Resiliency Through Azithromycin for Children (REACH), Côte d'Ivoire

• Status: Completed
• Trial end date: 2021-01-31
• Target enrollment: 0
• Participant gender: All

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. 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. A cross-sectional, post-MDA coverage survey

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: FHI 360
• Collaborators: Côte d'Ivoire National Program for the Fight Against Neglected Tropical Diseases; National Program for the Fight Against Neglected Tropical Diseases, Côte d'Ivoire
• Treatments: Azithromycin

Criteria

For expanded azithromycin access during the MDA

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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