Optimising Antibiotic Treatment for Sick Malnourished Children

• Status: Unknown status
• Trial end date: 2017-09-30
• Target enrollment: 0
• Participant gender: All

Summary

Children with severe malnutrition who are admitted sick to hospitals have a high mortality, usually because of infection. All children with severe malnutrition admitted to hospitals are treated with antibiotics. However, policymakers are not sure that the current antibiotics are the most effective. It is possible that the antibiotics that are currently used as second-line should be used first. Finding this out will need a large trial comparing different antibiotics. To prepare for such a trial the investigators first want to make sure that the doses given are correct for malnourished children. The investigators also want to check whether malnourished children more commonly carry resistant bacteria in their feces than well-nourished children. The study is important because the types of antibiotics and the doses needed to fight infection may be different in malnourished children because of the changes in their body due to malnutrition and the types of bacteria present.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oxford
• Collaborators: Centre for Clinical Research, Kenya Medical Research Institute; Centre for Microbiology Research, Kenya Medical Research Institute; Centre for Research in Therapeutic Sciences, Strathmore University, Nairobi Kenya; KEMRI Wellcome Trust Research Program, Kenya; KEMRI-Wellcome Trust Collaborative Research Program; University College, London
• Treatments: Anti-Bacterial Agents; Anti-Infective Agents; Ceftriaxone; Metronidazole

Criteria

Inclusion Criteria:

• Severe acute malnutrition(SAM) defined as:

• Children aged 6 to 59 months with kwashiorkor; or Mid-Upper Arm Circumference (MUAC) <11.5cm; or weight-for height Z score <-3;

• Children aged 2 to 5 months with kwashiorkor; or MUAC <11cm; or weight-for height Z score <-3; and weight >2.5 kilograms(kg);

• Eligible to receive intravenous antibiotics according to current national guidelines

For faecal carriage: children aged 2 to 59 months with and without SAM (as defined above) who are admitted to hospital with a syndrome requiring antimicrobial treatment under current national guidelines.

Exclusion Criteria:

• Admitted as a transfer from another hospital.

• Known ceftriaxone or metronidazole administration within the previous 7 days (pharmacokinetics(PK) study only).

• Known allergy or contraindication to ceftriaxone or metronidazole (including penicillin allergy) (PK study only).

• A specific clinical indication for another class of antibiotic (PK study only).

• Concurrent participation in a clinical trial (PK study only).

• Attending clinician's judgement that the child is so severely ill that adequate communication about the study with the parent or legal guardian is not possible.

• Refusal of consent