Azithromycin/Bicillin Syphilis

Completed · Phase 3

Conditions studied: Syphilis

In brief

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.

Key facts

Study ID

NCT00031499

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

593

Starts

2000-06-01

Expected to finish

2009-03-01

Last updated by the study team

2013-04-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• University of Alabama Hospital - Infectious Diseases — Birmingham, Alabama, United States
• Indiana University — Indianapolis, Indiana, United States
• Louisiana State University Health Sciences Center - Infectious Diseases — New Orleans, Louisiana, United States
• Johns Hopkins Hospital - Medicine - Infectious Diseases — Baltimore, Maryland, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• University of North Carolina School of Medicine - Center for Infectious Diseases — Chapel Hill, North Carolina, United States
• Durham County Health Department — Durham, North Carolina, United States
• Laboratoire National de Reference sur le VIH/SIDA (LNR) — Analamanga, Antananarivo, Madagascar
• Hopitaly Kely — Toamasina, Antsiranana, Madagascar
• Hopitaly Mahabibo — Mahajanga Majunga, Mahajanga, Madagascar

Full record on ClinicalTrials.gov

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