First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition

Summary

Children with severe malnutrition who are admitted sick to hospitals have a high mortality(death rate), usually because of infection. All children with severe malnutrition admitted to hospitals are treated with antibiotics(medication used to kill bacteria). However, the current antibiotics used in hospitals may not be the most effective. It is possible that the antibiotics that are currently used after initial antibiotics should be used first. No studies have been carried out to determine if the current antibiotics used for treating malnourished children who are sick and admitted in hospital are the most appropriate. The aim of this study is to find out if a changed antibiotic system for children with malnutrition is safe, reduces the risk of death and improves nutritional recovery.

Conditions

• Malnutrition Severe
• Antibiotic Resistance
• Antibiotic Toxicity

Interventions

DRUG

Ceftriaxone

Ceftriaxone a third-generation cephalosporin. Ceftriaxone is active against a broad spectrum of Gram positive and Gram negative bacteria.

DRUG

Benzyl penicillin

The currently recommended first-line antibiotics for the treatment of severe acute malnutrition are gentamicin plus ampicillin or penicillin.

DRUG

Metronidazole

The WHO guidelines recommend that Metronidazole may be given in addition to broad-spectrum antibiotics, "however, the efficacy of this treatment has not been established in clinical trials."

OTHER

Placebo

Suspension manufactured to match metronidazole

DRUG

Gentamicin

The currently recommended first-line antibiotics for the treatment of severe acute malnutrition are gentamicin plus ampicillin or penicillin.

Sponsors & Collaborators

• University College, London

  collaborator OTHER

• London School of Hygiene and Tropical Medicine

  collaborator OTHER

• Swansea Trials Unit

  collaborator UNKNOWN

• Kenya Medical Research Institute

  collaborator OTHER

• KEMRI-Wellcome Trust Collaborative Research Program

  collaborator OTHER

• University of Oxford

  lead OTHER

Principal Investigators

• James A Berkely, FRCPCH · KEMRI/Wellcome Trust Research Programme & University of Oxford

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

FACTORIAL

Eligibility

Min Age

2 Months

Max Age

13 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-09-04

Primary Completion

2020-01-31

Completion

2020-12-31

Countries

• Kenya
• Uganda

Study Locations