A study to compare antibiotics used to treat children with severe acute malnutritio

Phase 3

Completed

• Conditions: Invasive bacterial infection, Severe acute malnutrition; Infections and Infestations

• Registration Number: ISRCTN18051843
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-09
• Study Completion: 2020-07-31
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1872

Inclusion Criteria

1. Age 2 months to 13 years inclusive
2. Severe malnutrition defined as:
2.1. Kwashiorkor at any age
2.2. For children between 6 to 59 months: MUAC <11.5cm or weight-for length Z score <-3
2.3. For children aged 2 to 5 months: MUAC <11cm or weight-for length Z score <-3
2.4. For children aged 5 to 13 years: BMI-for-age Z score <-3 or MUAC <11.5cm
3. Admitted to hospital and eligible for intravenous antibiotics according to WHO guidelines
4. Planning to remain within the hospital catchment area and willing to come for specified visits during the 90 day follow up period
5. Informed consent provided by the parents/guardian

Exclusion Criteria

1. Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or metronidazole
2. A specific and documented clinical indication for another class of antibiotic
3. Previously enrolled in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality is measured using source documents from medical records, verbal autopsy, or death or burial certificates in the community from enrolment to 90 days after enrolment.