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Table 2 Current trial eligibility criteria

From: Early switch from intravenous to oral antibiotic therapy in patients with cancer who have low-risk neutropenic sepsis (the EASI-SWITCH trial): study protocol for a randomised controlled trial

Eligibility criteria

Inclusion criteria

  (i)

Age over 16 years

  (ii)

Receiving SACT for a cancer diagnosis

  (iii)

Started on empirical IV piperacillin/tazobactam or meropenem, for suspected NS, for less than 24 h. Patients who have been started on additional antimicrobial drugs (e.g., gentamicin or teicoplanin) are eligible, provided the physician in charge of their care is willing to stop this additional antimicrobial at the time of enrolment

  (iv)

Absolute neutrophil count ≤ 1.0 × 109/L with either a

Temperature of at least 38 °C or

Other signs or symptoms consistent with clinically significant sepsis, e.g., hypothermia.

Self-measurement at home or earlier hospital assessment of temperature are acceptable provided this is documented in the medical notes and is within 24 h prior to IV antibiotics administration.

  (v)

Expected duration of neutropenia < 7 days

  (vi)

Low risk of complications using a validated risk score (MASCC ≥ 21)

  (vii)

Able to maintain adequate oral intake and take oral medication

  (viii)

Adequate hepatic (AST+/ALT < 5x upper limit of normal (ULN)) and renal function (serum creatinine < 3x ULN) within the 24 h prior to randomisation

  (ix)

Physician in charge of care willing to follow either the intervention or standard care protocol per randomisation, at enrolment, including not treating with colony-stimulating factor (CSF). Prophylactic use of CSF is not an exclusion criteria if prescribed routinely as an integral component of a specific SACT regimen.

Exclusion criteria

  (i)

Underlying diagnosis of acute leukaemia or haematopoietic stem cell transplant

  (ii)

Hypotension (systolic pressure < 90 mmHg or reduction of > 40 mmHg from known baseline on > 1 measurement) within the 24 h prior to randomisation

  (iii)

Prior allergy, serious adverse reaction, or contraindication to any study drug

  (iv)

Enrolled in the trial with prior episode of neutropenic sepsis

  (v)

Previously documented as being colonised with an organism resistant to a study drug regimen, e.g., MRSA (methicillin-resistant Staphylococcus aureus)

  (vi)

Localising signs of severe infection (pneumonia, soft tissue infection, central venous access device infection, presence of purulent collection)

  (vii)

Patient unable to provide informed consent

  (viii)

Pregnant or breastfeeding women