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

Morality Clinical Trial

— AVENIR  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05288023
• Other study ID #: 19-28387C
• Status: Recruiting
• Phase: Phase 4
• Start date: December 1, 2022
• Est. completion date: March 2027

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: Elodie Lebas
• Phone: 5104232245
• Email: elodie.lebas[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250000
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Month and older

Eligibility

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

Related Conditions & MeSH terms

• Child Health
• Implementation
• Morality
• Resistance Bacterial

Intervention

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.

Locations

Country	Name	City	State
United States	Proctor foundation	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Francisco	Bill and Melinda Gates Foundation, Ministry of Health, Niger

Country where clinical trial is conducted

United States, 

References & Publications (2)

Keenan JD, Bailey RL, West SK, Arzika AM, Hart J, Weaver J, Kalua K, Mrango Z, Ray KJ, Cook C, Lebas E, O'Brien KS, Emerson PM, Porco TC, Lietman TM; MORDOR Study Group. Azithromycin to Reduce Childhood Mortality in Sub-Saharan Africa. N Engl J Med. 2018 Apr 26;378(17):1583-1592. doi: 10.1056/NEJMoa1715474. — View Citation

WHO Guideline on Mass Drug Administration of Azithromycin to Children under Five Years of Age to Promote Child Survival [Internet]. Geneva: World Health Organization; 2020. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK561641/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of genetic determinants of macrolide resistance from population-based samples	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 years
Primary	Load of genetic determinants of macrolide resistance from population-based samples	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).	2 years
Secondary	Prevalence of genetic determinants of macrolide resistance from clinic-based samples	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 years
Secondary	Load of genetic determinants of macrolide resistance from clinic-based samples	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).	2 years
Secondary	Number of all-cause clinic visits	Number of all-cause clinic visits per month for children aged 1-59 months over 1 year	2 years