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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Resistance Bacterial Morality Child Health Implementation Drug: Azithromycin for Oral Suspension Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250000 participants
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
Official Title: Azithromycine Pour la Vie Des Enfants au Niger - Implémentation et Recherche: Essai mortalité et résistance (Azithromycin for Child Survival in Niger: Programmatic Trial)
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Programmatic azithro 1-11
Biannual oral azithromycin administration to children aged 1-11 months distributed by community health workers
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

No Intervention: no intervention
No additional intervention.



Primary Outcome Measures :
  1. 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

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT05288023


Contacts
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Contact: Elodie Lebas 5104232245 elodie.lebas@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
Bill and Melinda Gates Foundation
Ministry of Health, Niger
Investigators
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Principal Investigator: Kieran O'Brien, PhD, MPH University of California, San Francisco
Principal Investigator: Tom Lietman, MD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05288023    
Other Study ID Numbers: 19-28387C
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: September 7, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data underlying outcomes publications will be made publicly available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
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.

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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
Additional relevant MeSH terms:
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Azithromycin
Anti-Bacterial Agents
Anti-Infective Agents