First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03174236
• Date of registration: 15/05/2017
• Prospective Registration: Yes
• Primary sponsor: University of Oxford
• Public title: First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition FLACSAM
• Scientific title: First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition
• Date of first enrolment: September 4, 2017
• Target sample size: 2000
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03174236
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Kenya, Uganda

Contacts

• Name: James A Berkely, FRCPCH
• Affiliation: KEMRI/Wellcome Trust Research Programme & University of Oxford

Key inclusion & exclusion criteria

Inclusion:

- Age 2 months to 13 years inclusive

- Severe malnutrition defined as:

- kwashiorkor at any age or:

- for children between 2 to 5 months: MUAC <11cm or weight-for length Z score <-3

- for children between 6 to 59 months: MUAC <11.5cm or weight-for length Z score <-3

- for children between 5 to 13 years: MUAC <11.5cm or BMI-for-age Z score <-3

- Admitted to hospital and eligible for intravenous antibiotics according to WHO
guidelines

- Planning to remain within the hospital catchment area and willing to come for
specified visits during the 90 day follow up period

- Informed consent provided by the parents/guardian

Exclusion:

- Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or
metronidazole

- A specific and documented clinical indication for another class of antibiotic

- Previously enrolled in this study



Age minimum: 2 Months
Age maximum: 13 Years
Gender: All

Health Condition(s) or Problem(s) studied

Antibiotic Resistance

Malnutrition Severe

Antibiotic Toxicity

Intervention(s)

Drug: Benzyl penicillin

Other: Placebo

Drug: Gentamicin

Drug: Ceftriaxone

Drug: Metronidazole

Primary Outcome(s)

Mortality [Time Frame: 90 days after enrolment.]

Secondary Outcome(s)

Mortality after discharge from index admission. [Time Frame: 90 days after enrolment]

Duration of administration of antibiotics. [Time Frame: 90 days after enrolment.]

Mortality during the first 30 days [Time Frame: 7 days]

Change in nutritional status [Time Frame: 90 days after enrolment.]

Mortality during the first 7 days [Time Frame: 7 days]

Duration of hospitalisation. [Time Frame: 90 days after enrolment.]

Faecal carriage of bacteria expressing Extended Spectrum Lactamase (ESBL) [Time Frame: Through study completion an average of 90 days.]

Grade 4 toxicity [Time Frame: Up to 7 days following enrolment]

Index admission inpatient mortality [Time Frame: Through index hospital admission, an average of 7 days.]

Serious adverse events [Time Frame: 90 days after enrolment.]

Tolerability - relevant side effects during the first 7 day [Time Frame: 7 days]

Causes of death. [Time Frame: 90 days after enrolment]

Re-admission to hospital. [Time Frame: From discharge from hospital to 90 days after enrolment]

Secondary ID(s)

1-17

105431/Z/14/Z

KEMRI/SERU/CGMR-C/063/3399

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

London School of Hygiene and Tropical Medicine

KEMRI-Wellcome Trust Collaborative Research Program

University College, London

Kenya Medical Research Institute

Swansea Trials Unit