Mortality Reduction After Oral Azithromycin: Morbidity Study
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/2/2018 |
| Start Date: | November 2014 |
| End Date: | December 2019 |
Evaluating Impact of Azithromycin Mass Drug Administrations on All-cause Mortality and Antibiotic Resistance: Morbidity Study
The long-term goal of this study is to more precisely define the role of mass azithromycin
treatments as an intervention for reducing childhood morbidity and increasing growth, and for
the potential selection of antibiotic resistance. The investigators propose a set of 3
cluster-randomized trials in Malawi, Niger, and Tanzania comparing communities randomized to
oral azithromycin with those randomized to placebo. To assess the generalizability of the
intervention, investigators will monitor for antibiotic resistance, which could potentially
limit adoption of mass antibiotic treatments. The investigators will also assess several
measures of infectious diseases. The investigators hypothesize that mass azithromycin
treatments will reduce childhood morbidity and will be accompanied by an acceptable level of
antibiotic resistance.
treatments as an intervention for reducing childhood morbidity and increasing growth, and for
the potential selection of antibiotic resistance. The investigators propose a set of 3
cluster-randomized trials in Malawi, Niger, and Tanzania comparing communities randomized to
oral azithromycin with those randomized to placebo. To assess the generalizability of the
intervention, investigators will monitor for antibiotic resistance, which could potentially
limit adoption of mass antibiotic treatments. The investigators will also assess several
measures of infectious diseases. The investigators hypothesize that mass azithromycin
treatments will reduce childhood morbidity and will be accompanied by an acceptable level of
antibiotic resistance.
The investigators will assess childhood infectious disease morbidity and macrolide resistance
over two years, comparing communities where children aged 1-60 months receive biannual oral
azithromycin to communities where the children receive biannual oral placebo.
Randomization of Treatment Allocation. In each site, 30 communities within a contiguous area
of 300,000 to 600,000 individuals will be randomized into the azithromycin or placebo arm.
The investigators will use a simple random sample separately for each study site, but without
stratification or block randomization within the site. These communities are being randomized
from the same pool of communities eligible for a sister trial (Mortality Reduction After Oral
Azithromycin (MORDOR) - Morbidity Study).
Specific Aims
Specific Aim 1: To assess whether macrolide resistance is greater in a population-based
community sample of pre-school children, or in a clinic-based sample of ill pre-school
children
Specific Aim 2: To assess whether biannual mass azithromycin treatments of pre-school
children can eliminate ocular chlamydia in a hypoendemic area
Specific Aim 3: To assess the diversity of the microbiome of the nasopharynx, nares,
conjunctiva, and gastrointestinal tract
over two years, comparing communities where children aged 1-60 months receive biannual oral
azithromycin to communities where the children receive biannual oral placebo.
Randomization of Treatment Allocation. In each site, 30 communities within a contiguous area
of 300,000 to 600,000 individuals will be randomized into the azithromycin or placebo arm.
The investigators will use a simple random sample separately for each study site, but without
stratification or block randomization within the site. These communities are being randomized
from the same pool of communities eligible for a sister trial (Mortality Reduction After Oral
Azithromycin (MORDOR) - Morbidity Study).
Specific Aims
Specific Aim 1: To assess whether macrolide resistance is greater in a population-based
community sample of pre-school children, or in a clinic-based sample of ill pre-school
children
Specific Aim 2: To assess whether biannual mass azithromycin treatments of pre-school
children can eliminate ocular chlamydia in a hypoendemic area
Specific Aim 3: To assess the diversity of the microbiome of the nasopharynx, nares,
conjunctiva, and gastrointestinal tract
Inclusion Criteria:
Communities:
- The community location in target district.
- The community leader consents to participation in the trial
- The community's estimated population is between 200-2,000 people.
- The community is not in an urban area.
Individuals (Intervention):
- Children-treated arms (all 3 sites): All children aged 1-60 months (up to but not
including the 5th birthday), as assessed at the most recent biannual census
Individuals (Examination & Sample Collection):
- All swabs, blood tests, and stool samples: A random sample of children aged 1-60
months (up to but not including the 5th birthday) based on the previous census
- Anthropometric measurements: All children aged 1-60 months (up to but not including
the 5th birthday) will have anthropometric measurements assessed.
- Nasopharyngeal swabs in untreated children: A random sample of individuals aged 7 - 12
years (7th birthday up to but not including the 12th birthday), as assessed from the
previous census
- Clinic-based nasopharyngeal swabs: All children aged 1-60 months (up to but not
including the 5th birthday) who present to a local health clinic in the study area and
report symptoms of a respiratory infection
Exclusion Criteria:
Individuals:
- Pregnant women
- 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)
We found this trial at
3
sites
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