Optimising Antibiotic Treatment for Sick Malnourished Children

PHASE2UnknownINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

April 1, 2016

Primary Completion Date

September 30, 2016

Study Completion Date

September 30, 2017

Conditions
Malnutrition
Interventions
DRUG

Ceftriaxone

Ceftriaxone is active against a broad spectrum of gram positive and gram negative bacteria, including intracellular bacteria (e.g. Salmonellae, Staphylococci). Its antibacterial effect is dependent on time above the minimum inhibitory concentration(MIC). Ceftriaxone is highly protein-bound and elimination depends on glomerular filtration rate. In severely ill adults, elimination is highly variable. Alteration in plasma proteins, volume of distribution and renal function in sick severely malnourished children could significantly alter pharmacokinetics (PK). Despite several published studies on the PK of ceftriaxone in children, none have included severe malnutrition.

DRUG

Metronidazole

Metronidazole is effective against Giardia, which is common amongst children with SAM; and against other anaerobic infections, including small bowel bacterial overgrowth and Clostridium difficile colitis. Small cohort studies suggest there may be benefits for nutritional recovery. However, metronidazole can cause nausea and anorexia, potentially impairing recovery from malnutrition and may also cause liver and neurological toxicity. Changes in body composition as well as metabolic and drug elimination mechanisms may alter the potential toxicity or effective dose.

Trial Locations (1)

80800

KEMRI WT Clinical Trials Facility, Kilifi

All Listed Sponsors
collaborator

KEMRI-Wellcome Trust Collaborative Research Program

OTHER

collaborator

Centre for Research in Therapeutic Sciences, Strathmore University, Nairobi Kenya

UNKNOWN

collaborator

University College, London

OTHER

collaborator

Centre for Microbiology Research, Kenya Medical Research Institute

UNKNOWN

collaborator

Centre for Clinical Research, Kenya Medical Research Institute

UNKNOWN

lead

University of Oxford

OTHER