Uncomplicated Severe Acute MalnutritionPhase 3SAMNCT03568643
Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)
A Phase 3 study testing Azithromycin and Amoxicillin in people with Uncomplicated Severe Acute Malnutrition, run by University of California, San Francisco at 1 site in Burkina Faso.
Trial summary
This pilot study is a randomized controlled trial designed to test the effect of the administration of adjunctive azithromycin in conjunction with standard outpatient treatment for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Uncomplicated Severe Acute Malnutrition
- What is being tested?
- Azithromycin and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 3 Jun 2020to 25 Dec 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6-59 months
- WHZ <-3 SD or MUAC <115 mm
- No nutritional edema
- Able and willing to participate in full 8-week study
- Has not been admitted to a nutritional program for the treatment of SAM in the 3 preceeding months
- No antibiotic use in past 7 days
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- No clinical complications requiring inpatient treatment (except for routine admission for children <6 months)
- No congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, etc)
- No allergy to macrolides/azalides
- Sufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
- Appropriate consent from at least one parent or guardian
Who cannot join
- Age <6 months or >59 months
- WHZ ≥-3 SD or MUAC ≥115 mm
- Nutritional edema
- Not able or willing to participate in full 8-week study
- Admission to a nutritional program for the treatment of SAM in the 3 preceeding months
- Antibiotic use in past 7 days
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- Clinical complications requiring inpatient treatment
- Congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease, cleft lip/palate, etc)
- Allergy to macrolides/azalides
- Insufficient appetite according to a feeding test with ready-to-use therapeutic food (RUTF)
- Parent or guardian refuses to provide consent
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Centre de Recherche en santé de nouna
Nouna, Boucle du Mouhoun
About this study
Official title: Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition:
This pilot study is a randomized controlled trial designed to test the effect of the administration of adjunctive azithromycin in conjunction with standard outpatient treatment for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Children presenting to nutritional programs in Burkina Faso who meet eligibility criteria will be randomized to a single dose of oral azithromycin or a 7-day course of amoxicillin (standard of care) upon admission into the program. All enrolled children will receive ready-to-use therapeutic foods (RUTF). Enrolled children will be followed at each weekly clinic follow-up visit up to 8 weeks following admission. Data on anthropometric indicators, vital status, and adverse events will be collected during follow-up. Nutritional recovery over the 8-week study period will be compared by arm.
- Conditions
- Uncomplicated Severe Acute Malnutrition
- Being tested
- Azithromycin, Amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Also called Zithromax
Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
AmoxicillinDrug
Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Experimental | children in this arm will receive one dose of azithromycin Receives: Drug: Azithromycin |
| Amoxicillin | Active comparator | Children in this arm will receive a 7 day course of amoxicillin (standard of care) Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain
Weight will be measured at all follow-up time points and weight gain will be calculated at 8 weeks
Measured: 8 weeks
Secondary outcomes (9)
Nutritional Recovery - Primary Definition
Nutritional recovery is defined as, depending on admission criteria: weight-for-height/length is equal to or more than -2 Z-score and the child have had no oedema for at least 2 weeks, or the mid-upper-arm circumference is equal to or more than 125 mm and the child have had no oedema for at least 2 weeks.
Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:
Stunted is length/height-for-age below the -2 z-score line. Severely stunted is below the -3 z-score line
Measured: 8 weeks
Nutritional Recovery - Secondary Definition
Summarize the cumulative proportion recovered by arm. Children are considered recovered if they had mean upper arm circumference > 12.5 or weight-for-height/length > -2 for 2 consecutive measurements. Additionally, it includes children who had had mean upper arm circumference >12.5 or weight-for-height/length > -2 on their final measurement, regardless of whether they met these criteria on the previous visit.
Measured: 8 weeks
Malaria
Rapid diagnostic tests for malaria will be conducted at baseline and week 8 to determine malaria infection status.
Measured: 8 weeks
Mortality
Vital status will be assessed at all follow-up time points and mortality will be defined as death during the study period.
Measured: 8 weeks
Length/Height-for-age Z-score (LAZ/HAZ)
Height or length will be measured at all follow-up time points and height-for-age z-scores will be calculated.
A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean.
Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:
Stunted is length/height-for-age below the -2 z-score line. Severely stunted is below the -3 z-score line
Measured: 8 weeks
Mid-Upper Arm Circumference (MUAC)
Mid-upper arm circumference will be measured at all follow-up time points
Measured: 8 weeks
Weight-for-Age Z-scores (WAZ)
Weight will be measured at all follow-up time points and weight-for-age z-scores will be calculated.
A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean.
Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:
Underweight is weight-for-age below the -2 z-score line. Severely underweight is below the -3 z-score line.
Measured: 8 weeks
Weight-for-Height Z-score (WHZ)
Weight and height, assessed at all follow-up time points, will be used to calculate weight-for-height z-scores.
A z-score of 0 represents the population mean. The z-score will be positive if the data value lies above the mean, and negative if the data value lies below the mean.
Anthropometric outcomes were defined according to the 2006 World Health Organization's Child Growth Standards:
Overweight is weight-for-length/height above the 2 z-score line. Severely overweight; weight-for-length/height above the 3 z-score line
Measured: 8 weeks
Intestinal Microbiome
baseline and 8 week intestinal microbiome will be compared between the 2 arms alpha diversity using inverse Simpson's index and Shannon's index, expressed in effective number.
The Shannon Diversity Index is a quantitative measure that reflects how many different bacterial species there are in a sample. The greater the index, the more diverse the gut microbiota. An index of 0 indicates a community that only has one species. A negative change indicates a decrease in diversity and a positive change indicates an increase in diversity.
The Simpson's Diversity Index is a measure of diversity which takes into account the number of species present, as well as the relative abundance of each species. As species richness and evenness increase, so diversity increases. The value ranges between 0 and 1, where 1 represents infinite diversity and 0, no diversity.
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start3 Jun 2020
- Primary completion25 Dec 2020
- Study completion25 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Uncomplicated Severe Acute MalnutritionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Catherine E Oldenburg, ScD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568643
- Sponsor's protocol ID
- 18-25274
- Other IDs
- 1R21HD100932-01A1
- Acronym
- SAM
- Status last verified
- Aug 2022
- First submitted
- 14 Jun 2018
- Last updated
- 1 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Oldenburg CE, Hinterwirth A, Dah C, Millogo O, Coulibaly B, Ouedraogo M, Sie A, Chen C, Zhong L, Ruder K, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Doan T. Gut Microbiome among Children with Uncomplicated Severe Acute Malnutrition in a Randomized Controlled Trial of Azithromycin versus Amoxicillin. Am J Trop Med Hyg. 2022 Dec 12;108(1):206-211. doi: 10.4269/ajtmh.22-0381. Print 2023 Jan 11.
PubMed 36509053Oldenburg CE, Hinterwirth A, Ourohire M, Dah C, Ouedraogo M, Sie A, Boudo V, Chen C, Ruder K, Zhong L, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Doan T. Gut Resistome after Antibiotics among Children with Uncomplicated Severe Acute Malnutrition: A Randomized Controlled Trial. Am J Trop Med Hyg. 2022 Jun 13;107(1):59-64. doi: 10.4269/ajtmh.22-0007. Print 2022 Jul 13.
PubMed 35895362Sie A, Dah C, Ourohire M, Ouedraogo M, Boudo V, Arzika AM, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Oldenburg CE. Azithromycin versus Amoxicillin and Malarial Parasitemia among Children with Uncomplicated Severe Acute Malnutrition: A Randomized Controlled Trial. Am J Trop Med Hyg. 2021 Sep 27;106(1):351-355. doi: 10.4269/ajtmh.21-0595.
PubMed 34583344O'Brien KS, Sie A, Dah C, Ourohire M, Arzika AM, Boudo V, Lebas E, Godwin WW, Arnold BF, Oldenburg CE. Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Apr 20;7(1):97. doi: 10.1186/s40814-021-00836-w.
PubMed 33879263
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Azithromycin as Adjunctive Therapy for Uncomplicated Severe Acute Malnutrition:
- ClinicalTrials.gov ID
- NCT03568643
- Acronym / sponsor ID
- SAM / 18-25274
- Conditions
- Uncomplicated Severe Acute Malnutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Centre de Recherche en Sante de Nouna, Burkina Faso, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 3 Jun 2020 (actual)
- Primary completion
- 25 Dec 2020 (actual)
- Study completion
- 25 Dec 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 1 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is a randomized controlled trial designed to test the effect of the administration of adjunctive azithromycin in conjunction with standard outpatient treatment for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Children presenting to nutritional programs in Burkina Faso who meet eligibility criteria will be randomized to a single dose of oral azithromycin or a 7-day course of amoxicillin (standard of care) upon admission into the program. All enrolled children will receive ready-to-use therapeutic foods (RUTF). Enrolled children will be followed at each weekly clinic follow-up visit up to 8 weeks following admission. Data on anthropometric indicators, vital status, and adverse events will be collected during follow-up. Nutritional recovery over the 8-week study period will be compared by arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Experimental | Drug: Azithromycinchildren in this arm will receive one dose of azithromycin |
| Amoxicillin | Active comparator | Drug: AmoxicillinChildren in this arm will receive a 7 day course of amoxicillin (standard of care) |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Age 6-59 months
- WHZ <-3 SD or MUAC <115 mm
- No nutritional edema
- Able and willing to participate in full 8-week study
- Has not been admitted to a nutritional program for the treatment of SAM in the 3 preceeding months
Key exclusion criteria (11 listed)
- Age <6 months or >59 months
- WHZ ≥-3 SD or MUAC ≥115 mm
- Nutritional edema
- Not able or willing to participate in full 8-week study
- Admission to a nutritional program for the treatment of SAM in the 3 preceeding months
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 |
|---|---|---|
| AzithromycinAlso: ZithromaxChildren enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF. | Drug | Azithromycin |
| AmoxicillinChildren enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF. | Drug | Amoxicillin |
Primary outcome
Weight Gain
Time frame: 8 weeks
Weight will be measured at all follow-up time points and weight gain will be calculated at 8 weeks
9 secondary outcomes
Nutritional Recovery - Primary Definition
Time frame: 8 weeks
Nutritional Recovery - Secondary Definition
Time frame: 8 weeks
Malaria
Time frame: 8 weeks
Mortality
Time frame: 8 weeks
Length/Height-for-age Z-score (LAZ/HAZ)
Time frame: 8 weeks
Mid-Upper Arm Circumference (MUAC)
Time frame: 8 weeks
Weight-for-Age Z-scores (WAZ)
Time frame: 8 weeks
Weight-for-Height Z-score (WHZ)
Time frame: 8 weeks
Intestinal Microbiome
Time frame: Baseline, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36509053Oldenburg CE, Hinterwirth A, Dah C, Millogo O, Coulibaly B, Ouedraogo M, Sie A, Chen C, Zhong L, Ruder K, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Doan T. Gut Microbiome among Children with Uncomplicated Severe Acute Malnutrition in a Randomized Controlled Trial of Azithromycin versus Amoxicillin. Am J Trop Med Hyg. 2022 Dec 12;108(1):206-211. doi: 10.4269/ajtmh.22-0381. Print 2023 Jan 11.
- Derived from this study: PubMed 35895362Oldenburg CE, Hinterwirth A, Ourohire M, Dah C, Ouedraogo M, Sie A, Boudo V, Chen C, Ruder K, Zhong L, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Doan T. Gut Resistome after Antibiotics among Children with Uncomplicated Severe Acute Malnutrition: A Randomized Controlled Trial. Am J Trop Med Hyg. 2022 Jun 13;107(1):59-64. doi: 10.4269/ajtmh.22-0007. Print 2022 Jul 13.
- Derived from this study: PubMed 34583344Sie A, Dah C, Ourohire M, Ouedraogo M, Boudo V, Arzika AM, Lebas E, Nyatigo F, Arnold BF, O'Brien KS, Oldenburg CE. Azithromycin versus Amoxicillin and Malarial Parasitemia among Children with Uncomplicated Severe Acute Malnutrition: A Randomized Controlled Trial. Am J Trop Med Hyg. 2021 Sep 27;106(1):351-355. doi: 10.4269/ajtmh.21-0595.
- Derived from this study: PubMed 33879263O'Brien KS, Sie A, Dah C, Ourohire M, Arzika AM, Boudo V, Lebas E, Godwin WW, Arnold BF, Oldenburg CE. Azithromycin for uncomplicated severe acute malnutrition: study protocol for a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Apr 20;7(1):97. doi: 10.1186/s40814-021-00836-w.
- Individual participant dataSharing planned: No
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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.
Catherine E Oldenburg, ScD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Azithromycin and Amoxicillin in people with Uncomplicated Severe Acute Malnutrition, run by University of California, San Francisco at 1 site in Burkina Faso.
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 11 inclusion and 11 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 1 Sep 2022. 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 Burkina Faso. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Weight Gain (time frame: 8 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 NCT03568643, which also lists 4 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 1 Sep 2022.