Severe Acute MalnutritionPhase 3Co-SAMNCT05994742
An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM
A Phase 3 study testing Rifampicin, Azithromycin and Isoniazid in people with Severe Acute Malnutrition and HIV, run by Queen Mary University of London at 9 sites in 3 countries.
Trial summary
Malnutrition underlies 45% of child deaths, and has far-reaching educational, economic and health consequences. Severe acute malnutrition (SAM) affects 17 million children globally and is the most life-threatening form of malnutrition. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Severe Acute Malnutrition, HIV, Comorbidities and Coexisting Conditions
- What is being tested?
- Rifampicin, Azithromycin and Isoniazid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 674 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 15 Jul 2024to 30 Jul 2026
- Phase
- Phase 3
- 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 6-59 months, of either sex
- Hospitalised with complicated severe acute malnutrition, as per WHO definition
- Started transition to RUTF
- Caregiver willing and able to attend the study clinic for all visits
- Caregiver able and willing to give informed consent
Who cannot join
- Any acute or chronic condition which mean that receipt of one or more study interventions, or participation in the trial, would not be advisable.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Kenya4 sites
Homa Bay
Homa Bay
Mbagathi Hospital
Mbagathi
Migori Referral Hospital
Migori
Coast General
Mombasa
Zimbabwe3 sites
Chitungwiza Central Hospital
Harare
Parirenyatwa Hospital
Harare
Sally Mugabe Hospital
Harare
About this study
Official title: Co-SAM: An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated Severe Acute Malnutrition
Malnutrition underlies 45% of child deaths, and has far-reaching educational, economic and health consequences. Severe acute malnutrition (SAM) affects 17 million children globally and is the most life-threatening form of malnutrition. Community-based management of acute malnutrition using ready-to-use therapeutic food (RUTF) has transformed outcomes for children with uncomplicated SAM, but those presenting with poor appetite or medical complications (categorised as having 'complicated' SAM) require hospitalisation. Data show that pneumonia, diarrhoea and malaria are leading causes of death in children with complicated SAM after discharge from hospital. High risk of infectious deaths suggests that sustained antimicrobial interventions may reduce mortality following discharge from hospital. Furthermore, children with complicated SAM respond less well to nutritional rehabilitation, and oftentimes are discharged to a home environment characterised by poverty and multiple caregiver vulnerabilities including depression, low decision making autonomy, lack of social support, gender-restricted family relations, and competing demands on scarce resources. Caregivers have to navigate diverse challenges that impede engagement with clinical care after discharge from hospital. The objective is to address the biological and social determinants of multimorbidity in children with complicated SAM by comparing an antimicrobial intervention with standard of care.
Read the detailed description
This is a 3-arm randomized, unblinded clinical trial comparing:
Arm 1: Standard-of-care (control) Arm 2: Antimicrobial package Arm 3: Psychosocial package.
The trial will test the superiority of each intervention arm over the standard of care arm (control). Children in the control arm (and all intervention arms) will receive RUTF for at least 2 weeks and all standard care. The trial is adaptive, meaning i) that each intervention arm will be added as it becomes available, and ii) an interim analysis will enable us to drop arms which are unpromising based on pre-specified criteria. There will be no blinding or placebo, because the very different components in each trial arm make it very challenging to blind. Children with complicated SAM will be screened and enrolled from hospital sites shortly before discharge, and interventions will be started before leaving hospital, and continued for 12 weeks through outpatient visits. Children will be followed at 2, 4, 6, 8, 12 and 24 weeks post-discharge in dedicated study clinics (with additional visits at 1, 3 and 5 weeks for caregiver-child pairs receiving the psychosocial intervention).
The primary outcome is death or hospitalization or failed nutritional recovery by 24 weeks.
The study is not testing new drugs but rather testing a different package of medications as compared to current standard care, which are designed to prevent a range of infections during convalescence.
The Psychosocial intervention will involve three components:
- The Friendship Bench, which was developed in Zimbabwe as a low-cost psychological intervention utilising problem-solving therapy (delivered by trained lay workers) and peer-to-peer support to address depression and other common mental disorders. There is a strong evidence-base for its use in urban LMIC settings. Peer support groups meet every 1-2 weeks and focus on communal problem solving, and establishing income-generation activities (such as making bags). ii) Care for Child Development is a UNICEF package that helps families build stronger relationships and solve problems in caring for the child at home, through play and communication activities to stimulate children, through a series of age-appropriate interactive modules delivered by a lay worker using 'flash' cards. It has been used in other African contexts and has good acceptability. iii) Educational and behavior-change messages around better nutrition; play for children with SAM; stigma, HIV and gender-based violence; financial planning; causes of SAM; and health-seeking behaviours.
Blood and stool will be collected at baseline, 12 and 24 weeks from all children to explore recovery of underlying pathological processes. At week 2, liver function tests will be undertaken in local laboratories.
- Conditions
- Severe Acute Malnutrition, HIV, Comorbidities and Coexisting Conditions, Child Malnutrition
- Being tested
- Rifampicin, Azithromycin, Isoniazid, Pyridoxine Hydrochloride, Standard Care
- Medical subject headings
- Severe Acute Malnutrition, Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifampicinDrug
Rifampicin is commonly used in the first-line management of paediatric tuberculosis, and is approved by the FDA (ID: 2862628) and the EMA (EMA/31710/2020).
AzithromycinDrug
Azithromycin is a macrolide antibiotic, and is approved for use in children by the FDA (ID: 3263750) and EMA (EMA/2872/2021).
IsoniazidDrug
Isoniazid is an antibiotic commonly used in the firstline treatment of tuberculosis, and as tuberculosis prophylaxis.
Pyridoxine HydrochlorideDrug
Pyridoxine is a form of vitamin B6 used to prevent peripheral neuropathy among children receiving isoniazid.
Standard CareOther
All children will receive care according to WHO guidelines, which includes standard RUTF and any other medications required.
The Friendship BenchBehavioural
The Friendship Bench was developed in Zimbabwe as a low-cost psychological intervention utilising problem-solving therapy (delivered by trained lay workers) and peer-to-peer support to address depression and other common mental disorders. There is a strong evidence-base for its use in urban LMIC settings. Peer support groups meet every 1-2 weeks and focus on communal problem solving, and establishing income-generation activities (such as making bags).
Care for Child DevelopmentBehavioural
Care for Child Development is a UNICEF package that helps families build stronger relationships and solve problems in caring for their child at home, through play and communication activities to stimulate children, through a series of age-appropriate interactive modules delivered by a lay worker using 'flash' cards. It has been used in other African contexts and has good acceptability.
Other Behavioural SupportBehavioural
Educational and behaviour-change messages around better nutrition; play for children with SAM; stigma, HIV and gender-based violence; financial planning; causes of SAM; and health-seeking behaviours. These have been developed with caregivers affected by SAM in a previous study, through a series of co-design workshops, ensuring they are contextually relevant.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Standard-of-care (control) | Active comparator | Children in the control arm will receive Ready to Use Therapeutic Food (RUTF) for at least 2 weeks, plus all standard care. Children with HIV will receive long-term Cotrimoxazole prophylaxis and antiretroviral therapy, as per current guidelines. Receives: Other: Standard Care |
| Arm 2: Antimicrobial package | Experimental | Children will receive a bundle of azithromycin (3 days every month), isoniazid (daily), rifampicin (daily) and pyridoxine (daily) for 12 weeks. Receives: Drug: Rifampicin; Drug: Azithromycin; Drug: Isoniazid; Drug: Pyridoxine Hydrochloride; Other: Standard Care |
| Arm 3: Psychosocial Support (PSS) Package | Experimental | During the Psychosocial Support intervention, caregiver-child pairs receive weekly intervention visits at weeks 1, 3, and 5. These visits are designed to deliver weekly problem-solving therapy and behavior-change modules for a total duration of 6 weeks. The content and focus of these psychosocial sessions aim to support the psychosocial well-being of the participants. Additionally, there are standard intervention visits for all arms at weeks 2, 4, 6, 8, and 12 post-randomization, which include other aspects of the intervention such as the resupply of Ready-to-Use Therapeutic Food (RUTF). Receives: Other: Standard Care; Behavioral: The Friendship Bench; Behavioral: Care for Child Development; Behavioral: Other Behavioural Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death or first hospitalisation or failed nutritional recovery within 24 weeks post-randomisation
- All-cause mortality. b) Overnight admission to a health facility for any reason. This includes cases where there was a clinical plan to hospitalise the child, which was refused by the caregiver. c) Failed nutritional recovery is defined as either: i) Persistent WHZ<-2 or MUAC<12.5cm or bilateral pedal oedema at week 12; or ii) WHZ<-2 or MUAC<12.5cm or bilateral pedal oedema at any time between baseline and week 24 post-randomisation in a child who had previously recovered.
Measured: 24 weeks post-randomisation
Secondary outcomes (5)
Change in weight-for-height Z-score
Change in weight-for-height Z-score between baseline and 24 weeks post-randomisation according to age- and-sex appropriate WHO reference standards.
Measured: 24 weeks post-randomisation
Change in mid-upper arm circumference
Change in size of mid-upper arm in centimetres between baseline and 24 weeks.
Measured: 24 weeks post-randomisation
Change in weight-for-age Z-score
Change in weight-for-age Z-score between baseline and 24 weeks post-randomisation according to age- and sex-appropriate WHO reference standards.
Measured: 24 weeks post-randomisation
Change in height-for-age Z-score
Change in height-for-age Z-score between baseline and 24 weeks post-randomisation according to age- and sex-appropriate WHO reference standards.
Measured: 24 weeks post-randomisation
Number of participants with suspected or confirmed tuberculosis,pneumonia, diarrhoea or malaria
Physician-diagnosed suspected or confirmed infection, as defined by WHO guidelines, between baseline and 24 weeks post-randomisation.
Measured: 24 weeks post-randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2023
- Study start15 Jul 2024
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Adaptive, multi-arm randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 674 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, KEMRI-Wellcome Trust Collaborative Research Program, University of Washington, Zvitambo Institute for Maternal & Child Health, Tropical Gastroenterology & Nutrition Group (TROPGAN), University of Cambridge, Kenya Medical Research Institute, National Institute for Health Research, United Kingdom, University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05994742
- Sponsor's protocol ID
- 150522
- Acronym
- Co-SAM
- Status last verified
- Aug 2026
- First submitted
- 14 Jul 2023
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared at the end of the trial on ClinEpiDB.
Publications
Bwakura-Dangarembizi M, Amadi B, Singa BO, Muyemayema S, Ngosa D, Mwalekwa L, Ngao N, Kazhila L, Mutasa B, Mpofu E, Mudawarima L, Gonzales GB, Mudzingwa S, Mutenda M, Keter LK, Mutasa K, Njunge JM, Jones H, Phiri TN, Mudibo E, Chulu N, Majo FD, Chasekwa B, Tembo A, Nyabinda C, Oduol C, Sauramba V, Tavengwa NV, Langhaug L, Cordani I, Smuk M, Jaki T, Ntozini R, Walson J, Tickell KD, Berkley J, Kelly P, Prendergast AJ; Co-SAM Trial Team. An adaptive multiarm randomised trial of biomedical and psychosocial interventions to improve convalescence following severe acute malnutrition in sub-Saharan Africa: Co-SAM trial protocol. BMJ Open. 2025 May 24;15(5):e093758. doi: 10.1136/bmjopen-2024-093758.
PubMed 40413053
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-SAM: An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated Severe Acute Malnutrition
- ClinicalTrials.gov ID
- NCT05994742
- Acronym / sponsor ID
- Co-SAM / 150522
- Conditions
- Severe Acute Malnutrition, HIV, Comorbidities and Coexisting Conditions, Child Malnutrition
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 674 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University of Oxford, KEMRI-Wellcome Trust Collaborative Research Program, University of Washington, Zvitambo Institute for Maternal & Child Health, Tropical Gastroenterology & Nutrition Group (TROPGAN), University of Cambridge, Kenya Medical Research Institute, National Institute for Health Research, United Kingdom, University Ghent
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 16 Aug 2023 (actual)
- 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.
Malnutrition underlies 45% of child deaths, and has far-reaching educational, economic and health consequences. Severe acute malnutrition (SAM) affects 17 million children globally and is the most life-threatening form of malnutrition. Community-based management of acute malnutrition using ready-to-use therapeutic food (RUTF) has transformed outcomes for children with uncomplicated SAM, but those presenting with poor appetite or medical complications (categorised as having 'complicated' SAM) require hospitalisation. Data show that pneumonia, diarrhoea and malaria are leading causes of death in children with complicated SAM after discharge from hospital. High risk of infectious deaths suggests that sustained antimicrobial interventions may reduce mortality following discharge from hospital. Furthermore, children with complicated SAM respond less well to nutritional rehabilitation, and oftentimes are discharged to a home environment characterised by poverty and multiple caregiver vulnerabilities including depression, low decision making autonomy, lack of social support, gender-restricted family relations, and competing demands on scarce resources. Caregivers have to navigate diverse challenges that impede engagement with clinical care after discharge from hospital. The objective is to address the biological and social determinants of multimorbidity in children with complicated SAM by comparing an antimicrobial intervention with standard of care.
Detailed description
This is a 3-arm randomized, unblinded clinical trial comparing:
Arm 1: Standard-of-care (control) Arm 2: Antimicrobial package Arm 3: Psychosocial package.
The trial will test the superiority of each intervention arm over the standard of care arm (control). Children in the control arm (and all intervention arms) will receive RUTF for at least 2 weeks and all standard care. The trial is adaptive, meaning i) that each intervention arm will be added as it becomes available, and ii) an interim analysis will enable us to drop arms which are unpromising based on pre-specified criteria. There will be no blinding or placebo, because the very different components in each trial arm make it very challenging to blind. Children with complicated SAM will be screened and enrolled from hospital sites shortly before discharge, and interventions will be started before leaving hospital, and continued for 12 weeks through outpatient visits. Children will be followed at 2, 4, 6, 8, 12 and 24 weeks post-discharge in dedicated study clinics (with additional visits at 1, 3 and 5 weeks for caregiver-child pairs receiving the psychosocial intervention).
The primary outcome is death or hospitalization or failed nutritional recovery by 24 weeks.
The study is not testing new drugs but rather testing a different package of medications as compared to current standard care, which are designed to prevent a range of infections during convalescence.
The Psychosocial intervention will involve three components:
- The Friendship Bench, which was developed in Zimbabwe as a low-cost psychological intervention utilising problem-solving therapy (delivered by trained lay workers) and peer-to-peer support to address depression and other common mental disorders. There is a strong evidence-base for its use in urban LMIC settings. Peer support groups meet every 1-2 weeks and focus on communal problem solving, and establishing income-generation activities (such as making bags). ii) Care for Child Development is a UNICEF package that helps families build stronger relationships and solve problems in caring for the child at home, through play and communication activities to stimulate children, through a series of age-appropriate interactive modules delivered by a lay worker using 'flash' cards. It has been used in other African contexts and has good acceptability. iii) Educational and behavior-change messages around better nutrition; play for children with SAM; stigma, HIV and gender-based violence; financial planning; causes of SAM; and health-seeking behaviours.
Blood and stool will be collected at baseline, 12 and 24 weeks from all children to explore recovery of underlying pathological processes. At week 2, liver function tests will be undertaken in local laboratories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Adaptive, multi-arm randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Standard-of-care (control) | Active comparator | Other: Standard CareChildren in the control arm will receive Ready to Use Therapeutic Food (RUTF) for at least 2 weeks, plus all standard care. Children with HIV will receive long-term Cotrimoxazole prophylaxis and antiretroviral therapy, as per current guidelines. |
| Arm 2: Antimicrobial package | Experimental | Drug: Rifampicin, Drug: Azithromycin, Drug: Isoniazid, Drug: Pyridoxine Hydrochloride, Other: Standard CareChildren will receive a bundle of azithromycin (3 days every month), isoniazid (daily), rifampicin (daily) and pyridoxine (daily) for 12 weeks. |
| Arm 3: Psychosocial Support (PSS) Package | Experimental | Other: Standard Care, Behavioral: The Friendship Bench, Behavioral: Care for Child Development, Behavioral: Other Behavioural SupportDuring the Psychosocial Support intervention, caregiver-child pairs receive weekly intervention visits at weeks 1, 3, and 5. These visits are designed to deliver weekly problem-solving therapy and behavior-change modules for a total duration of 6 weeks. The content and focus of these psychosocial sessions aim to support the psychosocial well-being of the participants. Additionally, there are standard intervention visits for all arms at weeks 2, 4, 6, 8, and 12 post-randomization, which include other aspects of the intervention such as the resupply of Ready-to-Use Therapeutic Food (RUTF). |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6-59 months, of either sex
- Hospitalised with complicated severe acute malnutrition, as per WHO definition
- Started transition to RUTF
- Caregiver willing and able to attend the study clinic for all visits
- Caregiver able and willing to give informed consent
Key exclusion criteria (1 listed)
- Any acute or chronic condition which mean that receipt of one or more study interventions, or participation in the trial, would not be advisable.
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 |
|---|---|---|
| RifampicinRifampicin is commonly used in the first-line management of paediatric tuberculosis, and is approved by the FDA (ID: 2862628) and the EMA (EMA/31710/2020). | Drug | Arm 2: Antimicrobial package |
| AzithromycinAzithromycin is a macrolide antibiotic, and is approved for use in children by the FDA (ID: 3263750) and EMA (EMA/2872/2021). | Drug | Arm 2: Antimicrobial package |
| IsoniazidIsoniazid is an antibiotic commonly used in the firstline treatment of tuberculosis, and as tuberculosis prophylaxis. | Drug | Arm 2: Antimicrobial package |
| Pyridoxine HydrochloridePyridoxine is a form of vitamin B6 used to prevent peripheral neuropathy among children receiving isoniazid. | Drug | Arm 2: Antimicrobial package |
| Standard CareAll children will receive care according to WHO guidelines, which includes standard RUTF and any other medications required. | Other | Arm 1: Standard-of-care (control), Arm 2: Antimicrobial package, Arm 3: Psychosocial Support (PSS) Package |
| The Friendship BenchThe Friendship Bench was developed in Zimbabwe as a low-cost psychological intervention utilising problem-solving therapy (delivered by trained lay workers) and peer-to-peer support to address depression and other common mental disorders. There is a strong evidence-base for its use in urban LMIC settings. Peer support groups meet every 1-2 weeks and focus on communal problem solving, and establishing income-generation activities (such as making bags). | Behavioural | Arm 3: Psychosocial Support (PSS) Package |
| Care for Child DevelopmentCare for Child Development is a UNICEF package that helps families build stronger relationships and solve problems in caring for their child at home, through play and communication activities to stimulate children, through a series of age-appropriate interactive modules delivered by a lay worker using 'flash' cards. It has been used in other African contexts and has good acceptability. | Behavioural | Arm 3: Psychosocial Support (PSS) Package |
| Other Behavioural SupportEducational and behaviour-change messages around better nutrition; play for children with SAM; stigma, HIV and gender-based violence; financial planning; causes of SAM; and health-seeking behaviours. These have been developed with caregivers affected by SAM in a previous study, through a series of co-design workshops, ensuring they are contextually relevant. | Behavioural | Arm 3: Psychosocial Support (PSS) Package |
Primary outcome
Death or first hospitalisation or failed nutritional recovery within 24 weeks post-randomisation
Time frame: 24 weeks post-randomisation
a) All-cause mortality. b) Overnight admission to a health facility for any reason. This includes cases where there was a clinical plan to hospitalise the child, which was refused by the caregiver. c) Failed nutritional recovery is defined as either: i) Persistent WHZ<-2 or MUAC<12.5cm or bilateral pedal oedema at week 12; or ii) WHZ<-2 or MUAC<12.5cm or bilateral pedal oedema at any time between baseline and week 24 post-randomisation in a child who had previously recovered.
5 secondary outcomes
Change in weight-for-height Z-score
Time frame: 24 weeks post-randomisation
Change in mid-upper arm circumference
Time frame: 24 weeks post-randomisation
Change in weight-for-age Z-score
Time frame: 24 weeks post-randomisation
Change in height-for-age Z-score
Time frame: 24 weeks post-randomisation
Number of participants with suspected or confirmed tuberculosis,pneumonia, diarrhoea or malaria
Time frame: 24 weeks post-randomisation
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 25 Aug 2026.
- Derived from this study: PubMed 40413053Bwakura-Dangarembizi M, Amadi B, Singa BO, Muyemayema S, Ngosa D, Mwalekwa L, Ngao N, Kazhila L, Mutasa B, Mpofu E, Mudawarima L, Gonzales GB, Mudzingwa S, Mutenda M, Keter LK, Mutasa K, Njunge JM, Jones H, Phiri TN, Mudibo E, Chulu N, Majo FD, Chasekwa B, Tembo A, Nyabinda C, Oduol C, Sauramba V, Tavengwa NV, Langhaug L, Cordani I, Smuk M, Jaki T, Ntozini R, Walson J, Tickell KD, Berkley J, Kelly P, Prendergast AJ; Co-SAM Trial Team. An adaptive multiarm randomised trial of biomedical and psychosocial interventions to improve convalescence following severe acute malnutrition in sub-Saharan Africa: Co-SAM trial protocol. BMJ Open. 2025 May 24;15(5):e093758. doi: 10.1136/bmjopen-2024-093758.
- Individual participant dataSharing planned: Yes. Data will be shared at the end of the trial on ClinEpiDB.
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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.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifampicin, Azithromycin and Isoniazid in people with Severe Acute Malnutrition and HIV, run by Queen Mary University of London at 9 sites in 3 countries.
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 5 inclusion and 1 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 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Kenya, Zimbabwe, Zambia. 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?
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?
Death or first hospitalisation or failed nutritional recovery within 24 weeks post-randomisation (time frame: 24 weeks post-randomisation). 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 NCT05994742, which also lists 1 linked publication.
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 25 Aug 2026.