Optimizing the use of antibiotics in uncomplicated severe acute malnutrition management at the community level

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.

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15929485

Enrollment

362

Registered

2024-01-12

Start date

2021-11-15

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe acute malnutrition Nutritional, Metabolic, Endocrine

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Determinants of risk factors of SAM measured using questionnaire at baseline	—

Countries

India

Contacts

Public ContactYashwant Kumar Rao

ykraoneo@yahoo.co.in+91 9919080807

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026