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Childhood Mortality | Mortality Reduction After Oral Azithromycin: Morbidity Study

Childhood Mortality research study

What is the primary objective of this 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 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.

Who is eligible to participate?

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Childhood Mortality

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:AzithromycinBiannual mass oral azithromycin to children

Drug:PlaceboBiannual mass oral placebo to children

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Biannual mass oral azithromycinComparison of childhood infectious and nutritional morbidity in communities randomized to azithromycin versus communities randomized to placebo. Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years Morbidity monitoring: Collect swabs (nasopharyngeal, nasal, conjunctival), blood samples, (thick/thin blood smears, hemoglobin, dried blood spots), and stool samples from 40 randomly selected children aged 1 month to 60 months per community; collect swabs (nasopharyngeal) from 40 randomly selected children aged 7-12 years per community. Anthropometry for all children aged 1 to 60 months per community. Collect nasopharyngeal swabs from all children aged 1-60 months who are seen at a local health clinic and have a respiratory complaint.

Biannual mass oral placeboComparison of childhood infectious and nutritional morbidity in communities randomized to azithromycin versus communities randomized to placebo. Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years Collect swabs (nasopharyngeal, nasal, conjunctival), blood samples, (thick/thin blood smears, hemoglobin, dried blood spots), and stool samples from 40 randomly selected children aged 1 month to 60 months per community; collect swabs (nasopharyngeal) from 40 randomly selected children aged 7-12 years per community Anthropometry for all children aged 1 to 60 months per community Collect nasopharyngeal swabs from all children aged 1-60 months who are seen at a local health clinic and have a respiratory complaint

Study Status

Recruiting

Start Date: November 2014

Completed Date: December 2017

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Presence of malaria parasites on thick blood smear or Rapid Diagnostic Test (RDT) in children 1-60 months

Secondary Outcome: Presence of malaria parasites in children 1-60 months

Study sponsors, principal investigator, and references

Principal Investigator: Tom M Lietman, MD

Lead Sponsor: University of California, San Francisco

Collaborator: Bill and Melinda Gates Foundation

More information:https://clinicaltrials.gov/show/NCT02048007

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