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NCT05001750 · ClinicalTrials.gov registry record · Phase 1
Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?
A Phase 1 study of Intracerebral Hemorrhage and Subarachnoid Hemorrhage, sponsored by Montefiore Medical Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT05001750: Recruiting Phase 1 study of Intracerebral Hemorrhage and Subarachnoid Hemorrhage, sponsored by Montefiore Medical Center.
NCT05001750 is a Phase 1 study of Intracerebral Hemorrhage and Subarachnoid Hemorrhage that is actively recruiting participants, run by Montefiore Medical Center. The registered enrollment target is 84 participants, below the 1,103-participant average among 31 other Intracerebral Hemorrhage trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05001750, a Phase 1 study of Intracerebral Hemorrhage and Subarachnoid Hemorrhage, is actively recruiting participants, sponsored by Montefiore Medical Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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. c
Conditions Studied
Interventions
- DRUG Long term (continuous) prophylactic antibiotics
- DRUG 24 hours antibiotics
Study Locations (1)
New York
- Montefiore Medical Center - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2026-06 |
| Phase | Phase 1 |
What NCT05001750 shows while recruiting
NCT05001750 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 1,103-participant average among 31 other Intracerebral Hemorrhage trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Intracerebral Hemorrhage appearing as the primary indexed condition, and to 2 interventions - of which Long term (continuous) prophylactic antibiotics is the first listed.
NCT05001750 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05001750 about?
NCT05001750 is a clinical study titled "Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular Drains (EVDs)?". 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...
What is the current status of trial NCT05001750?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2021-06-14. Estimated completion is 2026-06.
What conditions does trial NCT05001750 study?
This clinical trial studies the following conditions: Intracerebral Hemorrhage, Subarachnoid Hemorrhage, Hydrocephalus, Ventriculitis, Cerebral.
What interventions are being tested in trial NCT05001750?
The interventions under investigation include: Long term (continuous) prophylactic antibiotics (DRUG), 24 hours antibiotics (DRUG).
Who is sponsoring clinical trial NCT05001750?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05001750 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05001750's enrollment target sits among peer trials
84 23rd of 31 higher than 9 of 31 other Intracerebral Hemorrhage trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intracerebral Hemorrhage trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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