Early Oral Switch for Uncomplicated Gram-negative Bacteraemia (NCT05199324) | Clinical Trial Compass
RecruitingPhase 4
Early Oral Switch for Uncomplicated Gram-negative Bacteraemia
Singapore720 participantsStarted 2022-06-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
✓. Patient or legal representative is able to provide informed consent
Exclusion criteria
✕. Established uncontrolled focus of infection, including but not limited to:
✕. Complicated infections, including but not limited to:
✕. Septic shock as defined by systolic blood pressure \<90 or mean arterial pressure \<70 mmHg despite adequate fluid resuscitation or need for inotropic/vasopressor support
✕. Polymicrobial bacteraemia involving Gram-positive pathogens or anaerobes (defined as either growth of 2 or more different microorganism species in the same blood culture, or growth of different species in 2 or more separate blood cultures within the same episode \[\<48 hours\] and with clinical or microbiological evidence of the same source)
✕. Bacteraemia is due to a vascular catheter or intravascular materials (e.g. pacing wire, vascular graft) that cannot be removed
✕. Specific Gram-negative pathogens that cannot be effectively treated with fluoroquinolones or trimethoprim-sulfamethoxazole, including but not limited to, Burkholderia spp. and Brucella spp.
✕. Index GNB with resistance to fluoroquinolones AND trimethoprim-sulfamethoxazole
✕. Hypersensitivity to fluoroquinolones AND sulphur drugs as defined by history of rash, urticaria, angioedema, bronchospasm, circulatory collapse or significant adverse reaction following prior administration