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This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a single dose to women who have genital chlamydial infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rifalazil 25 milligram | Experimental |
| |
| Azithromycin 1 gram | Active Comparator | Single dose of Azithromycin 1 gram to be administered on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifalazil 25 milligram | Drug | Single dose of 25 milligram rifalazil to be administered on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 22 | Microbiologic test result will be reported as positive or negative for chlamydia trachomatis. | Day 22 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with microbiologic cure of chlamydia trachomatis infection at Day 36. | Microbiologic test result will be reported as positive or negative for chlamydia trachomatis. | Day 36 |
| Number of subjects experiencing adverse events in the two treatment groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chalom B Sayada, MD, PhD | ActivBiotics Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | 35294 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24798277 | Derived | Geisler WM, Pascual ML, Mathew J, Koltun WD, Morgan F, Batteiger BE, Mayes A, Tao S, Hurwitz SJ, Sayada C, Schinazi RF. Randomized, double-blind, multicenter safety and efficacy study of rifalazil compared with azithromycin for treatment of uncomplicated genital Chlamydia trachomatis infection in women. Antimicrob Agents Chemother. 2014 Jul;58(7):4014-9. doi: 10.1128/AAC.02521-14. Epub 2014 May 5. |
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| Azithromycin 1 gram | Drug | Single dose of Azithromycin 1 gram to be administered on Day 1. |
|
|
| Day 36 (end of study) |
| Number of subjects experiencing clinically significant laboratory abnormalities in the two treatment groups. | Day 36 (end of study) |
| San Diego |
| California |
| 92108 |
| United States |
| Research Site | Indianapolis | Indiana | 46202 | United States |
| Research Site | Las Vegas | Nevada | 89106 | United States |
| Research Site | Virginia Beach | Virginia | 23456 | United States |
| ID | Term |
|---|---|
| D002690 | Chlamydia Infections |
| ID | Term |
|---|---|
| D002694 | Chlamydiaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C068980 | KRM 1648 |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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