Whether there is a need to give medicine to control bacteria to all children with severe low weight for their height? Can one dose of azithromycin (medicine to control bacteria) replace one week of amoxicillin (medicine to control bacteria)?

Is empirical antibiotics necessary for Community-based management of Severe Acute Malnutrition (CSAM) in children. Can single-dose Azithromycin replace one-week Amoxycillin for CSAM: Randomized-Control trial - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082358

Enrollment

750

Registered

2025-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: E43- Unspecified severe protein-caloriemalnutrition

Interventions

Intervention1: Amoxicillin: Amoxicillin, twice daily (BD) for five days for group A participants Intervention2: Azithromycin: Azithromycin, single dose for group B study participants Control Intervent

Eligibility

Inclusion criteria

Inclusion criteria: 7-59 months children enrolled in SSFP/ CMAM programme WHZ -3D or MUAC 115mm, passed appetite test using balamrutham plus (RUTF), both gender, available for full 8-week study, no oedema, no antibiotic use in past one month, no clinical complication requiring antibiotic treatment, no clinical complication requiring inpatient care, primary resident of the catchment area. The children who participated in phase 1 will also be eligible to be part of phase II RCT provided no significant growth in blood, urine, or stool culture.

Exclusion criteria

Exclusion criteria: Children identified as complicated case of SAM Children with antibiotic use in last one month.

Design outcomes

Primary

Measure	Time frame
1. Proportion with clinical infections (based on clinical evaluation), subclinical infections (elevated hs-CRP, procalcitonin, WBC, and ESR), pattern of antimicrobial sensitivity and resistance among 6-59 months children with uncomplicated SAM. 2.Efficacy of broad-spectrum antibiotic (amoxicillin - twice daily for seven days) compared to single dose azithromycin against the group without antibiotics among uncomplicated SAM from 7-59 months.Timepoint: Objective 1 - Baseline Objective 2 - at the end of 4 months and 6 months of the trial	—

Measure

Time frame

1. Proportion with clinical infections (based on clinical evaluation), subclinical infections (elevated hs-CRP, procalcitonin, WBC, and ESR), pattern of antimicrobial sensitivity and resistance among 6-59 months children with uncomplicated SAM. 2.Efficacy of broad-spectrum antibiotic (amoxicillin - twice daily for seven days) compared to single dose azithromycin against the group without antibiotics among uncomplicated SAM from 7-59 months.Timepoint: Objective 1 - Baseline Objective 2 - at the end of 4 months and 6 months of the trial

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Secondary

Measure	Time frame
2. Qualitative data on antibiotic usage preference among the mothers/ caregivers of children with uncomplicated SAM & health seeking preference, challenges & enablers in management of these children.Timepoint: The data collection will be based on cross sectional study design & the qualitative data based on Focus Group Discussions & Indepth Interviews will be done in the intial 6 months period. This outcome is not part of the RCT.	—

Measure

Time frame

2. Qualitative data on antibiotic usage preference among the mothers/ caregivers of children with uncomplicated SAM & health seeking preference, challenges & enablers in management of these children.Timepoint: The data collection will be based on cross sectional study design & the qualitative data based on Focus Group Discussions & Indepth Interviews will be done in the intial 6 months period. This outcome is not part of the RCT.

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Countries

India

Contacts

Public ContactDr Gomathi R

All India Institute of Medical Sciences, Bibinagar

gmthramaswamy@gmail.com8883422073

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 4, 2026