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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 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00031499
The ClinicalTrials.gov registry entry for NCT00031499 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 593 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Azithromycin is the first listed.
NCT00031499 reports 0 study locations.
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.
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