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Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger

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ClinicalTrials.gov Identifier: NCT00618449
Recruitment Status : Completed
First Posted : February 20, 2008
Results First Posted : May 8, 2012
Last Update Posted : May 8, 2012
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.


Condition or disease Intervention/treatment Phase
Trachoma Chlamydia Trachomatis Drug: Azithromcyin Drug: Azithromycin Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
Study Start Date : January 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test] [ Time Frame: 1-year post-treatment ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Julius Schachter, PhD University of California, San Francisco
Study Director: Abdou Amza, MD Programme National de Lutte Contre la Cécité

Additional Information:
Publications:
Dawson CR, Jones BR, Tarizzo ML. A Guide to Trachoma Control. Geneva: World Health Organization; 1981.
World Health Organization. Future Approaches to Trachoma Control. Report of a global scientific meeting. 17 - 20 June 1996.

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00618449     History of Changes
Other Study ID Numbers: H1079-31932
5R01AI048789 ( U.S. NIH Grant/Contract )
First Posted: February 20, 2008    Key Record Dates
Results First Posted: May 8, 2012
Last Update Posted: May 8, 2012
Last Verified: April 2012

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

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