Trachoma Elimination Follow-up (TEF)

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 4

Conditions

Chlamydia

Trachoma

Treatments

Drug: Mass treatment with oral azithromycin to an entire village

Study type

Interventional

Funder types

Other

Identifiers

NCT00221364

10-02630

Details and patient eligibility

About

The WHO has initiated a program to eliminate blinding trachoma by the year 2020, in large part by mass oral azithromycin distributions. It is not clear how frequently or for how long these treatments are necessary. Here we assess the frequency and duration of treatment.

Full description

40 villages in the Gurage Zone of Ethiopia were randomly assigned to biannual treatment, annual treatment, and a single treatment. Each treatment consisted of a single dose of oral azithromycin to the entire population over the age of 1 year (when the study was started, azithromycin had not yet been approved for ages below 1 year). We assess the prevalence the ocular chlamydia that causes trachoma in the peak prevalence age of 1-5 years at baseline, and 2, 6, 12, 18, and 24 months post treatment. An extension of the study monitors infection at 30 and 36 months post treatment. Untreated villages from the same area are enrolled in a step-wedge design to assess the presence of a secular trend. A random sample of those not within the 1-5 year old age group are examined to assess the prevalence of infection in the entire community.

Enrollment

20,000 estimated patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 1 to 5 years old in a village in the Gurage zone with endemic trachoma

Exclusion criteria

Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)