Trachoma Amelioration in Northern Amhara (TANA)

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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