Eliminating Trachoma with Repeat Mass Drug Treatment (TANA)

Purpose:

To determine the frequency and treatment target of community-wide mass antibiotic treatment to eliminate trachoma.
To study the impact of mass antibiotic distribution on antibiotic-resistance in pneumococcus and on the prevalence of malaria.

Background:

Trachoma is one of the leading causes of visual loss, accounting for 10-15% of world blindness. Although it disappeared long ago from western Europe and the United States, trachoma is still endemic in some parts of Africa, the Middle East, Australia, and Southeast Asia. Ocular strains of Chlamydia trachomatis cause repeated episodes of conjunctivitis in children. In teenagers and adults, the disease progresses through a cascade of conjunctival scarring, in-turned eyelids (entropion), lashes touching the eye (trichiasis), and finally blinding corneal ulceration from bacterial or fungal super-infection of the abraded cornea.

The current rationale of the World Health Organization's trachoma control strategy is to eliminate chlamydial infection in large part with mass antibiotic treatment. The common wisdom is that everyone in the community should be treated, as at present it is not possible to accurately identify those infected with Chlamydia trachomatis, the bacterium that causes trachoma. Following a community-wide antibiotic treatment for trachoma, chlamydial infection recurs, and it is not currently known how frequently repeat treatments should be given in order to successfully reduce, or even eliminate infection from the community.

Description:

The study is a group-randomized trial to determine the frequency and treatment target of community-wide mass antibiotic treatment to eliminate trachoma. We will also study the impact of community-wide antibiotic distribution on antibiotic-resistance in pneumococcus and on the prevalence of malaria. Communities in Goncha Siso Enese district of East Gojam Zone, Ethiopia will be randomly assigned to different treatment schemes and monitored to study the following research aims:

Specific Aim 1. To determine whether biannual mass treatments is more likely to eliminate ocular chlamydia from hyper-endemic communities than annual mass treatments.

Specific Aim 2. To determine whether children form a core group for the transmission of trachoma.

Specific Aim 3. To determine whether latrine construction prevents the return of infection into a community after mass treatment.

Specific Aim 4. To determine the effect of mass azithromycin treatments on antibiotic resistance in pneumococcus, the prevalence of malaria and the consequent reduction in mortality.

Patient Eligibility:

Inclusion Criteria:

All residents residing in the state-teams which are randomly selected for this study.

Pregnant women
Children under 6 months of age
All those who are allergic to macrolides or azalides
Refusal of village chief (for village inclusion), or refusal of parent or guardian (for individual inclusion)

Individuals in these three categories will not be given the study antibiotic azithromycin, but offered the current WHO-recommended alternative treatment to azithromycin for active trachoma, which is 1% tetracycline eye ointment, to be used twice a day, topically to both eyes, for six weeks. Note that the exclusion criteria refer to the exclusion to the treatment drug, but not to the monitoring, treatment of trachoma, and examinations.

Patient Recruitment Status:

Not yet recruiting. Comments: No one has been recruited yet for the study.

Current Status of Study:

Ongoing. Comments: Proctor Foundation expects to begin this study in May 2006, pending approval from the Ethiopian and UCSF Institutional Review Boards.

Results:

None at this time.

Publications

None

Clinical Centers

derejehabte@yahoo.com

NEI Representative

dfe@nei.nih.gov

Resource Centers

Collaborating Institution

pemerso@emory.edu

http://www.emory.edu/

Study Chair

tom.lietman@ucsf.edu

Last Updated: 9/7/2006

U. S. Department of Health and Human Services

National Institutes of Health