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NCT01825408 · ClinicalTrials.gov registry record · Phase 4
Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis
A Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT01825408: Completed Phase 4 study, sponsored by University of North Carolina, Chapel Hill.
NCT01825408 is a Phase 4 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01825408, a Phase 4 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the best duration(3 versus 6 weeks) of antibiotics as part of maximal medical therapy for treating chronic sinusitis and thus preventing patients from having to have sinus surgery. The hypothesis is that in the context of maximal medical therapy 3 weeks of antibiotics is not worse than 6 weeks of antibiotics at successfully treating chronic sinusitis.
Primary Outcome
Recommendation for sinus surgery after completion of maximal medical therapy is determined by the subject's treating physician and is based on two citeria: (1) persistence of symptoms and (2) objective evidence of disease on post-treatment sinus CT scan or nasal endoscopy. Symptomatic improvement of sinusitis symptoms will be assessed by: patient self report, change in Chronic Sinusitis Survery (CSS) score and change in RhinoSinusitis Disibility Index (RSDI) score relative to initial pre-antibio
Interventions
- DRUG Azithromycin
- DRUG Doxycycline
- DRUG Augmentin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
What the finished NCT01825408 record still lists
NCT01825408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which Azithromycin is the first listed.
NCT01825408 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01825408 about?
NCT01825408 is a clinical study titled "Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis". The purpose of this study is to determine the best duration(3 versus 6 weeks) of antibiotics as part of maximal medical therapy for treating chronic sinusitis and thus preventing patients from having to have sinus surgery. The hypothesis is that in the context of maximal medical therapy 3 weeks of a...
What is the current status of trial NCT01825408?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2013-02. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01825408?
The interventions under investigation include: Azithromycin (DRUG), Doxycycline (DRUG), Augmentin (DRUG).
Who is sponsoring clinical trial NCT01825408?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01825408's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 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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