Trachoma Elimination Follow-up

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Brief Title

Trachoma Elimination Follow-up

Official Title

Trachoma Elimination With Repeated Mass Azithromycin Treatments

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.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

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

Condition

Trachoma

Intervention

Mass treatment with oral azithromycin to an entire village


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

20000

Start Date

March 2003

Completion Date

April 2005

Primary Completion Date

April 2005

Eligibility Criteria

        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)
      

Gender

All

Ages

1 Year - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas M Lietman, MD, , 

Location Countries

Ethiopia

Location Countries

Ethiopia

Administrative Informations


NCT ID

NCT00221364

Organization ID

10-02630


Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco


Study Sponsor

Thomas M Lietman, MD, Principal Investigator, Proctor Foundation, UCSF


Verification Date

July 2015