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

Primary Purpose

Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Ventriculitis, Cerebral

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
long term prophylactic antibiotics (Nafcillin or Doxycycline)
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Subarachnoid Hemorrhage focused on measuring Subarachnoid hemorrhage, Intracerebral Hemorrhage, Ventriculitis, Hydrocephalus

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

continuous antibiotic use until the EVD is removed

antibiotics for a total of twenty-four hours

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Class of infecting organism
assess if the infections that occur in both treatment groups are caused by the same type of pathogen
Time to infection
Evaluate time to infection from time to EVD placement
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
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
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

Full Information

First Posted
June 25, 2021
Last Updated
July 24, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05001750
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)?
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: twenty four hours of prophylactic antibiotic use or 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Ventriculitis, Cerebral, Hydrocephalus
Keywords
Subarachnoid hemorrhage, Intracerebral Hemorrhage, Ventriculitis, Hydrocephalus

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The patients will be randomized into one of two groups, either continuous antibiotic usage until the EVD is removed or antibiotics for a total of twenty-four hours; in both cases antibiotics will begin no more than sixty minutes pre-procedure.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
continuous antibiotic use until the EVD is removed
Arm Type
Experimental
Arm 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.
Arm Title
antibiotics for a total of twenty-four hours
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
long term prophylactic antibiotics (Nafcillin or Doxycycline)
Other Intervention Name(s)
24 hours antibiotics
Intervention Description
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).
Primary Outcome Measure Information:
Title
Ventriculitis extending from EVD insertion until discharge
Description
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)
Time Frame
EVD insertion until discharge- estimated period of time is 2 weeks
Secondary Outcome Measure Information:
Title
Class of infecting organism
Description
assess if the infections that occur in both treatment groups are caused by the same type of pathogen
Time Frame
EVD insertion until discharge- estimated period of time is 2 weeks
Title
Time to infection
Description
Evaluate time to infection from time to EVD placement
Time Frame
EVD insertion until discharge- estimated period of time is 2 weeks
Title
Incidence of nosocomial infections
Description
incidence of C. difficile or multidrug resistant nosocomial infections in participants especially those who are on a longer course of antibiotics
Time Frame
EVD insertion until discharge- estimated period of time is 2 weeks
Title
overall morbidity which is morbidity from all causes
Description
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
Time Frame
EVD insertion until discharge- estimated period of time is 2 weeks
Title
Mortality
Description
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
Time Frame
EVD insertion until discharge- estimated period of time is 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David C Altschul, MD
Phone
7189204965
Email
daltschul@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Erida C Rivas
Phone
7189204965
Email
ecastroriv@montefiore.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David C Altschul, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical center
City
Bronx
State/Province
New York
ZIP/Postal Code
10452
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erida Castro Rivas, MS
Phone
718-920-4965
Email
ecastroriv@montefiore.org
First Name & Middle Initial & Last Name & Degree
Lavinia C Williams
Phone
7189204965
Email
ecastroriv@montefiore.org
First Name & Middle Initial & Last Name & Degree
David Altschul, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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