Early Oral Step-down Antibiotic Therapy for Uncomplicated Gram-negative Bacteraemia

PHASE4RecruitingINTERVENTIONAL
Enrollment

720

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

March 1, 2025

Study Completion Date

June 1, 2025

Conditions
Gram-negative Bacteraemia
Interventions
DRUG

Oral fluoroquinolones (most commonly, ciprofloxacin) or oral trimethoprim-sulfamethoxazole

Clinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia randomised to the intervention arm will be switched early to oral antibiotics (within 72 hours from index blood culture collection)

DRUG

Standard of care intravenous antibiotics (e.g. ceftriaxone, cefazolin)

Clinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia randomised to the standard arm will continue to receive an active intravenous antibiotic therapy for at least another 24 hours post-randomisation before clinical re-assessment and decision making by the treating doctor

Trial Locations (1)

308433

RECRUITING

Tan Tock Seng Hospital, Singapore

All Listed Sponsors
collaborator

Singapore Clinical Research Institute, Singapore

UNKNOWN

collaborator

National University Hospital, Singapore

OTHER

collaborator

Singapore General Hospital

OTHER

collaborator

Changi General Hospital

OTHER

collaborator

Ng Teng Fong General Hospital, Singapore

UNKNOWN

collaborator

Sengkang General Hospital, Singapore

UNKNOWN

collaborator

Royal Brisbane and Women's Hospital, Australia

UNKNOWN

collaborator

Royal Melbourne Hospital, Australia

UNKNOWN

collaborator

University Malaya Medical Centre, Malaysia

UNKNOWN

collaborator

Samsung Medical Center, South Korea

UNKNOWN

collaborator

Princess Alexandra Hospital, Australia

UNKNOWN

collaborator

Gold Coast University Hospital, Australia

UNKNOWN

collaborator

Ampang Hospital, Malaysia

UNKNOWN

collaborator

Sungai Buloh Hospital, Malaysia

UNKNOWN

collaborator

Universiti Kebangsaan Medical Centre, Malaysia

UNKNOWN

collaborator

Medipol Mega University Hospital, Turkey

UNKNOWN

collaborator

Rambam Hospital, Israel

UNKNOWN

collaborator

Sheba Medical Centre, Israel

UNKNOWN

collaborator

IRCCS Policlinico di Sant'Orsola, University Alma Mater Studiorum of Bologna, Italy

UNKNOWN

collaborator

Monaldi Hospital, Italy

UNKNOWN

collaborator

University Hospital of Pisa, Italy

UNKNOWN

collaborator

IRCCS San Raffaele

OTHER

collaborator

University General Hospital of Patras, Greece

UNKNOWN

collaborator

Hospital del Mar, Parc de Salut MAR, Spain

UNKNOWN

collaborator

American University of Beirut Medical Center

OTHER

lead

Tan Tock Seng Hospital

OTHER