NCT05001750 Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
| NCT ID | NCT05001750 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Montefiore Medical Center |
| Condition | Subarachnoid Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2021-06-14 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 84 participants in total. It began in 2021-06-14 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
David C Altschul, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT05001750 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Subarachnoid Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05001750 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05001750 currently recruiting?
Yes, NCT05001750 is actively recruiting participants. Contact the research team at daltschul@montefiore.org for enrollment information.
Where is the NCT05001750 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT05001750 clinical trial?
NCT05001750 is sponsored by Montefiore Medical Center. The principal investigator is David C Altschul, MD at Montefiore Medical Center. The trial plans to enroll 84 participants.