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NCT00031499 · ClinicalTrials.gov registry record · Phase 3
Azithromycin/Bicillin Syphilis
A Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 3
- Development phase
- 593
- Enrollment target
NCT00031499: Completed Phase 3 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00031499 is a Phase 3 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 593 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00031499, a Phase 3 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 593 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if azithromycin, a drug approved for treatment of other infections, is as effective for syphilis (a sexually transmitted disease) as the standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55 years of age, with primary, secondary or early latent syphilis, will participate in this research study. Volunteers will be enrolled in 5 U.S. cities and in Madagascar. Participants will be chosen randomly (by chance) to receive 1 of 2 study drugs: benzathine penicillin given (2 shots in the buttocks) or 4 tablets of azithromycin. Subjects who report a history of a penicillin allergy will be given either 2.0 g of oral azithromycin or 100 mg doxycycline taken orally, twice a day for 14 days. Over 2 years, 10 visits will be required. Procedures will include blood samples, physical exams, and swabs of sores.
Interventions
- DRUG Azithromycin
- DRUG Doxycycline
- DRUG Benzathine Penicillin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 593 participants |
| Start Date | 2000-06 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00031499 record still lists
NCT00031499 is an interventional study that assigns participants to a tested intervention. The registered 593 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Azithromycin is the first listed.
NCT00031499 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00031499 about?
NCT00031499 is a clinical study titled "Azithromycin/Bicillin Syphilis". The purpose of this study is to determine if azithromycin, a drug approved for treatment of other infections, is as effective for syphilis (a sexually transmitted disease) as the standard treatment. Approximately 600 healthy adults, who are HIV-negative, ages 18 to 55 years of age, with primary, sec...
What is the current status of trial NCT00031499?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 593 participants. The study started on 2000-06. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00031499?
The interventions under investigation include: Azithromycin (DRUG), Doxycycline (DRUG), Benzathine Penicillin (DRUG).
Who is sponsoring clinical trial NCT00031499?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00031499's enrollment target sits among peer trials
593 643rd of 2000 higher than 1,358 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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