NCT04617626

Brief Summary

The aim of the study is to gather preliminary evidence on the operational feasibility and acceptability of integrating bi-annual mass drug administration (MDA) of single-dose azithromycin for children ages 1 to 11 months in high child mortality settings in Côte. The cross-sectional study will be carried out in conjunction with a single trachoma MDA in selected villages within one health district. Data on feasibility and acceptability will be collected through three main activities:

  1. 1.Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated
  2. 2.A cross-sectional, post-MDA coverage survey
  3. 3.Qualitative data collection among targeting parents or primary caregivers of children ages 1 to 11 months in the pilot districts, and district-level MDA implementers, regarding the proposed azithromycin program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,735

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
15 days until next milestone

Study Start

First participant enrolled

November 20, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

October 16, 2020

Last Update Submit

July 14, 2021

Conditions

Child MortalityAzithromycin

Outcome Measures

Primary Outcomes (1)

  • Proportion of children 1 to 11 months reached with single-dose azithromycin

    The proportion of children 1 to 11 months of age who receive a single dose of azithromycin during the MDA in the target health district.

    1 week

Study Arms (1)

Azithromycin

OTHER

All children ages 1 to 5 months in the targeted health district will be offered a single dose of azithromycin suspension dosed at 20 mg per kg of weight in place of the standard tetracycline ointment, during a mass drug administration targeting trachoma prevention and treatment. All children ages 6 months and older, and all adults already receive the single dose of azithromycin during the MDA event. For this pilot study, single dose of azithromycin is being extended to include the 1 to 5 month old population as well.

Drug: Azithromycin

Interventions

AzithromycinDRUG

Single dose of azithromycin suspension

Azithromycin

Eligibility Criteria

Age1 Month - 5 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child aged 1 month (at least 30 days) to less than 6 months at the beginning of the week of the MDA intervention
  • Resident in study communities

You may not qualify if:

  • Children below 3.0 kg
  • Appears severely ill at the time of the MDA (per the CDD's assessment)
  • Unable to swallow liquid delivered through a needle-less syringe because of physical limitations
  • Known allergy to macrolides, including azithromycin, based on the primary caregiver's report of prior adverse reaction to medication likely to be a macrolide

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boundiali Health District

Boundiali, Savanes District, Côte d’Ivoire

Location

Related Publications (1)

  • Dulli L, Toure F, Mama AD, Evens E, Murray K, Dje NN, Kone S, Sadate-Ngatchou P, Bovary A, Eichleay M, Jean-Baptiste M, Meite A. Feasibility and acceptability of integrating mass distribution of azithromycin to children 1-11 months into a trachoma mass drug administration campaign to reduce child mortality in Cote d'Ivoire. PLOS Glob Public Health. 2024 Jul 10;4(7):e0003426. doi: 10.1371/journal.pgph.0003426. eCollection 2024.

    PMID: 38985785DERIVED

MeSH Terms

Interventions

Azithromycin

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2020

First Posted

November 5, 2020

Study Start

November 20, 2020

Primary Completion

January 31, 2021

Study Completion

January 31, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

De-identified data from the study survey will be posted to a data sharing site, such as Harvard Dataverse, upon conclusion of the study.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
To be made available indefinitely after Feb. 28, 2020.

Locations

CÔ(1)