Actively Recruiting
Early Oral Switch for Uncomplicated Gram-negative Bacteraemia
Led by Tan Tock Seng Hospital · Updated on 2026-04-16
720
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
Sponsors
T
Tan Tock Seng Hospital
Lead Sponsor
N
National University Hospital, Singapore
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Early Oral Switch for Uncomplicated Gram-negative Bacteraemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- One or more blood cultures positive for Gram-negative bacteria showing infection
- Able to be randomized within 72 hours of initial blood culture collection
- Age 18 years or older (21 years or older in Singapore)
- Latest Pitt bacteraemia score less than 4
- Patient or legal representative can provide informed consent
You will not qualify if you...
- Uncontrolled infection focus needing surgery or unresolved abdominal sources
- Central nervous system abscess or infections including meningitis
- Undrained moderate-to-severe hydronephrosis
- Complicated infections such as necrotising fasciitis, empyema, endocarditis, or endovascular infections
- Septic shock despite fluid resuscitation or requiring inotropic/vasopressor support
- Polymicrobial bacteraemia involving Gram-positive or anaerobic pathogens
- Bacteraemia from vascular catheter or intravascular materials that cannot be removed
- Specific Gram-negative pathogens resistant to study antibiotics (e.g., Burkholderia spp., Brucella spp.)
- Resistance to both fluoroquinolones and trimethoprim-sulfamethoxazole
- Allergic reactions to fluoroquinolones and sulfur drugs
- Unable to take or absorb oral medications or unsuitable for IV therapy
- Severely immunocompromised conditions including active leukemia, lymphoma, aplastic anemia, recent bone marrow transplant, congenital immunodeficiency, HIV/AIDS with low CD4 count, or neutropenia
- Pregnant or breastfeeding women
- Treatment not intended to cure infection (palliative care)
- Unable to collect follow-up data for 30 days post-randomisation
- Treating doctor considers trial enrollment not in patient's best interest
- Previous enrollment in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tan Tock Seng Hospital
Singapore, Singapore, Singapore, 308433
Actively Recruiting
Research Team
D
David Lye, MBBS
CONTACT
I
I. Russel Lee, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here