Trachoma Elimination Follow-up (TEF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00221364
First received: September 14, 2005
Last updated: June 4, 2013
Last verified: June 2013

September 14, 2005
June 4, 2013
March 2003
April 2005   (final data collection date for primary outcome measure)
The prevalence of ocular chlamydia infection in a village as determined by PCR
Same as current
Complete list of historical versions of study NCT00221364 on ClinicalTrials.gov Archive Site
Clinical active trachoma, as determined by the WHO simplified grading system, by village
Same as current
Not Provided
Not Provided
 
Trachoma Elimination Follow-up
Trachoma Elimination With Repeated Mass Azithromycin Treatments

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
  • Trachoma
  • Chlamydia
Drug: Mass treatment with oral azithromycin to an entire village
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20000
April 2005
April 2005   (final data collection date for primary outcome measure)

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)

Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
Ethiopia
 
NCT00221364
10-02630
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Thomas M Lietman, MD Proctor Foundation, UCSF
University of California, San Francisco
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP