Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMontefiore Medical Center
About this trial
The principal 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). At this time, the duration of prophylactic antibiotic use with antibiotic impregnated EVDs is unknown.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients over the age of 18 years
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Long term (continuous) prophylactic antibiotics
DrugVRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain. 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.
24 hours antibiotics
DrugNafcillin 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Continuous antibiotic use until the EVD is removedExperimental treatment 1 intervention
Group B: Antibiotics for a total of twenty-four hoursExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Cerebrospinal Fluid Positive (CSF+) VRI
A VRI will be defined as an infection of the CNS including abscess (when occurring after EVD placement), ventriculitis, or meningitis. To receive a diagnosis of meningitis or ventriculitis, NHSN criteria (1) OR (2) must be met: 1. Patient has organism(s) identified from CSF by a culture or non-culture based microbiological method (PCR) performed for purposes of clinical diagnosis or treatment OR 2. Patient has 2 or more of: 1. fever (\>38.0°C) or headache 2. meningeal sign(s) 3. cranial nerve sign(s) AND 1 or more of: 4. increased white cells, elevated protein, and decreased glucose in CSF (per reporting lab's reference range) 5. organism(s) seen on Gram stain of CSF 6. organism(s) identified from blood by a culture or non-culture based microbiologic testing method performed for purposes of clinical diagnosis or treatment (not Active Surveillance Culture/Testing) 7. diagnostic single antibody titer (IgM) or 4-fold increase in paired sera (IgG) for organism
Time frame
From EVD insertion until discharge - estimated period of time is 2 weeksSecondary outcomes
1
Class of infecting organism
Class of infecting organisms identified will be summarized by study arm to assess whether the infections that occur in both treatment groups are caused by the same type of pathogen. The class of infecting organism will be summarized by study arm.
Time frame
From EVD insertion until discharge - estimated period of time is 2 weeks2
Time to infection
Time to infection will be assessed from the time of EVD placement until discharge. Results will be summarized by study arm using descriptive statistics.
Time frame
From EVD insertion until discharge - estimated period of time is 2 weeks3
Number of attempts at EVD catheter insertion
The number of attempts to insert the catheter will be evaluated. This outcome will be used to determine any subsequent effect catheter placement may have had on incidence of infection for each treatment modality. The number of placement attempts will be summarized by study arm.
Time frame
From EVD insertion until discharge - estimated period of time is 2 weeks4
Incidence of nosocomial infections
The incidence of nosocomial infections of C. difficile or other multidrug resistant nosocomial infections in participants will be evaluated. Incidence in the context of this study will equal the number of new EVD-related infections divided by the total EVD days at risk and expressed as a percentage. Results will be summarized by study arm using descriptive statistics.
Time frame
From EVD insertion until discharge - estimated period of time is 2 weeksSponsors and contacts
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Source ClinicalTrials.gov