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Not yet recruitingNCT07871955RAMPUpdated Oct 13, 2026

The Relapse to Acute Malnutrition Prevention (RAMP) Trial

An interventional study of Azithromycin and Placebo (Azithromycin) in Acute Malnutrition in Childhood and Acute Malnutrition, Severe, sponsored by Action Against Hunger USA. Not yet recruiting at 1 site in South Sudan. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Action Against Hunger USA · Not applicable, Interventional, and Prevention

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
3,750
Allocation
Randomized
Ages
6 Months to 59 Months
Sex
All
01

Study summary

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.

Read the detailed description

If there is a shortage of supply for one intervention or the another, we will enroll in the arms where we have supplies until all supplies are secured.

02

Conditions studied

  • Acute Malnutrition in Childhood
  • Acute Malnutrition, Severe
03

In context

Severe Acute Malnutrition

89 studies on the registry are indexed under Severe Acute Malnutrition; 14 are open to participants now.

This study's planned enrollment of 3,750 is above the median of 400 across 73 interventional studies indexed under Severe Acute Malnutrition.

Browse Severe Acute Malnutrition studies →

Lead sponsor

Action Against Hunger USA is the lead sponsor of 4 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 59 Months
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Initial phase criteria (upon admission to SAM treatment)

  • 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.
  • Provision of informed consent by a caregiver for the child's participation

Inclusion Criteria: Second phase criteria (upon discharge from SAM treatment)

  • Age 6-47 months
  • Determined to be recovered from SAM, defined as MUAC ≥ 12.5 cm, WHZ ≥ -2 SD, and no nutritional edema for two consecutive OTP visits
  • Verification that the family plans to continue residing in the catchment area of a study site with no plans to move for next 12 months
  • Verification of informed consent for the child's continued participation
  • Agreement to return to the study site monthly for the next 12 months
  • Agreement to be randomized to one of the four study arms and to provide their child with the randomized intervention(s)

Exclusion Criteria: Initial phase criteria (upon admission to SAM treatment)

  • 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

Exclusion Criteria: Second phase criteria (upon discharge from SAM treatment)

  • Age below 6 months or above 47 months
  • Known allergies or contraindications to macrolide antibiotics
  • Exited from OTP with a final discharge outcome as requiring hospitalization or defaulted
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
3,750 participants (estimated)

Study arms

  • Active comparator
    Control

    Standard of care + placebo

    Drug: Placebo (Azithromycin)

  • Experimental
    RAMP Experimental A

    Azithromycin only

    Drug: Azithromycin

  • Experimental
    RAMP Experimental B

    SQ-LNS only

    Drug: Placebo (Azithromycin) · Dietary Supplement: Small-quantity Lipid-based Nutrient Supplements

  • Experimental
    RAMP Experimental C

    Azithromycin + SQ-LNS

    Drug: Azithromycin · Dietary Supplement: Small-quantity Lipid-based Nutrient Supplements

Interventions

  • DrugAzithromycin

    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.

  • DrugPlacebo (Azithromycin)

    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.

  • Dietary supplementSmall-quantity Lipid-based Nutrient Supplements

    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.

06

What researchers measure

Primary outcomes

  1. 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

  1. 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.

  2. 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

  3. 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

  4. 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

  5. Cumulative mortality

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

    Time frame: Up to 12 months post-discharge

  6. Weight gain velocity

    Change in g/kg/day

    Time frame: Monthly for up to 12 months post-discharge

  7. Change in MUAC

    Change in cm

    Time frame: Monthly for up to 12 months post-discharge

  8. Change in length/height

    Change in cm

    Time frame: Monthly for up to 12 months post-discharge

  9. Change in weight-for-height z-score (WHZ)

    Change in WHZ calculated using the 2006 WHO Growth Standards

    Time frame: Monthly for up to 12 months post-discharge

  10. Change in height-for-age z-score (HAZ)

    Change in HAZ calculated using the 2006 WHO Growth Standards

    Time frame: Monthly for up to 12 months post-discharge

  11. Change in weight-for-age z-score (WAZ)

    Change in WAZ calculated using the 2006 WHO Growth Standards

    Time frame: Monthly for up to 12 months post-discharge

Other outcomes

  1. 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

  2. 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

  3. 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

07

Study locations

1 site
  • Action Against Hunger USA
    Gogrial West, Warrap, South Sudan
    • Stella Guwoly Henry · Contact · gstella@ssd-actionagainsthunger.org · +211-926-640-008
    • Heather Stobaugh · Principal investigator
    • Indi Trehan · Principal investigator
    • Khamisa Ayoub · Sub investigator
    • Bailey Clark · Sub investigator
    • Sarah King · Sub investigator
    • Ana Marshak · Sub investigator
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2028, 26 months later.

Of 35 non-industry interventional studies with no phase under Severe Acute Malnutrition, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 28. This study's planned 26 months is above that.

Counting every sponsor, half of 35 studies reached it within 14 months; a quarter within 10 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2026
First posted
Oct 13, 2026
StartEst.
Oct 2026
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2028
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07871955
Lead sponsor
Action Against Hunger USA
Collaborators
University of Washington, Harvard School of Public Health (HSPH), Tufts University
Responsible party
Heather Stobaugh (Associate Director of Research and Innovation, Action Against Hunger USA) — Principal investigator
First posted
Oct 13, 2026
Start date
Oct 2026 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Oct 13, 2026

Study contacts

Heather Stobaugh, PhD
Contact
researchteam@actionagainsthunger.org
+1(212) 967-7800

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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