Randomised controlled trial of single-dose azithromycin in treatment of trachoma

Lancet. 1993 Aug 21;342(8869):453-6. doi: 10.1016/0140-6736(93)91591-9.


Blindness due to trachoma is a serious public health issue world wide. The currently recommended treatment of active trachoma with repeated doses of tetracycline eye ointment has many disadvantages. The new azalide antibiotic azithromycin is effective as a single oral dose in the chemotherapy of genital Chlamydia trachomatis infections, and we have assessed its efficacy for trachoma treatment. We carried out a randomised single-blind comparison of azithromycin (a single oral dose of 20 mg/kg) with conventional treatment (6 weeks of topical tetracycline plus erythromycin for severe cases) in two villages with endemic trachoma in The Gambia. The patients were followed up for 26 weeks from the start of treatment by an observer unaware of treatment allocation. By 6 months' follow-up, trachoma had resolved in 76 (78%) of 97 subjects who received azithromycin compared with 70 (72%) of 97 who were treated conventionally (95% CI for difference -6% to 18%). Compliance with both treatments was good, but that for conventional treatment could probably not be achieved outside the research setting. There were no significant differences in treatment effect, baseline characteristics, or re-emergent disease between the treatment groups. Azithromycin was well tolerated. As a systemic treatment effective in a single dose it has important potential for trachoma control.

PIP: Azithromycin is effective against Chlamydia trachomatis in vitro and as a single dose for the treatment of chlamydia infection of the genital tract. A randomized single-blind study was conducted in 2 Gambian villages (Jali with a population of 900 and Berending with 500) in order to assess the effectiveness and safety of a single oral dose of 20 mg/kg azithromycin compared with conventional treatment in ocular C. trachomatis infection. In May 1992 an ocular survey was done in both villages, and 199 subjects with active trachoma were identified (128 in Jali and 71 in Berending). Of these, 194 patients were randomly assigned to conventional or azithromycin treatment. Azithromycin was administered in a single dose of 20 mg/kg. Subjects receiving conventional treatment were given 1% tetracycline eye ointment to each eye twice daily for 6 weeks. Severe cases were given oral erythromycin stearate based on an adult dose of 250 mg 4 times daily for 2 weeks. Subjects were examined 4, 8, 16, and 26 weeks after treatment. In 20% of the subjects diarrhea, vomiting, and abdominal pain occurred. Clinical signs had resolved by 6 months' follow-up in 146 patients: 70 (72%) in the conventional treatment group, and 76 (78%) in the azithromycin group. At 6 months the symptoms of 9 subjects with severe disease, and 21 with moderate disease had resolved. However, during follow-up, 11 of those with severe disease, 30 of those with moderate disease, and 129 of those with mild disease had resolution at some point, which reflects the scale of re-emergent disease. To allow for the effect of recrudescent disease on point prevalences at follow-up, a survival analysis of time to loss of clinical signs as outcome was done. There was no difference between treatments (p 0.9). 21 of the 194 subjects were antigen positive in their nasal secretions at baseline. Of these, 18 still had clinical signs at 4 weeks compared with 87 of the 173 with antigen-negative nasal secretions ( p = 0.004; odds ratio 5.93).

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Antigens, Bacterial / analysis
  • Azithromycin
  • Child
  • Child, Preschool
  • Chlamydia trachomatis / immunology
  • Erythromycin / administration & dosage
  • Erythromycin / adverse effects
  • Erythromycin / analogs & derivatives*
  • Erythromycin / therapeutic use
  • Female
  • Follow-Up Studies
  • Humans
  • Infant
  • Male
  • Middle Aged
  • Ointments
  • Patient Compliance
  • Recurrence
  • Single-Blind Method
  • Tetracycline / administration & dosage
  • Tetracycline / adverse effects
  • Tetracycline / therapeutic use
  • Trachoma / drug therapy*
  • Trachoma / microbiology


  • Antigens, Bacterial
  • Ointments
  • Erythromycin
  • Azithromycin
  • Tetracycline