Severe Acute MalnutritionNCT01613547
The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications
A study testing Amoxicillin in people with Severe Acute Malnutrition, run by Epicentre at 1 site in Niger.
Trial summary
This study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition
- What is being tested?
- Amoxicillin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,412 participants
- Where
- 1 siteNiger
- Study dates
- Oct 2012to May 2014
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 6 to 59 months
- MUAC < 11.5 cm or WHZ < -3
- Absence of bipedal edema
- Absence of current illness requiring inpatient care
- Eligible for new admission for outpatient nutritional therapy for SAM at 3 CRENAS in Madarounfa operated by FORSANI
- Absence of current clinical illness requiring prescription of specific antibiotic therapy and decision by the study physician to use a specific antimicrobial drug on admission
- Written consent of parent or caregiver
- Residence within Niger
Who cannot join
- Age < 6 months or > 59 months
- MUAC ≥ 11.5 cm and WHZ ≥ -3
- Presence of bipedal edema
- Presence of current illness requiring inpatient care
- Decision by the study physician to use a specific different antimicrobial drug on admission
- Presence of any congenital abnormality or underlying chronic disease that may affect growth or risk of infection
Show all 9Show fewer
- Treatment with any antibiotic within 7 days
- Admission to any nutritional program for the treatment of SAM within 3 months
- Known contraindication / hypersensitivity to amoxicillin
Trial locations and contacts
1 site in 1 country.
Niger1 site
Centres de Récupération et d'Education Nutritionnelle Ambulatoires de Dan Issa, Madarounfa, and Gabi
Maradi
About this study
Official title: The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications: Maradi, Niger
This study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. The investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.
- Conditions
- Severe Acute Malnutrition
- Being tested
- Amoxicillin, Placebo
- Medical subject headings
- Severe Acute Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
80 mg/kg/day for 7 days
PlaceboDrug
7 days
| Study group | Role | What they receive |
|---|---|---|
| Routine antibiotic prescription | Active comparator | Routine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days) Receives: Drug: Amoxicillin |
| No routine antibiotic prescription | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children discharged from nutritional program as recovered
Measured: Until discharge from the nutritional program, an expected average of 5 weeks
Secondary outcomes (1)
Hospitalization or death
Measured: 3 months following enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Severe Acute MalnutritionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2,412 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands, FORSANI, District Sanitaire de Madarounfa, Région de Maradi, Ministere de la Sante Publique du Niger, Bichat Hospital
- Responsible party
- Principal investigator, Sheila Isanaka, Epicentre
- Investigators
- Sheila Isanaka, ScD, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613547
- Sponsor's protocol ID
- EPI/NIGER/821242
- Status last verified
- May 2014
- First submitted
- 26 May 2012
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rattigan SM, Grantz KH, Hanson K, Langendorf C, Berthe F, Grais R, Isanaka S. Prescribing practices in the treatment of wasting: secondary analysis from a randomised trial. BMJ Nutr Prev Health. 2024 Feb 26;7(1):103-111. doi: 10.1136/bmjnph-2023-000785. eCollection 2024.
PubMed 38966095Schwartz DJ, Langdon A, Sun X, Langendorf C, Berthe F, Grais RF, Trehan I, Isanaka S, Dantas G. Effect of amoxicillin on the gut microbiome of children with severe acute malnutrition in Madarounfa, Niger: a retrospective metagenomic analysis of a placebo-controlled trial. Lancet Microbe. 2023 Nov;4(11):e931-e942. doi: 10.1016/S2666-5247(23)00213-6. Epub 2023 Oct 19.
PubMed 37866373Bliznashka L, Grantz KH, Botton J, Berthe F, Garba S, Hanson KE, Grais RF, Isanaka S. Burden and risk factors for relapse following successful treatment of uncomplicated severe acute malnutrition in young children: Secondary analysis from a randomised trial in Niger. Matern Child Nutr. 2022 Oct;18(4):e13400. doi: 10.1111/mcn.13400. Epub 2022 Jul 21.
PubMed 35866201Madzorera I, Duggan C, Berthe F, Grais RF, Isanaka S. The role of dietary diversity in the response to treatment of uncomplicated severe acute malnutrition among children in Niger: a prospective study. BMC Nutr. 2018 Sep 20;4:35. doi: 10.1186/s40795-018-0242-y. eCollection 2018.
PubMed 32153896Maataoui N, Langendorf C, Berthe F, Bayjanov JR, van Schaik W, Isanaka S, Grais RF, Clermont O, Andremont A, Armand-Lefevre L, Woerther PL. Increased risk of acquisition and transmission of ESBL-producing Enterobacteriaceae in malnourished children exposed to amoxicillin. J Antimicrob Chemother. 2020 Mar 1;75(3):709-717. doi: 10.1093/jac/dkz487.
PubMed 31821452Oldenburg CE, Guerin PJ, Berthe F, Grais RF, Isanaka S. Malaria and Nutritional Status Among Children With Severe Acute Malnutrition in Niger: A Prospective Cohort Study. Clin Infect Dis. 2018 Sep 14;67(7):1027-1034. doi: 10.1093/cid/ciy207.
PubMed 29522089Isanaka S, Langendorf C, Berthe F, Gnegne S, Li N, Ousmane N, Harouna S, Hassane H, Schaefer M, Adehossi E, Grais RF. Routine Amoxicillin for Uncomplicated Severe Acute Malnutrition in Children. N Engl J Med. 2016 Feb 4;374(5):444-53. doi: 10.1056/NEJMoa1507024.
PubMed 26840134
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Routine Antibiotic Use in the Outpatient Treatment of Severely Malnourished Children Without Complications: Maradi, Niger
- ClinicalTrials.gov ID
- NCT01613547
- Acronym / sponsor ID
- EPI/NIGER/821242
- Conditions
- Severe Acute Malnutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,412 participants (estimated)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Medecins Sans Frontieres, Netherlands, FORSANI, District Sanitaire de Madarounfa, Région de Maradi, Ministere de la Sante Publique du Niger, Bichat Hospital
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Jun 2012 (estimated)
- 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.
This study will be conducted as a randomized, double-blind, placebo-controlled trial to compare routine antibiotic prescription vs. no routine antibiotic prescription in the management of uncomplicated cases of severe acute malnutrition treated in the community in terms of nutritional recovery. The investigators hypothesize that there will be no significant difference in terms of the risk of nutritional recovery among children uncomplicated cases of severe acute malnutrition treated in the community that receive routine antibiotic prescription and those who receive no routine antibiotic prescription.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine antibiotic prescription | Active comparator | Drug: AmoxicillinRoutine antibiotic prescription with amoxicillin (80 mg/kg/day for 7 days) |
| No routine antibiotic prescription | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age from 6 to 59 months
- MUAC < 11.5 cm or WHZ < -3
- Absence of bipedal edema
- Absence of current illness requiring inpatient care
- Eligible for new admission for outpatient nutritional therapy for SAM at 3 CRENAS in Madarounfa operated by FORSANI
Key exclusion criteria (9 listed)
- Age < 6 months or > 59 months
- MUAC ≥ 11.5 cm and WHZ ≥ -3
- Presence of bipedal edema
- Presence of current illness requiring inpatient care
- Decision by the study physician to use a specific different antimicrobial drug on admission
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 |
|---|---|---|
| Amoxicillin80 mg/kg/day for 7 days | Drug | Routine antibiotic prescription |
| Placebo7 days | Drug | No routine antibiotic prescription |
Primary outcome
Proportion of children discharged from nutritional program as recovered
Time frame: Until discharge from the nutritional program, an expected average of 5 weeks
1 secondary outcome
Hospitalization or death
Time frame: 3 months following enrollment
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 21 May 2014.
- Derived from this study: PubMed 38966095Rattigan SM, Grantz KH, Hanson K, Langendorf C, Berthe F, Grais R, Isanaka S. Prescribing practices in the treatment of wasting: secondary analysis from a randomised trial. BMJ Nutr Prev Health. 2024 Feb 26;7(1):103-111. doi: 10.1136/bmjnph-2023-000785. eCollection 2024.
- Derived from this study: PubMed 37866373Schwartz DJ, Langdon A, Sun X, Langendorf C, Berthe F, Grais RF, Trehan I, Isanaka S, Dantas G. Effect of amoxicillin on the gut microbiome of children with severe acute malnutrition in Madarounfa, Niger: a retrospective metagenomic analysis of a placebo-controlled trial. Lancet Microbe. 2023 Nov;4(11):e931-e942. doi: 10.1016/S2666-5247(23)00213-6. Epub 2023 Oct 19.
- Derived from this study: PubMed 35866201Bliznashka L, Grantz KH, Botton J, Berthe F, Garba S, Hanson KE, Grais RF, Isanaka S. Burden and risk factors for relapse following successful treatment of uncomplicated severe acute malnutrition in young children: Secondary analysis from a randomised trial in Niger. Matern Child Nutr. 2022 Oct;18(4):e13400. doi: 10.1111/mcn.13400. Epub 2022 Jul 21.
- Derived from this study: PubMed 32153896Madzorera I, Duggan C, Berthe F, Grais RF, Isanaka S. The role of dietary diversity in the response to treatment of uncomplicated severe acute malnutrition among children in Niger: a prospective study. BMC Nutr. 2018 Sep 20;4:35. doi: 10.1186/s40795-018-0242-y. eCollection 2018.
- Derived from this study: PubMed 31821452Maataoui N, Langendorf C, Berthe F, Bayjanov JR, van Schaik W, Isanaka S, Grais RF, Clermont O, Andremont A, Armand-Lefevre L, Woerther PL. Increased risk of acquisition and transmission of ESBL-producing Enterobacteriaceae in malnourished children exposed to amoxicillin. J Antimicrob Chemother. 2020 Mar 1;75(3):709-717. doi: 10.1093/jac/dkz487.
- Derived from this study: PubMed 29522089Oldenburg CE, Guerin PJ, Berthe F, Grais RF, Isanaka S. Malaria and Nutritional Status Among Children With Severe Acute Malnutrition in Niger: A Prospective Cohort Study. Clin Infect Dis. 2018 Sep 14;67(7):1027-1034. doi: 10.1093/cid/ciy207.
- Derived from this study: PubMed 26840134Isanaka S, Langendorf C, Berthe F, Gnegne S, Li N, Ousmane N, Harouna S, Hassane H, Schaefer M, Adehossi E, Grais RF. Routine Amoxicillin for Uncomplicated Severe Acute Malnutrition in Children. N Engl J Med. 2016 Feb 4;374(5):444-53. doi: 10.1056/NEJMoa1507024.
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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.
Sheila Isanaka, ScD principal investigator
Epicentre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amoxicillin in people with Severe Acute Malnutrition, run by Epicentre at 1 site in Niger.
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 8 inclusion and 9 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 21 May 2014. 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 Niger. 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. Some participants in this study may receive a placebo. 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 discharged from nutritional program as recovered (time frame: Until discharge from the nutritional program, an expected average of 5 weeks). 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 NCT01613547, which also lists 7 linked publications.
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 21 May 2014; AzTrials last refreshed its copy on 7 Nov 2026.