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NCT05519072 · ClinicalTrials.gov registry record · Phase 4
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA
A Phase 4 study of Antibiotic Prophylaxis, sponsored by Atlantic Health System.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT05519072 is a Phase 4 study of Antibiotic Prophylaxis that is actively recruiting participants, run by Atlantic Health System. The registered enrollment target is 140 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05519072, a Phase 4 study of Antibiotic Prophylaxis, is actively recruiting participants, sponsored by Atlantic Health System.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
This study aims to show that lack of antibiotic prophylaxis to those undergoing bladder Botox injections is not significantly inferior to administering prophylaxis. By proving this, the investigators aim to decrease antibiotic use in this setting to combat the growing issue of antibiotic resistance. Participants will be randomized to antibiotic or no treatment arm. Those randomized to the treatment arm will receive oral antibiotics for 2 days pre-treatment, on the treatment day, and 2 days post-treatment. Participants will return for a follow up appointment approximately 2 weeks after treatment to assess for urinary tract infection (UTI) symptoms. They will be called again at 6 weeks for follow up.
Conditions Studied
Interventions
- DRUG Nitrofurantoin
Study Locations (1)
New Jersey
- Atlantic Health - Morristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2022-08-16 |
| Est. Completion | 2024-08-16 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05519072
The ClinicalTrials.gov registry entry for NCT05519072 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atlantic Health System, which has 43 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Antibiotic Prophylaxis appearing as the primary indexed condition, and to 1 intervention - of which Nitrofurantoin is the first listed.
NCT05519072 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.
Frequently Asked Questions
What is clinical trial NCT05519072 about?
NCT05519072 is a clinical study titled "Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA". This study aims to show that lack of antibiotic prophylaxis to those undergoing bladder Botox injections is not significantly inferior to administering prophylaxis. By proving this, the investigators aim to decrease antibiotic use in this setting to combat the growing issue of antibiotic resistance....
What is the current status of trial NCT05519072?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 140 participants. The study started on 2022-08-16. Estimated completion is 2024-08-16.
What conditions does trial NCT05519072 study?
This clinical trial studies the following conditions: Antibiotic Prophylaxis.
What interventions are being tested in trial NCT05519072?
The interventions under investigation include: Nitrofurantoin (DRUG).
Who is sponsoring clinical trial NCT05519072?
This trial is sponsored by Atlantic Health System, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05519072 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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