The Relapse to Acute Malnutrition Prevention (RAMP) Trial

ConditionsAcute Malnutrition in Childhood Acute Malnutrition, Severe

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-59

SponsorAction Against Hunger USA

About this trial

This individually randomized controlled trial uses a 2x2 factorial design to evaluate the effects of azithromycin and small-quantity lipid-based nutrient supplements (SQ-LNS) on sustained nutritional recovery following initial recovery from uncomplicated severe acute malnutrition (SAM) in South Sudan. The study will evaluate the effects of each intervention component alone and when given together, compared with standard care, on sustained recovery for 12 months post initial SAM recovery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 6-44 months

Diagnosed with uncomplicated SAM (MUAC < 11.5 cm and/or WHZ < -3 SD and/or bilateral pitting edema)

Being admitted to an outpatient therapeutic program (OTP) at one of the outpatient treatment sites where the study is conducted

Residing in the catchment area of a study OTP site with no plans to move elsewhere for the next 15 months.

Disqualifiers

Age below 6 months or above 44 months

Signs of severe illness requiring hospitalization

Hospitalized prior to OTP admission (including in a stabilization center)

Prior treatment for acute malnutrition within three months preceding study enrollment

Trial design

Design model

Factorial

Treatments tested in this trial

Azithromycin
Drug
A single oral dose of 20mg/kg azithromycin will be administered under direct observation to children once every four weeks (with four weeks equaling one month of clinic services) for six monthly visits. It will be supplied as a 200 mg/5mL oral suspension reconstituted on-site and dosed using a calibrated dosing cup.
Placebo (Azithromycin)
Drug
A single oral dose of matched placebo suspension equivalent to a 20mg/kg azithromycin dose will be administered under direct observation to children once every four weeks (with four weeks equaling one month of clinic services) at six monthly visits. It will be supplied as a 200 mg/5mL matched oral suspension reconstituted on-site and dosed using a calibrated dosing cup.
Small-quantity Lipid-based Nutrient Supplements
Dietary supplement
One 20g sachet of SQ-LNS (120 kcal) will be provided daily consumption by children. It will be dispensed to caregivers as a monthly supply of 28 sachets at six monthly visits. (Four weeks equals one month of clinic services.) Open label.

Treatment groups

3,750 Participants

are divided into 4 treatment groups

Group A: ControlActive comparator 1 intervention

Group B: RAMP Experimental AExperimental treatment 1 intervention

Group C: RAMP Experimental BExperimental treatment 2 interventions

Group D: RAMP Experimental CExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Sustained nutritional recovery at 12 months post-recovery

Proportion of children who remained alive and achieved sustained nutritional recovery, defined as WHZ ≥ -2, MUAC ≥ 125mm, and no edema throughout the 12 months post-discharge.

Time frame

Up to 12 months post-discharge

Secondary outcomes

Sustained recovery at 6 months

Proportion of children who achieve sustained recovery at the end of the six-month intervention period.

Time frame

6 months post-discharge.

Cumulative incidence of relapse to acute malnutrition (AM)

Number of children who develop AM (MAM or SAM) during follow-up divided by total at risk at discharge.

Time frame

Up to 12 months post-discharge

Cumulative incidence of relapse to MAM

Number of children who develop MAM during follow-up divided by total at risk at discharge.

Time frame

Up to 12 months post-discharge

Cumulative incidence of relapse to SAM

Number of children who develop SAM during follow-up divided by total at risk at discharge.

Time frame

Up to 12 months post-discharge

Other outcomes

Gut microbiome diversity as measured by Shannon and Simpson diversity indices

Time frame

OTP admission, OTP discharge, and 3, 6, 7, 9, and 12 months post-discharge

Gut microbiome composition as measured by taxonomic relative abundance and Bray-Curtis beta-diversity

Time frame

OTP admission, OTP discharge, and 3, 6, 7, 9, and 12 months post-discharge

Gut antibiotic resistance gene carriage as measured by abundance of total and macrolide-specific antibiotic resistance genes

Time frame

OTP admission, OTP discharge, and 3, 6, 7, 9, and 12 months post-discharge

Locations

Map coordinates are unavailable for these locations. Locations are shown below instead.

Action Against Hunger USA Status unavailable Gogrial West, Warrap

South Sudan

Sponsors and contacts

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Action Against Hunger USA

Lead sponsor

University of Washington

Collaborator

Harvard School of Public Health (HSPH)

Collaborator

Tufts University

Collaborator

Source ClinicalTrials.gov

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