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Completed

NCT Number: NCT00221364

Trachoma Elimination Follow-up

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.

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Key information

Conditions

Trachoma Bacterial Infections Bacterial Infections and Mycoses Chlamydia Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Conjunctival Diseases Conjunctivitis Conjunctivitis, Bacterial Corneal Diseases Eye Diseases Eye Infections Eye Infections, Bacterial Genital Diseases Gram-Negative Bacterial Infections Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

ORBIS-Ethiopia

Addis Ababa, Ethiopia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Mass treatment with oral azithromycin to an entire village

Drug

Primary outcomes

  1. The prevalence of ocular chlamydia infection in a village as determined by PCR

Secondary outcomes

  1. Clinical active trachoma, as determined by the WHO simplified grading system, by village

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Trachoma Elimination With Repeated Mass Azithromycin Treatments

Acronym: TEF

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 22, 2005
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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