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Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children (Toto Bora)

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ClinicalTrials.gov Identifier: NCT02414399
Recruitment Status : Recruiting
First Posted : April 10, 2015
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
Kenya Medical Research Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Judd Walson, University of Washington

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pneumonia Diarrhea Malaria Co-infection Death Malnutrition Drug: Azithromycin Drug: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Azithromycin to Prevent Post-discharge Morbidity and Mortality in Kenyan Children
Actual Study Start Date : June 28, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Azithromycin
Azithromycin 10mg/kg for one day, then 5mg/kg for four days, a total of five days of experimental treatment.
Drug: Azithromycin
oral administration of Azithromycin
Other Names:
  • Zithromax
  • Zmax

Placebo Comparator: Placebo
5 days of taste/appearance/bottle-matched placebo
Drug: Placebo
5 days of taste/appearance/bottle-matched inactive substance




Primary Outcome Measures :
  1. Composite outcome of mortality and hospital readmission [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Mean change in length for age z-score (LAZ) between baseline and outcome assessment [ Time Frame: 6 months ]
  2. The number of children with diarrhea re-hospitalizations following randomization [ Time Frame: 6 months ]
  3. The number of children with acute respiratory illness re-hospitalizations following randomization [ Time Frame: 6 months ]
  4. The number of children with malnutrition re-hospitalizations following randomization [ Time Frame: 6 months ]
  5. The number of children with malaria re-hospitalizations following randomization [ Time Frame: 6 months ]
  6. Prevalence of enteric pathogen carriage [ Time Frame: 6 months ]
  7. Prevalence of Streptococcus pneumoniae carriage [ Time Frame: 6 months ]
  8. Mean Enteric Inflammation Composite Score (Myeloperoxidase, Neopterin, Alpha-anti-trypsin) [ Time Frame: 6 months ]
  9. Proportion of beta-lactam or macrolide resistance or both [ Time Frame: 6 months ]
  10. Mean fecal calprotectin levels [ Time Frame: 6 months ]


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Ages Eligible for Study:   1 Month to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02414399


Contacts
Contact: Judd L Walson, MD, MPH 206-744-3695 ext 43695 walson@uw.edu
Contact: Patricia B Pavlinac, PhD, MS 206-616-8326 ppav@uw.edu

Locations
Kenya
Kisii Teaching and Referral Hospital, Homa Bay District Hospital, St. Paul's Mission Hospital Recruiting
Kisii And Homa Bay Counties, Kenya
Contact: Benson Singa, MBChB, MPH       singabo2008@gmail.com   
Sponsors and Collaborators
University of Washington
Kenya Medical Research Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Judd L Walson, MD, MPH University of Washington Department of Global Health
Study Director: Patricia B Pavlinac, PhD, MS University of Washington Department of Global Health

Publications:

Responsible Party: Judd Walson, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02414399     History of Changes
Other Study ID Numbers: STUDY00002592
R01HD079695 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: June 19, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Judd Walson, University of Washington:
post-discharge mortality
morbidity and mortality prevention
azithromycin
linear growth

Additional relevant MeSH terms:
Pneumonia
Diarrhea
Malnutrition
Coinfection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Nutrition Disorders
Infection
Virus Diseases
Parasitic Diseases