Invasive bacterial infection, Severe acute malnutrition Infections and Infestations Invasive bacterial infection, Severe acute malnutrition
Conditions
Interventions
This study is testing two interventions. Participants are randomised to receive either one of two intravenous antimicrobial treatment arms and then are randomised again to one of two oral antimicrobia
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 2 months to 13 years inclusive 2. Severe malnutrition defined as: 2.1. Kwashiorkor at any age 2.2. For children between 6 to 59 months: MUAC <11.5cm or weight-for length Z score <-3 2.3. For children aged 2 to 5 months: MUAC <11cm or weight-for length Z score <-3 2.4. For children aged 5 to 13 years: BMI-for-age Z score <-3 or MUAC <11.5cm 3. Admitted to hospital and eligible for intravenous antibiotics according to WHO guidelines 4. Planning to remain within the hospital catchment area and willing to come for specified visits during the 90 day follow up period 5. Informed consent provided by the parents/guardian
Exclusion criteria
Exclusion criteria: 1. Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or metronidazole 2. A specific and documented clinical indication for another class of antibiotic 3. Previously enrolled in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality is measured using source documents from medical records, verbal autopsy, or death or burial certificates in the community from enrolment to 90 days after enrolment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Grade 4 toxicity events are measured according to the Division of AIDS Tables for Grading the Severity of Adverse Events using medical records from enrolment to end of the study 2. Serious adverse events are measured using inpatient and outpatient medical records from enrolment to 90 days after enrolment 3. Mortality within the first 48 hours after enrolment, by day 7 and until discharge from the index hospitalisation, is measured using inpatient records from enrolment to discharge from hospital 4. Mortality occurring after discharge from the index hospital admission is measured using source documents from inpatient medical records, verbal autopsy, or death or burial certificates in the community from discharge to 90 days after enrolment 5. Causes of death, as determined by an endpoint review committee from enrolment to 90 days after enrolment 6. Re-admission to hospital defined as at least one overnight stay in a hospital or health facility are measured using inpatient records from discharge from the index admission to 90 days after enrolment 7. Causes of re-admission, as determined by the admitting study clinician from discharge from the index admission to 90 days after enrolment 8. Total duration of hospitalisation is measured in days using inpatient records at the start and end of each admission to hospital from enrolment to 90 days after enrolment 9. Total duration of administration of antibiotics in hospital is measured using inpatient records at the start and end of each admission to hospital from enrolment to 90 days after enrolment 10. Change in nutritional status is measured using mid-upper arm circumference, weight-for-length, weight-for-age and length-for-age at enrolment, 14, 45 and 90 days after enrolment 11. Aetiology of invasive infections are measured using microbial culture and sensitivity testing of blood, cerebrospinal fluid, urine or other sterile site samples taken for clinical investigation from enrolment to 90 days after enrolment 12. Fae | — |
Countries
Kenya, Uganda
Contacts
Public ContactIsiah Njagi
Outcome results
None listed