Brief Title
Trachoma Amelioration in Northern Amhara (TANA)
Official Title
Eliminating Trachoma With Repeat Mass Drug Treatment
Brief Summary
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.
Detailed 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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
The average prevalence of ocular chlamydia infection in communities in an arm as determined by pooled NAAT (Nucleic Acid Amplification Test)(at 42 months for Aim 1, at 12 months for Aim 2, post-treatment relative to pre-treatment for Aim 3)
Secondary Outcome
Clinical active trachoma in community, as determined by the WHO simplified grading system
Condition
Trachoma
Intervention
Mass treatment with oral azithromycin to an entire community
Study Arms / Comparison Groups
A
Description: Annual mass treatment
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
Drug
Estimated Enrollment
33000
Start Date
June 2006
Completion Date
May 2014
Primary Completion Date
November 2009
Eligibility Criteria
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.
Gender
All
Ages
1 Year - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Tom Lietman, MD, ,
Location Countries
Ethiopia
Location Countries
Ethiopia
Administrative Informations
NCT ID
NCT00322972
Organization ID
10-02576
Responsible Party
Principal Investigator
Study Sponsor
University of California, San Francisco
Study Sponsor
Tom Lietman, MD, Principal Investigator, Proctor Foundation, UCSF
Verification Date
September 2015