Azithromycin/Bicillin Syphilis

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Azithromycin; Doxycycline; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillins

Criteria

Inclusion Criteria:

• The subject is 18 to 55 years of age.

• The subject has signed written informed consent.

• The subject has untreated primary [darkfield or Treponema (T.) pallidum by a rapid, direct, fluorescent antibody darkfield (DFA-TP)] positive genital ulcers, secondary (based on classical palmar/plantar rash, condylomata lata, mucous patches, etc. or darkfield or DFA-TP positive lesions), or early latent syphilis (e.g., current reactive serologic tests for syphilis (STS), and a documented non-reactive STS or documented sexual exposure to a known early latent, primary or secondary syphilis patient in last 12 months; identification of this sexual contact must occur within 60 days of admission into the study).

• The subject has laboratory evidence of syphilis, i.e., reactive serologic test for syphilis (RPR).

• The subject is not pregnant, as documented by a negative urine or serum pregnancy test, or lactating.

• The subject is willing to have an HIV test, and, participate in HIV counseling and return to the clinic for follow-up treatment.

Exclusion Criteria:

• The subject does not have reactive serologic tests for syphilis.

• The subject has latent syphilis of unknown duration, late latent syphilis or evidence of neurosyphilis.

• The subject has a known or suspected allergy to macrolide or azalide antibiotics.

• The subject has a known or suspected sexually transmitted disease (STD), other than syphilis requiring treatment with a drug, other than azithromycin, active against T. pallidum.

• The subject has used antibiotics active against T. pallidum in the preceding 30 days. (Note: the use of antimicrobials known to NOT be effective against T. pallidum such as quinolones, sulfonamides, trimethoprim, metronidazole and spectinomycin will be allowed).

• The subject is known to be HIV positive prior to enrollment.

• The subject has suspected or known ongoing drug use that might interfere with study participation and follow-up treatment.

• The subject has a history of cardiovascular disease, known immunosuppression, or known AIDS, which might compromise response to therapy.

• The subject is judged by the investigators to be unlikely to reliably participate in the study follow-up.

• The subject has used any investigational drugs in the past 30 days.

• The subject has any other condition that may impair drug absorption (malabsorption syndrome or active peptic ulcer disease).