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Early Oral Switch for Uncomplicated Gram-negative Bacteraemia

NCT05199324 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 720

Last updated 2026-08-10

No results posted yet for this study

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

  • 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
2026-05-24
Completion
2026-07-23

Countries

  • Australia
  • Greece
  • Israel
  • Italy
  • Lebanon
  • Malaysia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05199324 on ClinicalTrials.gov