Subarachnoid Hemorrhage Clinical Trial
Official title:
Are Long Term Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
NCT number | NCT05001750 |
Other study ID # | 2021-12680 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 1 |
First received | |
Last updated | |
Start date | June 14, 2021 |
Est. completion date | June 2024 |
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
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 |
Country | Name | City | State |
---|---|---|---|
United States | Montefiore Medical center | Bronx | New York |
Lead Sponsor | Collaborator |
---|---|
Montefiore Medical Center |
United States,
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 |
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