Tripartite International Research for the Elimination of Trachoma

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Brief Title

Tripartite International Research for the Elimination of Trachoma

Official Title

Tripartite International Research for the Elimination of Trachoma

Brief Summary

      Mass antimicrobial administrations have been remarkably successful in reducing the prevalence
      of the ocular strains of Chlamydia that cause trachoma. Repeated distributions progressively
      lower the prevalence of infection, and in some cases may even result in local elimination.
      Mass treatments cannot be continued forever, due to concerns about cost and antibiotic
      resistance. The hope has been that other measures such as latrine construction and hygiene
      programs would prevent infection from returning. Unfortunately, no non-antibiotic measure has
      yet demonstrated an effect on infection.

        1. We hypothesize that Chlamydial infection will return to communities when treatment ends.

        2. We hypothesize that infection will be completely eliminated in all communities treated
           for seven years.

        3. We hypothesize that identifying and treating clinically active cases among preschool
           aged children will delay or even prevent reemergence at a far lower cost than mass
           treatment of all individuals.
    

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 continue to
      monitor a sub-set of communities from our TANA study, in Goncha Siso Enese district of East
      Gojam Zone, Ethiopia. Here we evaluate how infection returns when antibiotics are
      discontinued, whether infection can be predictably eliminated, and whether infection can be
      prevented from returning with targeted treatment strategies:

      Specific Aim 1. To determine whether antibiotics can be stopped after 4 years.

      Specific Aim 2. To determine whether infection can be completely eliminated if mass
      treatments continue for seven years.

      Specific Aim 3. To determine whether treatment targeted to pre-school aged children, or to
      households in which a pre-school aged child has clinically active trachoma, will prevent
      infection from returning into the community.

      Specific Aim 4: To determine whether mass azithromycin distributions reduce visits to local
      health clinics due to all causes and infectious causes.

      Specific Aim 5: To determine whether mass azithromycin distributions result in better growth
      metrics (weight-for-height, height-for age, weight-for-age, middle upper arm circumference)
      compared to no treatment.

      Specific Aim 6: To determine whether under-5 mortality is lower in communities treated with
      mass azithromycin compared to no treatment

      Specific Aim 7: To determine whether macrolide resistance in Streptococcus pneumoniae,
      Hameophilus influenzae, and Staphylococcus aureus is more prevalent in communities treated
      with biannual mass azithromycin compared to communities treated with annual mass
      azithromycin, and to determine whether targeted azithromycin treatments result in less
      macrolide resistance compared to mass azithromycin distributions.
    

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 36 months versus 0 months for Aim 1, at 36 months for Aim 2 and 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

Study Arms / Comparison Groups

 J
Description:  Stop Annual 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

29000

Start Date

November 2010

Completion Date

May 2014

Primary Completion Date

November 2013

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

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Tom Lietman, MD, , 

Location Countries

Ethiopia

Location Countries

Ethiopia

Administrative Informations


NCT ID

NCT01202331

Organization ID

10-02169


Responsible Party

Principal Investigator

Study Sponsor

University of California, San Francisco


Study Sponsor

Tom Lietman, MD, Principal Investigator, F.I. Proctor Foundation, UCSF


Verification Date

October 2017