Trachoma Elimination Follow-up - Full Text View

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

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

MedlinePlus related topics: Chlamydia Infections

Drug Information available for: 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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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
Study First Received:	September 14, 2005
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00221364 History of Changes
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:

Bacterial Infections
Corneal Diseases
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Eye Diseases
Eye Infections
Conjunctivitis
Genital Diseases, Male

Conjunctival Diseases
Trachoma
Gram-Negative Bacterial Infections
Genital Diseases, Female
Anti-Bacterial Agents
Azithromycin
Chlamydia Infections
Sexually Transmitted Diseases

Additional relevant MeSH terms:

Bacterial Infections
Anti-Infective Agents
Corneal Diseases
Sexually Transmitted Diseases, Bacterial
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Eye Diseases
Eye Infections
Conjunctivitis
Infection
Genital Diseases, Male

Pharmacologic Actions
Conjunctival Diseases
Trachoma
Gram-Negative Bacterial Infections
Genital Diseases, Female
Anti-Bacterial Agents
Chlamydiaceae Infections
Therapeutic Uses
Azithromycin
Chlamydia Infections
Sexually Transmitted Diseases

ClinicalTrials.gov processed this record on May 06, 2009