Impact of Two Alternative Dosing Strategies for Trachoma Control in Niger
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,139
- 试验地点
- 2
- 主要终点
- Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]
研究概览
简要总结
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.
详细描述
Population
We will take advantage of the ongoing work in the ten villages currently being studied in Kornaka West. They have never had mass treatment with azithromycin, and the baseline trachoma and infection rates are greater than 20%. The final survey for that current study will occur in January, 2008. Within villages, we will use the updated complete village census lists generated in the January 2008 survey. The children for that survey were randomly selected from the baseline census to provide a sample of approximately 50-60 children in the village ages 0 to five years. They are now a cohort of children ages 2 to 7 years. We propose to add approximately 15 children ages 0-2 from the updated census list for a total of 65-70 children per village.
Sample
We propose to re-randomize the villages, stratified by baseline trachoma rates and former intervention, into treatment intervention (2 rounds of mass treatment) and control (one round of mass treatment) arms. The villages will be balanced by baseline trachoma rates and the original randomization to water and sanitation interventions. Within villages, we propose to use the same sample of children ages 2-7 years and add a random sample of 15 children ages 0 to 2 years.
It will also be important to determine the effect of the two mass drug administration arms on infection in adults, so we propose to randomly select one adult from each household where there is an index child. If the adult is out of the village at the time of the survey, then the next randomly assigned adult will be selected for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible to participate in this study the subject must live in one of the villages selected for this study.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Azithromcyin (Drug)
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.
干预措施: Azithromycin (Drug)
结局指标
主要结局
Infection With Chlamydia Trachomatis Diagnosed by Use of NAATs [Nucleic Acid Amplification Test]
时间窗: 1-year post-treatment
次要结局
未报告次要终点