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Randomized Controlled Trial Clinical Trial
Effectiveness of syphilis treatment using azithromycin and/or benzathine penicillin in Rakai, Uganda.
- Mohammed G Kiddugavu, Noah Kiwanuka, Maria J Wawer, David Serwadda, Nelson K Sewankambo, Fred Wabwire-Mangen, Fredrick Makumbi, Xianbin Li, Steven J Reynolds, Thomas C Quinn, Ronald H Gray, and Rakai Study Group.
- Rakai Health Science Program, Uganda Virus Research Institute, Entebbe, Uganda.
- Sex Transm Dis. 2005 Jan 1;32(1):1-6.
ObjectiveThe goal of this study was to assess azithromycin and/or benzathine penicillin for treatment of syphilis.MethodsIn a population-based study, participants with serologic syphilis (TRUST with TPHA confirmation) were offered 2.4 MU benzathine penicillin intramuscularly. Intervention arm participants received 1 g presumptive oral azithromycin. We assessed cure rates with penicillin or azithromycin given alone and in combination. Cure assessed after 10 months was defined as seroreversion or a 4-fold decrease in titer. The rate ratio (RR) of cure and 95% confidence intervals (95% CIs) were estimated by log binomial regression.ResultsAmong 952 cases with syphilis, 18% received penicillin alone, 17% azithromycin only, and 65% dual treatment. The overall cure rate was 61%. Cure rates were lower in males compared with females (RR, 0.89; 95% CI, 0.80-0.99) and in subjects with initial titers > or =1:4 compared with < or =1:2 (RR, 0.77; 95% CI, 0.69-0.86). There was no significant differences in cure rates among HIV-positive and HIV-negative persons. With initial titers < or =1:2, there were no differences in cure rates by treatment regimen. However, with initial titers > or =1:4, significantly higher cure rates were observed with azithromycin alone (adjusted RR, 1.38; 95% CI, 0.97-1.96), and with dual treatment of azithromycin and benzathine penicillin (RR, 1.38; 95% CI, 1.03-1.87) compared with penicillin alone.ConclusionAzithromycin alone or in combination with penicillin achieved higher cure rates than penicillin alone in cases with a high initial TRUST titer. In low-titer infections, the 3 drug combinations were equally effective. HIV status did not affect cure rates.
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