First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition

• Status: Active, not recruiting
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya; Coast General Hospital, Mombasa, Kenya; KEMRI-Wellcome Trust Collaborative Research Program; KEMRI/Wellcome Trust Research Programme, Kilifi, Kenya.; Kenya Medical Research Institute; London School of Hygiene & Tropical Medicine, UK.; London School of Hygiene and Tropical Medicine; Mbagathi Hospital, Nairobi, Kenya; Mbale Regional Referral Hospital, Mbale, Uganda; Swansea Trials Unit; Swansea Trials Unit, Swansea University Medical School, Swansea, UK.; University College London, UK.; University College, London
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antitubercular; Ceftriaxone; Gentamicins; Metronidazole; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillins

Criteria

Inclusion:

• Age 2 months to 13 years inclusive

• Severe malnutrition defined as:

• kwashiorkor at any age or:

• for children between 2 to 5 months: MUAC <11cm or weight-for length Z score <-3

• for children between 6 to 59 months: MUAC <11.5cm or weight-for length Z score <-3

• for children between 5 to 13 years: MUAC <11.5cm or BMI-for-age Z score <-3

• Admitted to hospital and eligible for intravenous antibiotics according to WHO guidelines

• Planning to remain within the hospital catchment area and willing to come for specified visits during the 90 day follow up period

• Informed consent provided by the parents/guardian

Exclusion:

• Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or metronidazole

• A specific and documented clinical indication for another class of antibiotic

• Previously enrolled in this study