Malaria Clinical Trial
— Toto BoraOfficial title:
Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children
Verified date | November 2023 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Children hospitalized with severe illness in sub-Saharan Africa are at high risk of morbidity and mortality following discharge from hospital. These children represent an accessible high-risk population in which targeted interventions to prevent morbidity and mortality could have dramatic impact. A large cluster randomized trial of azithromycin delivered in a mass drug administration program within trachoma endemic areas in sub-Saharan Africa demonstrated an almost 50% mortality benefit in children 1-9 years of age in treated communities. However, mass drug administration of azithromycin leads to the rapid emergence of macrolide resistance within treated communities and is expensive. The targeted delivery of azithromycin to children at hospital discharge may be a novel and practical intervention to maximize benefit while minimizing risk of antibiotic resistance. This is a randomized, double-blind, placebo-controlled trial to determine the efficacy of azithromycin provided at discharge, compared to placebo, in reducing mortality and re-hospitalization rates in children age 1-59 months in Kenya. The study will also investigate potential mechanisms by which azithromycin may reduce morbidity and mortality in this population and will assess the emergence of antibiotic resistance among treated individuals and their primary caregivers. A cost-effectiveness analysis of the intervention will also be conducted.
Status | Active, not recruiting |
Enrollment | 1400 |
Est. completion date | December 28, 2025 |
Est. primary completion date | May 4, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Month to 59 Months |
Eligibility | Inclusion Criteria: - Age 1-59 months, - Plan to remain in study area greater than 6 months - Discharged from hospital following non-trauma related admission Exclusion Criteria: - Contraindication to azithromycin use and other prophylactic antibiotic use |
Country | Name | City | State |
---|---|---|---|
Kenya | Kisii Teaching and Referral Hospital, Homa Bay District Hospital, St. Paul's Mission Hospital | Kisii And Homa Bay Counties |
Lead Sponsor | Collaborator |
---|---|
University of Washington | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Kenya Medical Research Institute |
Kenya,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Re-hospitalization or Death | Incidence rate of a composite outcome of mortality and hospital readmission during the 6 month post-discharge (follow-up) period. | 6 months | |
Secondary | Mean Change in Length for Age Z-score (LAZ) Between Baseline and Outcome Assessment | Mean change in length for age z-score (LAZ) between baseline and M3 or M6 | 6 months | |
Secondary | The Number of Children With Diarrhea Re-hospitalizations Following Randomization | The number of children with diarrhea re-hospitalizations following randomization through follow-up | 6 months | |
Secondary | The Number of Children With Acute Respiratory Illness Re-hospitalizations Following Randomization | 6 months | ||
Secondary | The Number of Children With Malnutrition Re-hospitalizations Following Randomization | 6 months | ||
Secondary | The Number of Children With Malaria Re-hospitalizations Following Randomization | 6 months | ||
Secondary | Prevalence of Enteric Pathogen Carriage | Prevalence of enteric bacteria, viruses, and protozoa identified by qPCR at 3 months of follow-up | 3 months | |
Secondary | Prevalence of Streptococcus Pneumoniae Carriage | Prevalence of Streptococcus pneumoniae from nasopharyngeal swabs collected at M3 and M6 follow-up timepoints. | 6 months | |
Secondary | Number of Participants With Escherichia Coli Isolates From Fecal Samples Resistant to Azithromycin | Among participants with E.coli isolated, # of participants with aizhtromycin resistance detected in E.coli form disc diffusion. | 6 months (E.coli isolated at baseline, month 3, and month 6) | |
Secondary | Proportion of Beta-lactam or Macrolide Resistance in Strep Pneumo in Children and Caregivers | 6 months |
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