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Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR) (AVENIR)

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ClinicalTrials.gov Identifier: NCT05288023
Recruitment Status : Not yet recruiting
First Posted : March 18, 2022
Last Update Posted : September 7, 2022
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Ministry of Health, Niger
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE February 23, 2022
First Posted Date  ICMJE March 18, 2022
Last Update Posted Date September 7, 2022
Estimated Study Start Date  ICMJE December 1, 2022
Estimated Primary Completion Date March 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 29, 2022)
  • Prevalence of genetic determinants of macrolide resistance from population-based samples [ Time Frame: 1 year ]
    Prevalence of genetic determinants of macrolide resistance including those determinants known to be found in Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus in nasopharyngeal swabs in children aged 1-59 months from population-based samples after 1 year of distribution
  • Load of genetic determinants of macrolide resistance from population-based samples [ Time Frame: 1 year ]
    Load of genetic determinants of resistance to macrolides including those determinants known to be found in Campylobacter spp, Salmonella spp, Shigella spp, and Escherichia coli from rectal swabs in children 1-59 months old from population-based samples, defined as read number per million base pairs, using DNA-seq (metagenomic deep sequencing).
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2022)
  • Infant mortality rate [ Time Frame: 2 years ]
    Infant mortality rate (deaths per 1,000 live births)
  • Number of total and cause-specific clinic visits [ Time Frame: 1 year from the first distribution of azithromycin ]
    Number of total and cause-specific clinic visits for diarrhea, respiratory infection, and malaria among children aged 1-59 months visiting local health center clinics
  • Prevalence of genetic determinants of macrolide resistance [ Time Frame: 1 year ]
    Prevalence of genetic determinants for macrolide resistance in nasopharyngeal swabs in children aged 1-59 months
  • Load of genetic determinants of macrolide resistance [ Time Frame: 1 year ]
    Load of genetic determinants of macrolide resistance in rectal swabs among children aged 1-59 months
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 29, 2022)
  • Prevalence of genetic determinants of macrolide resistance from clinic-based samples [ Time Frame: 1 year ]
    Prevalence of resistance to macrolides including those determinants known to be found in Streptococcus pneumoniae, Streptococcus pyogenes, and Staphylococcus aureus from nasopharyngeal swabs in children 1-59 months old.
  • Load of genetic determinants of macrolide resistance from clinic-based samples [ Time Frame: 1 year ]
    Load of genetic determinants of resistance to macrolides including those determinants known to be found in Campylobacter spp, Salmonella spp, Shigella spp, and Escherichia coli from rectal swabs in children 1-59 months old, defined as read number per million base pairs, using DNA-seq (metagenomic deep sequencing).
  • Number of all-cause clinic visits [ Time Frame: 1 year ]
    Number of all-cause clinic visits per month for children aged 1-59 months over 1 year
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2022)
Program costs [ Time Frame: 1 year ]
Program costs as captured by routine administrative data collection during the study period and by micro-costing activities
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Azithromycin for Child Survival in Niger: Programmatic Trial (AVENIR)
Official Title  ICMJE Azithromycine Pour la Vie Des Enfants au Niger - Implémentation et Recherche: Essai mortalité et résistance (Azithromycin for Child Survival in Niger: Programmatic Trial)
Brief Summary The MORDOR trial found that biannual distribution of azithromycin to children 1-59 months old reduced child mortality. The World Health Organization (WHO) released conditional guidelines for this intervention, which include targeting azithromycin distributions to children 1-11 months of age in high mortality settings. The proposed trial aims to demonstrate and evaluate large-scale implementation of azithromycin to children aged 1-11 months old in the context of a programmatic setting while monitoring mortality and resistance antimicrobial resistance.
Detailed Description

In the Programmatic Trial, community health centers (also known as "CSIs" or "Centres de Santé Intégrés") will be randomized to one of two arms: 1) programmatic azithro 1-11: biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers or 2) no intervention: no distribution of azithromycin. A total of 2,490 communities within selected CSIs will be included .

All communities in both arms receive routine health services offered by community health workers working for the Niger Ministry of Health's community health program.

Mortality will be monitored through birth histories. Mortality and morbidity will also be monitored using routinely collected community and clinic visit data. Antimicrobial resistance will be monitored in a subset of eligible CSIs.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cluster-randomized trial with response adaptive allocation
Masking: None (Open Label)
Masking Description:
Participants, investigators, and program implementers will not be actively masked from the study arm allocation given that no placebo will be used. Outcome assessors and data analysts will be masked.
Primary Purpose: Treatment
Condition  ICMJE
  • Resistance Bacterial
  • Morality
  • Child Health
  • Implementation
Intervention  ICMJE Drug: Azithromycin for Oral Suspension

Azithromycin will be administered as a single dose in oral suspension form for children (up to the maximum adult dose of 1g).

Dosage will be calculated by age for children aged 1-5 months. For children 6-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program.

Other Name: Zithromax
Study Arms  ICMJE
  • Active Comparator: Programmatic azithro 1-11
    Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers
    Intervention: Drug: Azithromycin for Oral Suspension
  • No Intervention: no intervention
    No additional intervention.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2022)
250000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2026
Estimated Primary Completion Date March 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Intervention

At the community-level, eligibility includes:

Inclusion Criteria:

  • Location in Dosso, Tahoua, Maradi, Zinder, or Tillabéri regions
  • Distinguishable from neighboring communities
  • Verbal consent of community leader(s)

Exclusion criteria:

  • Inaccessible or unsafe for study team
  • "Quartier" designation on national census

At the individual-level, eligibility includes:

Inclusion criteria:

  • Age 1-11 months
  • Primary residence in a study community
  • Verbal consent of caregiver/guardian for study participation

Exclusion criteria:

  • Known allergy to macrolides

Population-based sample collections

At the community-level, eligibility includes:

Inclusion criteria:

  • Location in study region
  • Distinguishable from neighboring communities
  • Verbal consent of community leader(s)

Exclusion criteria:

  • Inaccessible or unsafe for study team
  • Included in MORDOR trials
  • Not randomly selected

At the individual-level, eligibility includes:

Inclusion criteria:

  • Age 1-59 months or 7-12 years or caregiver/guardian of a child eligible for treatment
  • Primary residence in a study community selected for sample collections
  • Verbal consent of caregiver/guardian for study participation

Exclusion criteria:

  • Not on list of randomly selected participants from the census
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elodie Lebas 5104232245 elodie.lebas@ucsf.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05288023
Other Study ID Numbers  ICMJE 19-28387C
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: De-identified data underlying outcomes publications will be made publicly available.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Time Frame: Individual participant data will be made available after publication of the outcomes and will be made available indefinitely.
Access Criteria: Once made available, the data will be open access.
Current Responsible Party University of California, San Francisco
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of California, San Francisco
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Bill and Melinda Gates Foundation
  • Ministry of Health, Niger
Investigators  ICMJE
Principal Investigator: Kieran O'Brien, PhD, MPH University of California, San Francisco
Principal Investigator: Tom Lietman, MD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP