Controlling intestinal bacteria in severely ill children with malnutrition.

Phase 3

• Conditions: Digestive System; Sepsis; Nutritional, Metabolic, Endocrine; Paediatrics

• Registration Number: PACTR202102678743565
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

•Age =2 to <59 months
•Admitted to hospital with an acute, non-traumatic illness and within 72 hours of admission at the time of enrolment
•Severe malnutrition (weight-for-height <-3 z scores of the median WHO growth standards and/or mid upper arm circumference <115mm (<110mm age below 6 months), or symmetrical oedema of at least the feet related to malnutrition (not related to a primary cardiac or renal disorder)
•Presence of two or more features of severity as specified in the protocol and trial SOP. If a child meets two criteria, they may be enrolled before further criteria are assessed (e.g. a child may be eligible on clinical signs before the complete blood count results are known).
•Accompanied by care provider who provides written informed consent
•Primary caregiver plans to stay in the study area during the duration of the study.

Exclusion Criteria

•Requires immediate cardiac/respiratory resuscitation (may be re-evaluated for study eligibility within 72h of admission)
•Presence of terminal illness (other than severe acute malnutrition) likely to result in death within 6 months in the opinion of the recruitment team
•Known congenital heart disease
•Admission for traumatic or surgical indication
•Known liver disorder or exocrine pancreatic disorder – e.g. biliary atresia, history of gallstones, cystic fibrosis or clinical jaundice
•Known stomach or duodenal ulcer
•Residence is outside the catchment area of study hospital
•Primary caregiver declines to provide informed consent
•Known intolerance or allergy to any study medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death

Secondary Outcome Measures

Name	Time	Method
Serious Adverse Events of any cause to day 60<br><br><br>;Safety: grade 3 or 4 toxicity events;Number of days with diarrhoea and stool consistency during admission;Number of days with clinical features of sepsis (fever, impaired circulation) during admission;Usage of second and third-line antibiotics during index admission and readmission as recorded by the study team;Number of days from enrolment to discharge during the index admission ;Change in MUAC, weight-for-length, length-for-age from enrolment to days 21 and 60