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
Qualifiers
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
Treatments tested in this trial
- Long term (continuous) prophylactic antibiotics
- 24 hours antibiotics
Treatment groups
84 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov