US alone. Despite rapid advances in treatment of just one of these pathologies, SAH, the case fatality rate remains at 32.2% in US. Successful post interventional outcome of patients suffering from SAH depends on the management of a multitude of secondary neurological complications, including prevention of re-hemorrhage, vasospasm, hydrocephalus, increased intracranial pressure (ICP), and seizure. A major component of this care is placement of an external ventricular drain (EVD), which is routine in patients suffering from SAH to manage ICP and to treat hydrocephalus.

Placement of an EVD, however, is not without risk, in particular with regards to infection, commonly referred to as Ventriculostomy Related Infection (VRI). The rate of VRIs has been reported to range widely from 0% to 40% however, with an increased risk in patients suffering from hemorrhage or any vascular diseases (28.6%) in this subgroup, while typically lower (18.5%) in patients suffering from other neurosurgical diagnoses.

Ventriculostomy related infections have been associated with increased delayed cerebral ischemia (a.k.a.; vasospasm), extended hospital duration, increased mortality and higher hospital costs. Despite the importance of management and prevention of VRIs, there hasn't been any clear consensus on administration of antibiotics post-procedurally. This is perpetuated by the fact that each institution, and even providers within institutions, have varying definitions of VRIs, and their own protocols regarding administration of antibiotics.

Although there is an established protocol for insertion of EVD, which include pre-procedural intravenous antibiotic administration, there is no consensus on duration of post-operative antibiotics, despite the fact that successful patient outcomes depend on management of these VRIs.

Further complicating the problem is the growing concern over increasing resistance to gram-positive organisms due to overuse of systemic antibiotics, as well as development of Clostridium difficile infection. As a result, practice is quite variable, based upon individual clinician preferences, rather than evidence based. Determining optimal strategies and protocols to minimize the incidence of VRI, while ensuring responsible antibiotic usage, thereby minimizing their deleterious effects on both individuals and communities, is of chief interest.

These universal concerns and questions deserve a new formal study in this initial feasibility study.

Study Type

Interventional

Enrollment (Estimated)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10452
        • Recruiting
        • Montefiore Medical Center
        • Principal Investigator:
          • David Altschul, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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
  • 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 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Continuous antibiotic use until the EVD is removed
Continuous prophylactic antibiotic use until the EVD is removed. Antibiotics will begin no more than sixty minutes pre-procedure.
Drug: Long term (continuous) prophylactic antibiotics
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. 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.
Experimental: Antibiotics for a total of twenty-four hours
Antibiotics for a total of twenty-four hours. Antibiotics will begin no more than sixty minutes pre-procedure.
Drug: 24 hours antibiotics
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
Number of Participants with Cerebrospinal Fluid Positive (CSF+) VRI
Time Frame: From EVD insertion until discharge - estimated period of time is 2 weeks

A VRI will be defined as an infection of the CNS including abscess (when occurring after EVD placement), ventriculitis, or meningitis. To receive a diagnosis of meningitis or ventriculitis, NHSN criteria (1) OR (2) must be met:

  1. Patient has organism(s) identified from CSF by a culture or non-culture based microbiological method (PCR) performed for purposes of clinical diagnosis or treatment

    OR

  2. Patient has 2 or more of:

    1. fever (>38.0°C) or headache
    2. meningeal sign(s)

    3. cranial nerve sign(s)

      AND 1 or more of:

    4. increased white cells, elevated protein, and decreased glucose in CSF (per reporting lab's reference range)
    5. organism(s) seen on Gram stain of CSF
    6. organism(s) identified from blood by a culture or non-culture based microbiologic testing method performed for purposes of clinical diagnosis or treatment (not Active Surveillance Culture/Testing)
    7. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism
From EVD insertion until discharge - estimated period of time is 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Class of infecting organism
Time Frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Class of infecting organisms identified will be summarized by study arm to assess whether the infections that occur in both treatment groups are caused by the same type of pathogen. The class of infecting organism will be summarized by study arm.
From EVD insertion until discharge - estimated period of time is 2 weeks
Time to infection
Time Frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Time to infection will be assessed from the time of EVD placement until discharge. Results will be summarized by study arm using descriptive statistics.
From EVD insertion until discharge - estimated period of time is 2 weeks
Number of attempts at EVD catheter insertion
Time Frame: From EVD insertion until discharge - estimated period of time is 2 weeks
The number of attempts to insert the catheter will be evaluated. This outcome will be used to determine any subsequent effect catheter placement may have had on incidence of infection for each treatment modality. The number of placement attempts will be summarized by study arm.
From EVD insertion until discharge - estimated period of time is 2 weeks
Incidence of nosocomial infections
Time Frame: From EVD insertion until discharge - estimated period of time is 2 weeks
The incidence of nosocomial infections of C. difficile or other multidrug resistant nosocomial infections in participants will be evaluated. Incidence in the context of this study will equal the number of new EVD-related infections divided by the total EVD days at risk and expressed as a percentage. Results will be summarized by study arm using descriptive statistics.
From EVD insertion until discharge - estimated period of time is 2 weeks
Overall Morbidity
Time Frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Overall morbidity, defined as morbidity from all causes, will be determined. This will include any morbidity from 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), or need for permanent CSF drainage (i.e. ventriculoperitoneal shunt). Morbidity will be summarized by study arm.
From EVD insertion until discharge - estimated period of time is 2 weeks
Overall Mortality
Time Frame: From EVD insertion until discharge - estimated period of time is 2 weeks
Overall mortality, defined as mortality from all causes, will be determined. Mortality along with cause of death will be recorded and summarized for patients who die during the period of insertion of EVD until one week after its removal.
From EVD insertion until discharge - estimated period of time is 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2021

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

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)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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