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Trachoma Elimination Follow-up

Trachoma Elimination With Repeated Mass Azithromycin Treatments

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00221364
Acronym
TEF
Enrollment
20000
Registered
2005-09-22
Start date
2003-03-31
Completion date
2005-04-30
Last updated
2015-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia, Trachoma

Keywords

Trachoma, Chlamydia, Azithromycin

Brief summary

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.

Detailed 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.

Interventions

DRUGMass treatment with oral azithromycin to an entire village

Sponsors

University of California, San Francisco
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
The prevalence of ocular chlamydia infection in a village as determined by PCR

Secondary

MeasureTime frame
Clinical active trachoma, as determined by the WHO simplified grading system, by village

Countries

Ethiopia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026