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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Trachoma Elimination With Repeated Mass Azithromycin Treatments

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

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

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

Estimated Enrollment: 20000
Study Start Date: March 2003
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221364

Locations
Ethiopia
ORBIS-Ethiopia
Addis Ababa, Ethiopia
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Thomas M Lietman, MD Proctor Foundation, UCSF
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00221364     History of Changes
Other Study ID Numbers: 10-02630
Study First Received: September 14, 2005
Last Updated: June 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Trachoma
Chlamydia
Azithromycin

Additional relevant MeSH terms:
Chlamydia Infections
Trachoma
Chlamydiaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Sexually Transmitted Diseases, Bacterial
Sexually Transmitted Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female
Conjunctivitis, Bacterial
Eye Infections, Bacterial
Eye Infections
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014