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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
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Complicated infections, including but not limited to:
- Necrotising fasciitis
- Empyema
- Central nervous system infections and meningitis
- Endocarditis / endovascular infections
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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
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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)
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Bacteraemia is due to a vascular catheter or intravascular materials (e.g. pacing wire, vascular graft) that cannot be removed
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Specific Gram-negative pathogens that cannot be effectively treated with fluoroquinolones or trimethoprim-sulfamethoxazole, including but not limited to, Burkholderia spp. and Brucella spp.
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Index GNB with resistance to fluoroquinolones AND trimethoprim-sulfamethoxazole
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Hypersensitivity to fluoroquinolones AND sulphur drugs as defined by history of rash, urticaria, angioedema, bronchospasm, circulatory collapse or significant adverse reaction following prior administration
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Unable to consume or absorb oral medications for any reason or unsuitable for ongoing IV therapy (e.g. no intravenous access)
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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
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Women who are known to be pregnant or breast-feeding
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Treatment is not with intent to cure the infection (i.e. palliative care)
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Unable to collect patient's follow-up data for at least 30 days post-randomisation for any reason
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Treating doctor deems enrolment into the trial is not in the best interest of the patient
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Previous enrolment in this trial
