First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition

PHASE3UnknownINTERVENTIONAL
Enrollment

2,000

Participants

Timeline

Start Date

September 4, 2017

Primary Completion Date

January 31, 2020

Study Completion Date

December 31, 2020

Conditions
Malnutrition SevereAntibiotic ResistanceAntibiotic Toxicity
Interventions
DRUG

Ceftriaxone

Ceftriaxone a third-generation cephalosporin. Ceftriaxone is active against a broad spectrum of Gram positive and Gram negative bacteria.

DRUG

Benzyl penicillin

The currently recommended first-line antibiotics for the treatment of severe acute malnutrition are gentamicin plus ampicillin or penicillin.

DRUG

Metronidazole

"The WHO guidelines recommend that Metronidazole may be given in addition to broad-spectrum antibiotics, however, the efficacy of this treatment has not been established in clinical trials."

OTHER

Placebo

Suspension manufactured to match metronidazole

DRUG

Gentamicin

The currently recommended first-line antibiotics for the treatment of severe acute malnutrition are gentamicin plus ampicillin or penicillin.

Trial Locations (8)

80108

Kemri Wellcome Trust Research Programme, Kilifi

Kilifi County Hospital, Kilifi

80800

KEMRI WT Clinical Trials Facility, Kilifi

Unknown

Kilifi County Hospital, Kilifi

Coast General Hospital - Study site, Mombasa

Mbagathi District Hospital, Nairobi

Mbagathi Hospital, Nairobi

Mbale Regional Referral Hospital, Mbale

Sponsors
All Listed Sponsors
collaborator

University College, London

OTHER

collaborator

London School of Hygiene and Tropical Medicine

OTHER

collaborator

Swansea Trials Unit

UNKNOWN

collaborator

Kenya Medical Research Institute

OTHER

collaborator

KEMRI-Wellcome Trust Collaborative Research Program

OTHER

lead

University of Oxford

OTHER