Trachoma Elimination Follow-up - Tabular View

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

April 1, 2008

Start Date ^ICMJE

March 2003

Estimated Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00221364 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Trachoma Elimination Follow-up

Official Title ^ICMJE

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 IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Trachoma
Chlamydia

Intervention ^ICMJE

Drug: Mass treatment with oral azithromycin to an entire village

Study Arms / Comparison Groups

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 ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

20000

Estimated Completion Date

April 2005

Estimated Primary Completion Date

April 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

1 Year and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Ethiopia

Administrative Information

NCT ID ^ICMJE

NCT00221364

Responsible Party

Thomas Lietman, MD, Proctor Foundation

Study ID Numbers ^ICMJE

TEF

Study Sponsor ^ICMJE

University of California, San Francisco

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Thomas M Lietman, MD

Proctor Foundation, UCSF

Information Provided By

University of California, San Francisco

Verification Date

April 2008

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