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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: Recruiting Phase 4 study of Antibiotic Prophylaxis, sponsored by Atlantic Health System.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with urinary tract infections
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 |
What NCT05519072 shows while recruiting
NCT05519072 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05519072's enrollment target sits among peer trials
140 581st of 2000 higher than 1,409 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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