[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659915":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":67,"studyPopulation":51,"armGroups":68,"interventions":90,"overallOfficials":51,"centralContacts":105,"locations":111,"responsibleParty":136,"collaborators":138,"id":145,"slug":146,"hasResults":147,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":147,"sex":153,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":51,"studyType":159,"phases":160,"briefSummary":162,"conditions":163,"keywords":51,"overallStatus":166,"whyStopped":51,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Action Against Hunger USA","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"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.","Up to 12 months post-discharge",[14,18,21,24,27,30,34,37,39,42,45],{"measure":15,"description":16,"timeFrame":17},"Sustained recovery at 6 months","Proportion of children who achieve sustained recovery at the end of the six-month intervention period.","6 months post-discharge.",{"measure":19,"description":20,"timeFrame":12},"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.",{"measure":22,"description":23,"timeFrame":12},"Cumulative incidence of relapse to MAM","Number of children who develop MAM during follow-up divided by total at risk at discharge.",{"measure":25,"description":26,"timeFrame":12},"Cumulative incidence of relapse to SAM","Number of children who develop SAM during follow-up divided by total at risk at discharge.",{"measure":28,"description":29,"timeFrame":12},"Cumulative mortality","Number of children who die during follow-up divided by total at risk at discharge.",{"measure":31,"description":32,"timeFrame":33},"Weight gain velocity","Change in g\u002Fkg\u002Fday","Monthly for up to 12 months post-discharge",{"measure":35,"description":36,"timeFrame":33},"Change in MUAC","Change in cm",{"measure":38,"description":36,"timeFrame":33},"Change in length\u002Fheight",{"measure":40,"description":41,"timeFrame":33},"Change in weight-for-height z-score (WHZ)","Change in WHZ calculated using the 2006 WHO Growth Standards",{"measure":43,"description":44,"timeFrame":33},"Change in height-for-age z-score (HAZ)","Change in HAZ calculated using the 2006 WHO Growth Standards",{"measure":46,"description":47,"timeFrame":33},"Change in weight-for-age z-score (WAZ)","Change in WAZ calculated using the 2006 WHO Growth Standards",[49,53,55],{"measure":50,"description":51,"timeFrame":52},"Gut microbiome diversity as measured by Shannon and Simpson diversity indices",null,"OTP admission, OTP discharge, and 3, 6, 7, 9, and 12 months post-discharge",{"measure":54,"description":51,"timeFrame":52},"Gut microbiome composition as measured by taxonomic relative abundance and Bray-Curtis beta-diversity",{"measure":56,"description":51,"timeFrame":52},"Gut antibiotic resistance gene carriage as measured by abundance of total and macrolide-specific antibiotic resistance genes",{"allocation":58,"interventionModel":59,"interventionModelDescription":51,"primaryPurpose":60,"observationalModel":51,"timePerspective":51,"maskingInfo":61},"RANDOMIZED","FACTORIAL","PREVENTION",{"masking":62,"maskingDescription":63,"whoMasked":64},"DOUBLE","The azithromycin will be fully blinded to all (participant, care provider, investigator, outcome assessor); however, there is no \"placebo\" version of SQ-LNS. Therefore, the SQ-LNS arms will not be blinded to participants and care providers. However, all data will be blinded to the outcomes assessors and investigators (data analysts).",[65,66],"INVESTIGATOR","OUTCOMES_ASSESSOR","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.",[69,75,81,86],{"label":70,"type":71,"description":72,"interventionNames":73},"Control","ACTIVE_COMPARATOR","Standard of care + placebo",[74],"Drug: Placebo (Azithromycin)",{"label":76,"type":77,"description":78,"interventionNames":79},"RAMP Experimental A","EXPERIMENTAL","Azithromycin only",[80],"Drug: Azithromycin",{"label":82,"type":77,"description":83,"interventionNames":84},"RAMP Experimental B","SQ-LNS only",[74,85],"Dietary Supplement: Small-quantity Lipid-based Nutrient Supplements",{"label":87,"type":77,"description":88,"interventionNames":89},"RAMP Experimental C","Azithromycin + SQ-LNS",[80,85],[91,96,100],{"type":92,"name":93,"description":94,"armGroupLabels":95,"otherNames":51},"DRUG","Azithromycin","A single oral dose of 20mg\u002Fkg 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\u002F5mL oral suspension reconstituted on-site and dosed using a calibrated dosing cup.",[76,87],{"type":92,"name":97,"description":98,"armGroupLabels":99,"otherNames":51},"Placebo (Azithromycin)","A single oral dose of matched placebo suspension equivalent to a 20mg\u002Fkg 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\u002F5mL matched oral suspension reconstituted on-site and dosed using a calibrated dosing cup.",[70,82],{"type":101,"name":102,"description":103,"armGroupLabels":104,"otherNames":51},"DIETARY_SUPPLEMENT","Small-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.",[82,87],[106],{"name":107,"role":108,"phone":109,"phoneExt":51,"email":110},"Heather Stobaugh, PhD","CONTACT","+1(212) 967-7800","researchteam@actionagainsthunger.org",[112],{"facility":5,"status":51,"city":113,"state":114,"zip":51,"country":115,"countryCode":116,"cosmosGeoPoint":51,"geoPoint":51,"contacts":117},"Gogrial West","Warrap","South Sudan","SS",[118,122,125,127,130,132,134],{"name":119,"role":108,"phone":120,"phoneExt":51,"email":121},"Stella Guwoly Henry","+211-926-640-008","gstella@ssd-actionagainsthunger.org",{"name":123,"role":124,"phone":51,"phoneExt":51,"email":51},"Heather Stobaugh","PRINCIPAL_INVESTIGATOR",{"name":126,"role":124,"phone":51,"phoneExt":51,"email":51},"Indi Trehan",{"name":128,"role":129,"phone":51,"phoneExt":51,"email":51},"Khamisa Ayoub","SUB_INVESTIGATOR",{"name":131,"role":129,"phone":51,"phoneExt":51,"email":51},"Bailey Clark",{"name":133,"role":129,"phone":51,"phoneExt":51,"email":51},"Sarah King",{"name":135,"role":129,"phone":51,"phoneExt":51,"email":51},"Ana Marshak",{"type":124,"investigatorFullName":123,"investigatorTitle":137,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Associate Director of Research and Innovation",[139,141,143],{"name":140,"class":6},"University of Washington",{"name":142,"class":6},"Harvard School of Public Health (HSPH)",{"name":144,"class":6},"Tufts University","100659915","the-relapse-to-acute-malnutrition-prevention-ramp-trial-100659915",false,"NCT07871955","The Relapse to Acute Malnutrition Prevention (RAMP) Trial","The RAMP Trial: Effectiveness of Azithromycin and Small-quantity Lipid-based Nutrient Supplements (SQ-LNS) on Sustained Nutritional Recovery Among Children Recovered From Uncomplicated Severe Acute Malnutrition in South Sudan","RAMP","Inclusion Criteria: Initial phase criteria (upon admission to SAM treatment)\n\n* Age 6-44 months\n* Diagnosed with uncomplicated SAM (MUAC \\\u003C 11.5 cm and\u002For WHZ \\\u003C -3 SD and\u002For bilateral pitting edema)\n* Being admitted to an outpatient therapeutic program (OTP) at one of the outpatient treatment sites where the study is conducted\n* Residing in the catchment area of a study OTP site with no plans to move elsewhere for the next 15 months.\n* Provision of informed consent by a caregiver for the child's participation\n\nInclusion Criteria: Second phase criteria (upon discharge from SAM treatment)\n\n* Age 6-47 months\n* Determined to be recovered from SAM, defined as MUAC ≥ 12.5 cm, WHZ ≥ -2 SD, and no nutritional edema for two consecutive OTP visits\n* 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\n* Verification of informed consent for the child's continued participation\n* Agreement to return to the study site monthly for the next 12 months\n* Agreement to be randomized to one of the four study arms and to provide their child with the randomized intervention(s)\n\nExclusion Criteria: Initial phase criteria (upon admission to SAM treatment)\n\n* Age below 6 months or above 44 months\n* Signs of severe illness requiring hospitalization\n* Hospitalized prior to OTP admission (including in a stabilization center)\n* Prior treatment for acute malnutrition within three months preceding study enrollment\n\nExclusion Criteria: Second phase criteria (upon discharge from SAM treatment)\n\n* Age below 6 months or above 47 months\n* Known allergies or contraindications to macrolide antibiotics\n* Exited from OTP with a final discharge outcome as requiring hospitalization or defaulted","ALL","6 Months","59 Months",{"count":157,"type":158},3750,"ESTIMATED","INTERVENTIONAL",[161],"NA","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.",[164,165],"Acute Malnutrition in Childhood","Acute Malnutrition, Severe","NOT_YET_RECRUITING","2026-10-07",{"date":169,"type":170},"2026-10-13","ACTUAL",{"date":172,"type":158},"2026-10",{"date":174,"type":158},"2028-12",{"name":5,"class":6},1]