Malnutrition Clinical Trial
— FLACSAM-PKOfficial title:
Pharmacokinetics of Antimicrobials and Carriage of Antimicrobial Resistance Amongst Hospitalised Children With Severe Acute Malnutrition
Verified date | June 2017 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 81 |
Est. completion date | September 30, 2017 |
Est. primary completion date | September 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 59 Months |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Kenya | KEMRI WT Clinical Trials Facility | Kilifi |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | 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, University College, London |
Kenya,
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* Note: There are 22 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area under the curve (AUC) of ceftriaxone | To determine the pharmacokinetics of intravenous ceftriaxone given at currently recommended dose and frequency amongst severely malnourished, sick children. | 24 hours | |
Primary | Trough level of metronidazole | To determine the pharmacokinetics of oral metronidazole given at currently recommended dose and frequency amongst severely malnourished, sick children. | 8, 24, 48 and 72 hours | |
Secondary | Prevalence of faecal carriage of extended spectrum beta-lactamase (ESBL) | To determine the frequency of faecal carriage of ESBL at admission to hospital and at discharge amongst children admitted with and without severe malnutrition. | Through study completion, an average of 5 days |
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