Trachoma Elimination Follow-up - Full Text View

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 IV

Genetics Home Reference related topics:

Eye Diseases

MedlinePlus related topics:

Chlamydia Infections

ChemIDplus related topics:

Azithromycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Dose Comparison, Single Group Assignment, Efficacy Study

Official Title:	Trachoma Elimination With Repeated Mass Azithromycin Treatments

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
Estimated Study Completion Date:	April 2005
Estimated 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

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:

Melese M, Chidambaram JD, Alemayehu W, Lee DC, Yi EH, Cevallos V, Zhou Z, Donnellan C, Saidel M, Whitcher JP, Gaynor BD, Lietman TM. Feasibility of eliminating ocular Chlamydia trachomatis with repeat mass antibiotic treatments. JAMA. 2004 Aug 11;292(6):721-5.

Chidambaram JD, Melese M, Alemayehu W, Yi E, Prabriputaloong T, Lee DC, Cevallos V, Zhou Z, Whitcher JP, Gaynor BD, Lietman TM. Mass antibiotic treatment and community protection in trachoma control programs. Clin Infect Dis. 2004 Nov 1;39(9):e95-7. Epub 2004 Oct 6.

Ray KJ, Porco TC, Hong KC, Lee DC, Alemayehu W, Melese M, Lakew T, Yi E, House J, Chidambaram JD, Whitcher JP, Gaynor BD, Lietman TM. A rationale for continuing mass antibiotic distributions for trachoma. BMC Infect Dis. 2007 Aug 7;7:91.

Lee S, Alemayehu W, Melese M, Lakew T, Lee D, Yi E, Cevallos V, Donnellan C, Zhou Z, Chidambaram JD, Gaynor BD, Whitcher JP, Lietman TM. Chlamydia on children and flies after mass antibiotic treatment for trachoma. Am J Trop Med Hyg. 2007 Jan;76(1):129-31.

Chidambaram JD, Alemayehu W, Melese M, Lakew T, Yi E, House J, Cevallos V, Zhou Z, Maxey K, Lee DC, Shapiro BL, Srinivasan M, Porco T, Whitcher JP, Gaynor BD, Lietman TM. Effect of a single mass antibiotic distribution on the prevalence of infectious trachoma. JAMA. 2006 Mar 8;295(10):1142-6.

Publications indexed to this study:

Melese M, Alemayehu W, Lakew T, Yi E, House J, Chidambaram JD, Zhou Z, Cevallos V, Ray K, Hong KC, Porco TC, Phan I, Zaidi A, Gaynor BD, Whitcher JP, Lietman TM. Comparison of annual and biannual mass antibiotic administration for elimination of infectious trachoma. JAMA. 2008 Feb 20;299(7):778-84.

Responsible Party:	Proctor Foundation ( Thomas Lietman, MD )
Study ID Numbers:	TEF
First Received:	September 14, 2005
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00221364
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

Trachoma

Chlamydia

Azithromycin

Study placed in the following topic categories:

Corneal Diseases

Eye Infections, Bacterial

Conjunctivitis, Bacterial

Azithromycin

Eye Infections

Sexually Transmitted Diseases

Chlamydia Infections

Conjunctivitis

Conjunctival Diseases

Gram-Negative Bacterial Infections

Trachoma

Additional relevant MeSH terms:

Genital Diseases, Female

Bacterial Infections

Anti-Infective Agents

Anti-Bacterial Agents

Sexually Transmitted Diseases, Bacterial

Chlamydiaceae Infections

Therapeutic Uses

Eye Diseases

Genital Diseases, Male

Infection

Pharmacologic Actions

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00221364