Early Oral Switch for Uncomplicated Gram-negative Bacteraemia

Summary

Current management of uncomplicated Gram-negative bacteraemia entails prolong intravenous (IV) antibiotic therapy with limited evidence to guide oral conversion. This trial aim to evaluate the clinical efficacy and economic impact of early switch to oral antibiotics (within 72 hours from index blood culture collection) versus continuing standard of care IV therapy (for at least another 24 hours post-randomisation) for clinically stable / non-critically ill inpatients with uncomplicated Gram-negative bacteraemia.

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 immediately be switched 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

Sponsors & Collaborators

• National University Hospital, Singapore

  collaborator OTHER

• Singapore General Hospital

  collaborator OTHER

• Changi General Hospital

  collaborator OTHER

• Sengkang General Hospital

  collaborator OTHER

• Ng Teng Fong General Hospital

  collaborator OTHER

• University of Malaya

  collaborator OTHER

• KPJ Ampang Puteri Specialist Hospital

  collaborator OTHER_GOV

• Hospital Sungai Buloh, Selangor

  collaborator UNKNOWN

• Universiti Kebangsaan Malaysia Medical Centre

  collaborator OTHER

• Taichung Veterans General Hospital

  collaborator OTHER

• Melbourne Health

  collaborator OTHER

• Gold Coast Hospital and Health Service

  collaborator OTHER_GOV

• Princess Alexandra Hospital, Brisbane, Australia

  collaborator OTHER

• Istanbul Medipol University Hospital

  collaborator OTHER

• Rambam Hospital, Haifa, Israel

  collaborator UNKNOWN

• Sheba Medical Center

  collaborator OTHER_GOV

• University Hospital of Pisa

  collaborator UNKNOWN

• IRCCS San Raffaele

  collaborator OTHER

• IRCCS Azienda Ospedaliero-Universitaria di Bologna

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• American University of Beirut Medical Center

  collaborator OTHER

• University Hospital of Patras

  collaborator OTHER

• Hospital del Mar

  collaborator OTHER

• Singapore Clinical Research Institute

  collaborator OTHER

• Consorzio per Valutazioni Biologiche e Farmacologiche

  collaborator OTHER

• Tan Tock Seng Hospital

  lead OTHER

Principal Investigators

• David Lye, MBBS · Tan Tock Seng Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-06-03

Primary Completion

2026-05-31

Completion

2026-07-31

Countries

• Singapore

Study Locations