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|ClinicalTrials.gov Identifier: NCT00031499|
Recruitment Status : Completed
First Posted : March 7, 2002
Last Update Posted : April 29, 2013
|Condition or disease||Intervention/treatment||Phase|
|Syphilis||Drug: Azithromycin Drug: Benzathine Penicillin Drug: Doxycycline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||593 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Equivalence Trial of Azithromycin vs. Benzathine Penicillin for the Treatment of Early Syphilis|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||March 2009|
Azithromycin 2.0 gram single oral dose.
Single 2 gram oral dose (4 tablets) at Day 1.
Active Comparator: Benzathine Penicillin
Benzathine penicillin 2.4 million units administered intramuscularly. Doxycycline will be administered if the patient is allergic to Benzathine Penicillin.
Drug: Benzathine Penicillin
Supplied in pre-filled syringes containing 1.2 million units of benzathine penicillin; 2.4 million units administered intramuscularly at Day 1, in one or both buttocks.
Baseline visit, 28 capsules dispensed, for a dose of 100 mg twice a day (BID).
- Cure of syphilis defined as a negative reactive serologic test for syphilis (RPR) titer or greater than or equal to a 4-fold (2 dilution) decrease in RPR titer at 6 months following treatment and resolution of all signs and symptoms of syphilis. [ Time Frame: Month 6. ]
- Cure rates at 9, 12 and 24 months post treatment and the rate of relapse or reinfection defined as cure followed by recurrent clinical manifestations or a 2-dilution increase in RPR titer over previous lowest result. [ Time Frame: Months 9, 12, and 24. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00031499
|United States, Alabama|
|University of Alabama Hospital - Infectious Diseases|
|Birmingham, Alabama, United States, 35249-0001|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|United States, Louisiana|
|Louisiana State University Health Sciences Center - Infectious Diseases|
|New Orleans, Louisiana, United States, 70112-2865|
|United States, Maryland|
|Johns Hopkins Hospital - Medicine - Infectious Diseases|
|Baltimore, Maryland, United States, 21287-0005|
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27514|
|University of North Carolina School of Medicine - Center for Infectious Diseases|
|Chapel Hill, North Carolina, United States, 27599-7030|
|Durham County Health Department|
|Durham, North Carolina, United States, 27701-3720|
|Laboratoire National de Reference sur le VIH/SIDA (LNR)|
|Analamanga, Antananarivo, Madagascar, 101|
|Tamatave, Antsiranana, Madagascar|
|Mahajanga Majunga, Mahajanga, Madagascar, 401|