Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD)

PHASE2TerminatedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

August 13, 2021

Primary Completion Date

December 31, 2023

Study Completion Date

December 31, 2023

Conditions
Crohn DiseasePediatric Crohns Disease
Interventions
DRUG

Azithromycin

Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks

DRUG

Metronidazole

Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks

OTHER

Standard of Care

SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.

Trial Locations (5)

15224

University of Pittsburgh Medical Center, Children's Hospital of Pittsburgh, Pittsburgh

94158

UCSF Benioff Children's Hospital, San Francisco

Unknown

IWK Health Centre, Halifax

Wolfson Medical Centre, Tel Aviv

Amsterdam UMC, Amsterdam

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Crohn's and Colitis Foundation

OTHER

collaborator

University of Amsterdam

OTHER

collaborator

OM Pharma SA

INDUSTRY

lead

University of North Carolina, Chapel Hill

OTHER

NCT04186247 - Personalized AZithromycin/metronidAZole Therapy in Pediatric Crohn's Disease (CD) | Biotech Hunter | Biotech Hunter