Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children

PHASE4RecruitingINTERVENTIONAL
Enrollment

452

Participants

Timeline

Start Date

May 30, 2022

Primary Completion Date

May 16, 2028

Study Completion Date

May 16, 2028

Conditions
Complicated Urinary Tract InfectionInfectionPediatric Infectious Disease
Interventions
DRUG

Benzylpenicillin - single dose

"Participants will receive a single dose of IV antibiotic (benzylpenicillin).~Benzylpenicillin dosing: 1 month - 18 years, IV or Intramuscular (IM) 30 mg/kg (maximum 1.2 g) every 6 hours."

DRUG

Benzylpenicillin - three days

"Participants will receive three days of this IV antibiotic (benzylpenicillin).~Benzylpenicillin dosing: 1 month - 18 years, IV or Intramuscular (IM) 30 mg/kg (maximum 1.2 g) every 6 hours. For severe infections, use up to 60 mg/kg (maximum 2.4 g) every 4-6 hours."

DRUG

Gentamicin - single dose

"Participants will receive a single dose of IV antibiotic (gentamicin).~Gentamicin dosing: Children ≤10 years old: 7.5 mg/kg (maximum dose 320 mg) Children \>10 years old: 6-7 mg/kg (maximum dose 560 mg)"

DRUG

Gentamicin - three days

"Participants will receive three days of this IV antibiotic (gentamicin).~Gentamicin dosing: Children ≤10 years old: 7.5 mg/kg (maximum dose 320 mg) Children \>10 years old: 6-7 mg/kg (maximum dose 560 mg)"

DRUG

Cefalexin - post single dose of IV antibiotics for the remaining two days

Oral antibiotic will be as per local guidelines. i.e. Cefalexin 25mg/kg (maximum dosage 500mg) 4 times a day or 33mg/kg (maximum dosage 500mg) 3 times a day

Trial Locations (5)

1023

RECRUITING

Starship Children's Hospital, Auckland

3052

RECRUITING

Royal Children's Hospital, Parkville

3168

RECRUITING

Monash Health, Melbourne

6009

RECRUITING

Perth Children's Hospital, Perth

Unknown

RECRUITING

Women and Children's Hospital, Adelaide

All Listed Sponsors
collaborator

Royal Children's Hospital

OTHER

lead

Murdoch Childrens Research Institute

OTHER

NCT04876131 - Single Dose Intravenous Antibiotics for Complicated Urinary Tract Infections in Children | Biotech Hunter | Biotech Hunter