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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Subarachnoid Hemorrhage, Intracerebral Hemorrhage, Ventriculitis, Cerebral, Hydrocephalus

Intervention / Treatment
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* Drug: long term prophylactic antibiotics (Nafcillin or Doxycycline)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: continuous antibiotic use until the EVD is removed<br>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)<br>* 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).<br>* Other names: 24 hours antibiotics;|
| No Intervention: antibiotics for a total of twenty-four hours<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subarachnoid hemorrhage, Intracerebral Hemorrhage, Ventriculitis, Hydrocephalus