Optimizing the use of antibiotics in uncomplicated severe acute malnutrition management at the community level
| ISRCTN | ISRCTN15929485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15929485 |
| Secondary identifying numbers | 5/9/1338/2020-Nut |
- Submission date
- 27/12/2023
- Registration date
- 12/01/2024
- Last edited
- 12/01/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Children with straightforward severe acute malnutrition (SAM) shouldn't need to stay in the hospital; instead, they can be treated as outpatients and given a course of oral antibiotics like amoxicillin. It's important to note that diarrhea is a common side effect of antibiotic treatment, occurring in about 5-30% of patients.
Considering the widespread use of antibiotics, there are growing concerns about their impact on human health, especially the rise of drug-resistant bacteria. Therefore, it's crucial to optimize the use of antibiotics.
The aim of this study is to assess the clinical outcomes of managing uncomplicated severe acute malnutrition (SAM) at the community level with antibiotics compared to without antibiotics.
Who can participate?
Children aged 6 to 59 months with SAM
What does the study involve?
Participants will be randomly allocated to two groups. Group I will consist of uncomplicated severe acute malnutrition (SAM) children who will receive antibiotics for a week as part of the intervention. Group II will serve as the placebo group, comprising uncomplicated SAM children who will not receive antibiotics but will be given a placebo instead. Both Group I and Group II will undergo a thorough assessment, including a detailed clinical history and physical examination. Additionally, their nutritional status will be assessed through anthropometric measurements.
What are the possible benefits and risks of participating?
This study supports the WHO policy of antibiotic stewardship for rational antibiotic use by reducing the unnecessary use of antibiotics. There are no expected risks.
Where is the study run from?
Indian Council of Medical Research (India)
When is the study starting and how long is it expected to run for?
September 2021 to September 2024
Who is funding the study?
Indian Council of Medical Research (India)
Who is the main contact?
Dr Yashwant Kumar Rao, ykraoneo@yahoo.co.in
Contact information
Public, Scientific, Principal Investigator
P4, GSVM Medical College, Kanpur Nagar
Kanpur Nagar
208002
India
| Phone | +91 9919080807 |
|---|---|
| ykraoneo@yahoo.co.in |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Childcare/pre-school, Community, Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A randomised controlled trial to study the clinical outcome in the management of uncomplicated severe acute malnutrition children (6 months to 59 months) at the community level with antibiotics against without antibiotics. |
| Study objectives | Keeping in view the WHO Antimicrobial Stewardship Programmes (ASPs), we need to reassess the use of antibiotics in the management of uncomplicated severe acute malnutrition (SAM) at the community level. Even WHO and GoI have recommended the use of amoxicillin in uncomplicated SAM at the community level and also for community-acquired pneumonia amoxicillin is recommended. Since amoxicillin is the first-line drug for uncomplicated SAM, community-acquired pneumonia and other respiratory tract infections, its irrational use will increase morbidity and mortality if its resistance occurs. There is a very low proportion of infections in uncomplicated SAM, so there will be added cost and complexity with possible excessive toxicity after the use of amoxicillin. Therefore, we conducted this study to compare the clinical outcome in children with uncomplicated SAM managed with and without antibiotics. |
| Ethics approval(s) |
Approved 04/09/2021, Ethics Committee (For Biomedical Health & Research) (Room No. 125, lst FIoor, GSVM Medica! College, Kanpur, 208002, India; +91 9919080807; ykraoneo@yahoo.co.in), ref: EC/70/ Apr. / 2020 |
| Health condition(s) or problem(s) studied | Severe acute malnutrition |
| Intervention | A balanced block randomisation technique was used with a block size of 4 using tables taken from the website https://www.sealedenvelope.com. Group I will be the interventional group of uncomplicated SAM children receiving antibiotics for 1 week (amoxycillin syrup 40-45 mg/kg/day). Group II will be the placebo group of uncomplicated SAM children receiving no antibiotics but only placebo. Both group I and group II will be evaluated with a detailed clinical history physical examination. Their nutritional status will be determined by anthropometric measurement. The medical officer in charge of the local Primary Health Centre (PHC) and Accredited Social Health Activists (ASHA)/Anganwadi Workers (AWW)/Auxiliary Nurse Midwives (ANMs) will be informed about the details of each SAM child identified during the house-to-house visit for further management and help in follow-ups. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Dose response, Pharmacoeconomic |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Oral amoxicillin syrup |
| Primary outcome measure | 1. Clinical outcomes of management of uncomplicated severe acute malnutrition (SAM) at the community level measured using: 1.1. Weight for height z score, weight for age z score, and height for age z score at baseline, 15 days, 30 days, 45 days, 60 days 1.2. Biochemical investigations at baseline and 60 days |
| Secondary outcome measures | Determinants of risk factors of SAM measured using questionnaire at baseline |
| Overall study start date | 04/09/2021 |
| Completion date | 03/09/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 59 Months |
| Sex | Both |
| Target number of participants | 362 |
| Key inclusion criteria | Children aged 6 to 59 months with: 1. Weight for height below – 3 standard deviation (SD or Z scores) 2. Malnutrition with bilateral pedal edema or visible severe wasting 3. Mid upper arm circumference (MUAC) <115 mm |
| Key exclusion criteria | 1. Any congenital malformation 2. Chronic diseases except HIV and TB 3. Any previous antibiotic use within 14 days 4. SAM with complications |
| Date of first enrolment | 15/11/2021 |
| Date of final enrolment | 28/02/2024 |
Locations
Countries of recruitment
- India
Study participating centre
Uttar Pradesh
Kanpur Nagar
208002
India
Sponsor information
Government
V. Ramalingaswami Bhawan, PO Box No. 4911. Ansari Nagar
New Delhi
110029
India
| Phone | +91-11-26588895 |
|---|---|
| icmrhqds@sansad.nic.in | |
| Website | http://www.icmr.nic.in/ |
"ROR" |
https://ror.org/0492wrx28 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Indian Council of Medical Research, Government of India, Indian Council of Medical Research (ICMR), New Delhi, ICMROrganisation, भारतीय चिकित्सा अनुसंधान परिषद, Indian Council of Medical Research, New Delhi, ICMR, ICMRDELHI, आई.सी.एम.आर
- Location
- India
Results and Publications
| Intention to publish date | 01/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request, Published as a supplement to the results publication |
| Publication and dissemination plan | Published in Indian Journal of Pediatrics Future Plan: WHO Bulletin |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request: Dr Yashwant Kumar Rao (ykraoneo@yahoo.co.in). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/06/2023 | 28/12/2023 | Yes | No |
Editorial Notes
12/01/2024: Internal review.
08/01/2024: Study's existence confirmed by the Ethics Committee (For Biomedical Health & Research).
