Early Oral Switch for Uncomplicated Gram-negative Bacteraemia
ConditionGram-negative Bacteraemia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTan Tock Seng Hospital
About this trial
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.
Eligibility criteria
Qualifiers
One or more set(s) of blood cultures positive for Gram-negative bacteria (GNB) associated with evidence of infection
Able to be randomised within 72 hours of index blood culture collection
Age ≥18 years (≥21 in Singapore)
Latest Pitt bacteraemia score <4
Disqualifiers
Undrained abdominal abscess, deep seated intra-abdominal infection and other unresolved abdominal sources requiring surgical intervention
Central nervous system abscess (patients with focal neurology should have cranial CT prior to enrolment)
Undrained moderate-to-severe hydronephrosis
Necrotising fasciitis
Trial design
Treatments tested in this trial
- Oral fluoroquinolones (most commonly, ciprofloxacin) or oral trimethoprim-sulfamethoxazole
- Standard of care intravenous antibiotics (e.g. ceftriaxone, cefazolin)
Treatment groups
720 Participants
are divided into 2 treatment groupsSponsors and collaborators
Tan Tock Seng Hospital
Lead sponsor
National University Hospital, Singapore
Collaborator
Singapore General Hospital
Collaborator
Changi General Hospital
Collaborator
Sengkang General Hospital
Collaborator
Ng Teng Fong General Hospital
Collaborator
University of Malaya
Collaborator
KPJ Ampang Puteri Specialist Hospital
Collaborator
Hospital Sungai Buloh, Selangor
Collaborator
Universiti Kebangsaan Malaysia Medical Centre
Collaborator
Taichung Veterans General Hospital
Collaborator
Melbourne Health
Collaborator
Gold Coast Hospital and Health Service
Collaborator
Princess Alexandra Hospital, Brisbane, Australia
Collaborator
Istanbul Medipol University Hospital
Collaborator
Rambam Health Care Campus
Collaborator
Sheba Medical Center
Collaborator
University Hospital of Pisa
Collaborator
IRCCS San Raffaele
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
Seoul National University Bundang Hospital
Collaborator
Samsung Medical Center
Collaborator
American University of Beirut Medical Center
Collaborator
University Hospital of Patras
Collaborator
Hospital del Mar
Collaborator
Singapore Clinical Research Institute
Collaborator
Consorzio per Valutazioni Biologiche e Farmacologiche
Collaborator
Source ClinicalTrials.gov