Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00618449
First received: February 6, 2008
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Trachoma
Chlamydia Trachomatis
Drug: Azithromcyin
Drug: Azithromycin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test] [ Time Frame: 1-year post-treatment ] [ Designated as safety issue: No ]

Enrollment: 1139
Study Start Date: January 2008
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 2
Subjects residing in villages assigned to treatment arm 2 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0), as well as receive an initial treatment with 1 gm oral dose of Azithromycin; receive a second 1 gm oral dose of Azithromycin at Day 30; be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.
Drug: Azithromcyin
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.
Active Comparator: Arm 1
Subjects residing in villages assigned to treatment arm 1 will receive a clinical evaluation for trachoma and provide a swab specimen of conjunctivae of the R eye at enrollment (Day 0); be treated at Day 30 with the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin; be re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60 and Day 360.
Drug: Azithromycin
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618449

Locations
United States, California
Chlamydia Research Laboratory
San Francisco, California, United States, 94110
Niger
Programme National de Lutte Contre la Cécité
Niamey, Niger
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Julius Schachter, PhD University of California, San Francisco
Study Director: Abdou Amza, MD Programme National de Lutte Contre la Cécité
  More Information

Additional Information:
Publications:
Dawson CR, Jones BR, Tarizzo ML. A Guide to Trachoma Control. Geneva: World Health Organization; 1981.

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00618449     History of Changes
Other Study ID Numbers: H1079-31932, 5R01AI048789
Study First Received: February 6, 2008
Results First Received: January 27, 2011
Last Updated: April 10, 2012
Health Authority: United States: Institutional Review Board
Niger: Institutional Review Board

Keywords provided by University of California, San Francisco:
Trachoma
Chlamydia trachomatis

Additional relevant MeSH terms:
Trachoma
Bacterial Infections
Chlamydia Infections
Chlamydiaceae Infections
Conjunctival Diseases
Conjunctivitis
Conjunctivitis, Bacterial
Corneal Diseases
Eye Diseases
Eye Infections
Eye Infections, Bacterial
Gram-Negative Bacterial Infections
Infection

ClinicalTrials.gov processed this record on November 25, 2014