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

Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05001750
• Other study ID #: 2021-12680
• Status: Recruiting
• Phase: Phase 1
• Start date: June 14, 2021
• Est. completion date: June 2024

Study information

• Verified date: July 2023
• Source: Montefiore Medical Center
• Contact: David C Altschul, MD
• Phone: 7189204965
• Email: daltschul[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Cerebral Ventriculitis
• Hemorrhage
• Hydrocephalus
• Intracerebral Hemorrhage
• Subarachnoid Hemorrhage
• Ventriculitis, Cerebral

Intervention

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).

Locations

Country	Name	City	State
United States	Montefiore Medical center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Time to infection	Evaluate time to infection from time to EVD placement	EVD insertion until discharge- estimated period of time is 2 weeks
Secondary	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
Secondary	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
Secondary	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