81
Participants
Start Date
April 1, 2016
Primary Completion Date
September 30, 2016
Study Completion Date
September 30, 2017
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.
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.
KEMRI WT Clinical Trials Facility, Kilifi
Collaborators (1)
KEMRI-Wellcome Trust Collaborative Research Program
OTHER
Centre for Research in Therapeutic Sciences, Strathmore University, Nairobi Kenya
UNKNOWN
University College, London
OTHER
Centre for Microbiology Research, Kenya Medical Research Institute
UNKNOWN
Centre for Clinical Research, Kenya Medical Research Institute
UNKNOWN
University of Oxford
OTHER