Early Oral Switch for Uncomplicated Gram-negative Bacteraemia

Exclusion Criteria

• •1. Established uncontrolled focus of infection, including but not limited to:
• •* 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
• •2. Complicated infections, including but not limited to:
• •* Necrotising fasciitis
• •* Empyema
• •* Central nervous system infections and meningitis
• •* Endocarditis / endovascular infections
• •3. 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
• •4. 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)
• •5. Bacteraemia is due to a vascular catheter or intravascular materials (e.g. pacing wire, vascular graft) that cannot be removed
• •6. Specific Gram-negative pathogens that cannot be effectively treated with fluoroquinolones or trimethoprim-sulfamethoxazole, including but not limited to, Burkholderia spp. and Brucella spp.
• •7. Index GNB with resistance to fluoroquinolones AND trimethoprim-sulfamethoxazole
• •8. Hypersensitivity to fluoroquinolones AND sulphur drugs as defined by history of rash, urticaria, angioedema, bronchospasm, circulatory collapse or significant adverse reaction following prior administration
• •9. Unable to consume or absorb oral medications for any reason or unsuitable for ongoing IV therapy (e.g. no intravenous access)
• •10. Severely immunocompromised in the opinion of the treating doctor, including but not limited to, medical conditions such as:
• •* Active leukaemia or lymphoma
• •* Aplastic anaemia
• •* Bone marrow transplant within two years of transplantation or transplants of longer duration still on immunosuppressive drugs or with graft-versus-host disease
• •* Congenital immunodeficiency
• •* HIV/AIDS with CD4 lymphocyte count \<200
• •* Neutropenia or expected post-chemotherapy neutropenia within 14 days from the time of screening, defined as absolute neutrophil count \< 500 cells/μL
• •11. Women who are known to be pregnant or breast-feeding
• •12. Treatment is not with intent to cure the infection (i.e. palliative care)
• •13. Unable to collect patient's follow-up data for at least 30 days post-randomisation for any reason
• •14. Treating doctor deems enrolment into the trial is not in the best interest of the patient
• •15. Previous enrolment in this trial