Fosfomycin Versus Standard of Care in Children With Antibiotic-resistant Urinary Tract Infections

PHASE3RecruitingINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

August 2, 2023

Primary Completion Date

August 31, 2027

Study Completion Date

August 31, 2027

Conditions
Urinary Tract Infections
Interventions
DRUG

Fosfomycin

"Fosfomycin trometamol is a white crystalline powder which is very soluble in water. The granules are mixed with 90ml of cool water for the constitution to dissolve and will be administered soon after reconstitution. Each 30ml will contain 1g fosfomycin base.~* Children ≥ 6 months to \<1 year old will be administered 30ml (=1g fosfomycin base) of dissolved solution and the remainder discarded for each dose.~* Children ≥ 1 to 11 years will be administered 60ml (=2g fosfomycin base) of dissolved solution and the remainder discarded for each dose.~* Children ≥12 and \<18 years will be administered the entire 90ml solution (= 3g fosfomycin base) for each dose."

DRUG

Standard of care antibiotics

Standard of care antibiotics will be chosen by the treating clinician according to institutional prescribing practices, local antibiograms and medication availability.

Trial Locations (5)

2031

RECRUITING

Sydney Childrens Hospital, Sydney

2145

NOT_YET_RECRUITING

The Children's Hospital at Westmead, Sydney

3052

RECRUITING

Royal Childrens Hospital, Melbourne

4101

RECRUITING

Queensland Children's Hospital, Brisbane

6000

RECRUITING

Perth Children's Hospital, Perth

All Listed Sponsors
lead

University of Sydney

OTHER