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Trachoma Elimination Follow-up (TEF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00221364
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : July 15, 2015
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Trachoma Chlamydia Drug: Mass treatment with oral azithromycin to an entire village Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Trachoma Elimination With Repeated Mass Azithromycin Treatments
Study Start Date : March 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Primary Outcome Measures :
  1. The prevalence of ocular chlamydia infection in a village as determined by PCR

Secondary Outcome Measures :
  1. Clinical active trachoma, as determined by the WHO simplified grading system, by village

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00221364

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Addis Ababa, Ethiopia
Sponsors and Collaborators
University of California, San Francisco
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Principal Investigator: Thomas M Lietman, MD Proctor Foundation, UCSF

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of California, San Francisco Identifier: NCT00221364    
Other Study ID Numbers: 10-02630
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: July 15, 2015
Last Verified: July 2015
Keywords provided by University of California, San Francisco:
Additional relevant MeSH terms:
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Chlamydia Infections
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Communicable Diseases
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Eye Infections
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Anti-Bacterial Agents
Anti-Infective Agents