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

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Brief Title

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

Official Title

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

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 Phase

Phase 1

Study Type

Interventional


Primary Outcome

Ventriculitis extending from EVD insertion until discharge

Secondary Outcome

 Class of infecting organism

Condition

Subarachnoid Hemorrhage

Intervention

long term prophylactic antibiotics (Nafcillin or Doxycycline)

Study Arms / Comparison Groups

 continuous antibiotic use until the EVD is removed
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

150

Start Date

June 14, 2021

Completion Date

July 14, 2023

Primary Completion Date

June 14, 2023

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05001750

Organization ID

2021-12680


Responsible Party

Principal Investigator

Study Sponsor

Montefiore Medical Center


Study Sponsor

, , 


Verification Date

May 2022