Child MortalityREACHNCT04617626
Resiliency Through Azithromycin for Children (REACH), Côte d'Ivoire
A study testing Azithromycin in people with Child Mortality and Azithromycin, run by FHI 360 at 1 site in Côte d’Ivoire.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 5 monthsHealthy volunteers can take part
- Conditions the study is for
- Child Mortality, Azithromycin
- What is being tested?
- Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,735 participants
- Where
- 1 siteCôte d’Ivoire
- Study dates
- 20 Nov 2020to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Côte d’Ivoire1 site
Boundiali Health District
Boundiali, Savanes District
About this study
Official title: REACH Côte d'Ivoire: 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
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:
- Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated
- A cross-sectional, post-MDA coverage survey
- 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.
Read the detailed description
Purpose: 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 d'Ivoire into the existing trachoma MDA platform to inform large scale implementation.
Design: 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:
- Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated
- A cross-sectional, post-MDA coverage survey
- 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.
Population: For expanded use of azithromycin: Infants ages 1 to 5 months who reside in one pilot district in high under-5 years child mortality regions in Côte d'Ivoire (approximately 2,800 to be enrolled).
Post-MDA coverage survey and interviews for acceptability: Parents/primary caregivers of infants aged 1 to 11 months who reside in the two pilot districts will be targeted for the post-MDA coverage survey and in-depth interviews (n=up to 24) to explore acceptability (approximately 275 to be enrolled).
Feasibility and acceptability from implementers' perspectives: Focus group discussions will target community-based drug distributors (CDDs) and in-depth interviews will target CDD supervisors, both to explore operational feasibility. (A maximum of 48 CDDs and 12 CDD supervisors approximately) Pilot Site : Boundiali Health District in Bagoué Region, among the high under-5 child mortality regions in Côte d'Ivoire.
Duration: Planning - 6 months; Training and implementation of the pilot intervention - 3 weeks; Post-MDA research - 1 month; Data analysis and reporting - 2 months.
Objectives: The study is designed to:
- Examine the extent to which activities are carried out as planned (fidelity) during the pilot implementation and the factors that affect the processes and results.
- Estimate coverage of the intervention's target population (1 to 11 month-olds) with azithromycin in pilot districts.
- Assess the level of understanding and acceptability of the strategy among those involved in implementation and among the parents/primary caregivers of children targeted by the intervention.
- Document challenges to implementation and costs of the pilot activity to make recommendations for scale-up.
Endpoints: A final pilot activity report summarizing findings including recommended approaches for scale-up, will be developed after results are shared with the REACH technical working group to inform guidance on scale-up.
- Conditions
- Child Mortality, Azithromycin
- Being tested
- Azithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Single dose of azithromycin suspension
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start20 Nov 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child MortalityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,735 participants (actual)
Sponsor and investigators
- Lead sponsor
- FHI 360
- Sponsor type
- University, hospital or other
- Collaborators
- National Program for the Fight Against Neglected Tropical Diseases, Côte d'Ivoire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617626
- Sponsor's protocol ID
- 1575564
- Acronym
- REACH
- Status last verified
- Jul 2021
- First submitted
- 16 Oct 2020
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from the study survey will be posted to a data sharing site, such as Harvard Dataverse, upon conclusion of the study.
Publications
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.
PubMed 38985785
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACH Côte d'Ivoire: 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
- ClinicalTrials.gov ID
- NCT04617626
- Acronym / sponsor ID
- REACH / 1575564
- Conditions
- Child Mortality, Azithromycin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,735 participants (actual)
- Lead sponsor
- FHI 360University, hospital or other
- Collaborators
- National Program for the Fight Against Neglected Tropical Diseases, Côte d'Ivoire
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 5 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated
- A cross-sectional, post-MDA coverage survey
- 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.
Detailed description
Purpose: 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 d'Ivoire into the existing trachoma MDA platform to inform large scale implementation.
Design: 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:
- Analyses of existing routine monitoring, process, and adverse drug reaction data from the trachoma MDA platform into which the pilot activities are being integrated
- A cross-sectional, post-MDA coverage survey
- 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.
Population: For expanded use of azithromycin: Infants ages 1 to 5 months who reside in one pilot district in high under-5 years child mortality regions in Côte d'Ivoire (approximately 2,800 to be enrolled).
Post-MDA coverage survey and interviews for acceptability: Parents/primary caregivers of infants aged 1 to 11 months who reside in the two pilot districts will be targeted for the post-MDA coverage survey and in-depth interviews (n=up to 24) to explore acceptability (approximately 275 to be enrolled).
Feasibility and acceptability from implementers' perspectives: Focus group discussions will target community-based drug distributors (CDDs) and in-depth interviews will target CDD supervisors, both to explore operational feasibility. (A maximum of 48 CDDs and 12 CDD supervisors approximately) Pilot Site : Boundiali Health District in Bagoué Region, among the high under-5 child mortality regions in Côte d'Ivoire.
Duration: Planning - 6 months; Training and implementation of the pilot intervention - 3 weeks; Post-MDA research - 1 month; Data analysis and reporting - 2 months.
Objectives: The study is designed to:
- Examine the extent to which activities are carried out as planned (fidelity) during the pilot implementation and the factors that affect the processes and results.
- Estimate coverage of the intervention's target population (1 to 11 month-olds) with azithromycin in pilot districts.
- Assess the level of understanding and acceptability of the strategy among those involved in implementation and among the parents/primary caregivers of children targeted by the intervention.
- Document challenges to implementation and costs of the pilot activity to make recommendations for scale-up.
Endpoints: A final pilot activity report summarizing findings including recommended approaches for scale-up, will be developed after results are shared with the REACH technical working group to inform guidance on scale-up.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Other | Drug: AzithromycinAll 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. |
Who may qualify
- Ages
- 1 month to 5 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinSingle dose of azithromycin suspension | Drug | Azithromycin |
Primary outcome
Proportion of children 1 to 11 months reached with single-dose azithromycin
Time frame: 1 week
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Derived from this study: PubMed 38985785Dulli 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.
- Individual participant dataSharing planned: Yes. De-identified data from the study survey will be posted to a data sharing site, such as Harvard Dataverse, upon conclusion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Azithromycin in people with Child Mortality and Azithromycin, run by FHI 360 at 1 site in Côte d’Ivoire.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Côte d’Ivoire. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children 1 to 11 months reached with single-dose azithromycin (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04617626, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.