Azithromycin/Bicillin Syphilis
Condition: Syphilis
MeSH terms: Syphilis
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Syphilis is a disease with a worldwide distribution. It causes genital ulceration, thereby
      amplifying risk for HIV acquisition and transmission and it may cause congenital infection,
      spontaneous abortion, and stillbirth if untreated in pregnant women. About one third of all
      cases, if untreated, result in late sequelae which include neurosyphilis, gumma formation and
      cardiovascular involvement. This study will be a multi-center, randomized, open-label trial
      to evaluate the efficacy of azithromycin in treating primary, secondary and early latent
      syphilis in HIV (Human Immunodeficiency Virus) uninfected volunteers. Up through version 6.0
      of this protocol volunteers were only followed for 12 months. The protocol was amended
      starting with version 7.0 to include follow-up visits at month 18 and 24 in order to capture
      possible "late failures." Each subject will be randomized into a treatment group. If the
      subject does not have a self-reported history of penicillin allergy, the subject will be
      randomized to receive either a single 2.0 gram dose of azithromycin administered orally, or
      2.4 million units of benzathine penicillin G administered intramuscularly once. Eligible
      patients who report a history of penicillin allergy will be randomized (using a separate
      randomization schedule) to receive either a single dose of azithromycin or doxycycline, 100
      milligrams, taken orally, twice a day for 14 days. Block randomization will be used within
      each clinical center with subjects allocated in equal numbers to either standard therapy or
      azithromycin. Participants found to be ineligible for study participation after they have
      been randomized and treated, will be treated again with benzathine penicillin G (or
      doxycycline if they are allergic to penicillin) and will continue follow-up for safety
      evaluation. The treatment assignments will not be blinded. No attempt will be made to recruit
      a sufficient sample size among penicillin allergic subjects to attain the desired power for
      the primary outcome. Therefore these results will be seen as preliminary to a possible future
      trial and as confirmatory to the primary comparison. Although the study endpoint will be
      determined at 6 months, all participants, will have follow-up visits for 2 full years. At the
      end of the 6 month evaluation period, all participants will have been classified in one of
      the following groups: cure; clinical response/serological nonresponse; or failure.
    

Intervention name(s): Azithromycin; Benzathine Penicillin; Doxycycline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single 2 gram oral dose (4 tablets) at Day 1.; 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).
Intervention MeSH terms: Azithromycin; Doxycycline; Penicillins; Penicillin G Benzathine; Penicillin G; Penicillin G Procaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Azithromycin, Syphilis, Penicillin