Economic Evaluation support to a trial that assess strategies to address anti-microbial resistance in malnourished children (FLACSAM)

Investigators: Anna Vassall, Julie Jemutai (KEMRI-Wellcome Trust Research Programme)

Funding: Joint Global Health Trials Scheme – DFID, Wellcome Trust

Summary: An economic evaluatoin of first Line Antimicrobials in Children with Complicated Severe Acute Malnutrition. Children with complicated severe acute malnutrition (SAM) admitted to hospital in sub-Saharan Africa have a case fatality of 12% to more than 20%. Because children with SAM may not exhibit the usual signs of infection, WHO guidelines recommend routine antibiotics. However, this is based on “low quality evidence”. There is evidence from CGMR-C, Kilifi and from other centres in Africa that bacterial resistance to the currently recommended first-line antibiotics (gentamicin plus ampicillin or penicillin) may be a problem. Some hospitals in Africa are already increasing use of ceftriaxone as a first-line treatment. However, this is not based on any data that ceftriaxone actually improves outcomes. Of concern is that ceftriaxone use may also lead to increased antimicrobial resistance, including inducing extended spectrum beta-lactamase (ESBL) and other classes of resistance. This clinical trial will assess the efficacy of two interventions, ceftriaxone and metronidazole, on mortality and nutritional recovery in sick, severely malnourished children in a 2×2 factorial design. There will also be an analysis of antimicrobial resistance and an economic analysis.