Trachoma Amelioration in Northern Amhara (TANA)

University of California San Francisco (UCSF)

Status and phase: Completed; Phase 4

Conditions: Chlamydia; Trachoma

Treatments: Drug: Mass treatment with oral azithromycin to an entire community

Study type: Interventional

Funder types: Other

Identifiers

NCT00322972

10-02576

Details and patient eligibility

About

The WHO has initiated a program to eliminate trachoma, blinding eye infection caused by Chlamydia trachomatis, in large part by mass distributions of oral azithromycin. The proposed study will determine the frequency and treatment target of community-wide mass antibiotic treatment. We will also study the impact of mass antibiotic distribution on antibiotic-resistance in pneumococcus.

Full description

The proposed 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. 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 questions:

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 and the reduction in mortality.

Specific Aim 5. To determine whether annual mass treatments are more likely to eliminate ocular chlamydia from hyper-endemic communities than biennial mass treatments.

Enrollment: 33,000 patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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 exclusion criteria 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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33,000 participants in 6 patient groups

A

Other group

Description:

Annual mass treatment

Treatment:

Drug: Mass treatment with oral azithromycin to an entire community

B

Other group

Description:

Biannual mass treatment

Treatment:

Drug: Mass treatment with oral azithromycin to an entire community

C

Experimental group

Description:

Mass administration of antibiotic; treatment of children (1-10 years of age) only

Treatment:

Drug: Mass treatment with oral azithromycin to an entire community

D

No Intervention group

Description:

Delayed initiation of mass administration of antibiotic

F

Other group

Description:

One-time mass administration only

Treatment:

Drug: Mass treatment with oral azithromycin to an entire community

G

Experimental group

Description:

One-time mass administration of antibiotics, plus intensive latrine construction

Treatment:

Drug: Mass treatment with oral azithromycin to an entire community