Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
Condition: Trachoma; Chlamydia Trachomatis
MeSH terms: Chlamydia Infections; Trachoma
Intervention: Azithromcyin; Azithromycin
Intervention description: 1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given 30 days apart; at Day 0 & Day 30 for a total of 2 doses.; 1 gm Azithromycin orally, provided as four 250 mg tablets for adults; pediatric suspension will be provided to children > 1 year old (20 mg/kg body weight) to a maximal dose of 500 mg - Given at Day 30 for a total of 1 dose.
Intervention MeSH terms: Azithromycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 1139.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Trachoma; Chlamydia trachomatis

Summary:

      Trachoma is a disease of poverty, which in the hyperendemic areas affects all individuals by
      the time they are two years old. Active disease is concentrated in children and occurs
      sporadically in adults. Infection is more widespread. It is anticipated that 25% of the
      children will be blinded by this disease if they live to be 60 years of age. The blindness
      rates are higher in women, presumably because of their closer contact with children who can
      infect them and add to damage from infections the women had while young.

      This proposal is to better define how azithromycin in community-based treatment can be used
      to eliminate blinding trachoma. We will also take the opportunity to join these field studies
      with genetic epidemiologic studies to better understand the dynamic epidemiology of Chlamydia
      trachomatis infection in a trachoma endemic area. The empiric data generated from the
      treatment/follow-up studies, together with the information on sources and spread patterns
      from genetic epidemiology will be used to generate more robust models to guide future
      treatment/re-treatment protocols.

      We propose to conduct a randomized, community based trial in the Maradi region of Niger to
      test the hypothesis that two community wide azithromycin treatments, spaced one month apart,
      are significantly more effective in reducing ocular C. trachomatis infection and trachoma at
      one year compared to a single mass azithromycin treatment.
    

Eligibility criteria:

        Subjects live in a village in Niger that exhibits a high prevalence of clinically active
        trachoma (>15%) amongst the children living in that village. This prevalence of clinical
        disease is a marker for much higher infection rates, thus justifying community wide
        treatment.

        Inclusion Criteria:

          -  To be eligible to participate in this study the subject must live in one of the
             villages selected for this study.

        Exclusion Criteria:

          -  All subjects meeting any of the exclusion criteria will be excluded from study
             participation. Exclusion criteria include:

               -  history of allergy to ANY macrolide antibiotic

               -  severe nausea or diarrhea after the first dose of azithromycin

               -  inability to tolerate oral therapy

               -  pre-existing serious illness