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Comparation of Ampicillin-Gentamicin and Ceftriaxone- Gentamicin in the Treatment of Diarrhea with Dehydration in Hospitalized Children of Severe Acute Malnutrition (SAM) Between 2 Months- 5 Years by comparing duration of hospital stay between both the groups.

Comparative Efficacy Between Ampicillin-Gentamicin and Ceftriaxone- Gentamicin in the Treatment of Diarrhea with Dehydration in Hospitalized Children Between 2 Months- 5 Years with Severe Acute Malnutrition (SAM):A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097217
Enrollment
80
Registered
2025-11-11
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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: Ceftriaxone-Gentamicin: Inj.Ceftriaxone 100 mg/kg/day in 2 divided doses and Inj. Gentamicin 7.5mg/kg once a day for 7-10 days and the standard treatment. Control Intervention1: Ampicil

Sponsors

Dr.Srikanta Basu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children aged 2 months to 5 years with SAM and complications admitted in our hospital. 2. Children having diarrhea with dehydration without signs of shock 3.Case definition- Diagnostic criteria of SAM in children from 6-59 months of age: Weight for height less than -3SD or Mid arm circumference(MUAC) of less than 115mm or Bilateral pitting edema of both feet Diagnostic criteria of SAM in infants of less than 6months of age and more than 45 cm in length: Weight-for-height less than -3SD or bilateral pitting edema of both feet( nutritional origin) or both

Exclusion criteria

Exclusion criteria: 1.Patient having diarrhea with dehydration with signs of shock. 2.Children were excluded from the study if they had been had received oral or parenteral antibiotics for more than 48 hrs in the previous seven days. 3. Children with known chronic liver, kidney, cardiac disorders, HIV,TB, IEM etc 4. Known allergy or contraindication to Ampicillin, Gentamicin, Ceftriaxone.

Design outcomes

Primary

MeasureTime frame
Duration of hospital stay in days as per discharge criteria defined by: 1.Frequency of stool less than 5 per day 2.Accepting 80% of daily feeds 3.Minimum average weight gain in 3 days more than 5gm/kg/day 4.Resolution of other complications: hypoglycaemia, hypothermia, dyselectrolytemias. Timepoint: 4 weeks

Secondary

MeasureTime frame
Proportion of children achieving average weight gain in 3 days more than 5gm per kg per day: Defined as the mean weight gain per kilogram body weight recorded over three consecutive days during hospitalization.Timepoint: 3 days;Proportion of children with requirement for escalation for antibiotic therapy or change during the course of treatment as per unit protocol.Timepoint: ;Proportion of children having identifiable and culture positive diarhogenic bacteria in stool and blood before the initiation of antibiotics and before discharge in both the groupsTimepoint: ;Proportion of children developing adverse effects of drugs in both the group is defined as any new clinical symptom or lab abnormality temporally associated with the administered antibiotic(s), requiring: 1.Medical intervention 2.Dose modification 3.Drug discontinuation or substitution Timepoint:

Countries

India

Contacts

Public ContactAbhishek Anand

Lady Hardinge Medical College

srikantabasu@gmail.com9818291595

Outcome results

None listed

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