ISRCTN84288963已完成4 期
Early switch to oral antibiotic therapy in patients with low risk neutropenic sepsis: a randomised, controlled, non-inferiority trial with allocation concealment
Belfast Health and Social Care Trust (UK)0 个研究点目标入组 129 人开始时间: 2015年7月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
研究概览
简要总结
2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32460818/ protocol (added 29/05/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 05/04/2019:
- •1. Age over 16 years
- •2. Receiving SACT for a diagnosis of cancer
- •3. Started on empirical intravenous piperacillin/tazobactam or meropenem, for suspected NS, for less than 24 hours. Patients who have been started on additional antimicrobial drugs (eg. 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.
- •4. Absolute neutrophil count =1.0x109/L with either a temperature of at least 38oC 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 medical notes and is within 24 hours prior to IV antibiotic administration.
- •5. Expected duration of neutropenia <7 days
- •6. Low risk of complications using a validated risk score (MASCC score =21)
- •7. Able to maintain adequate oral intake and take oral medication
- •8. Adequate hepatic (AST &/or ALT <5xULN) and renal function (serum creatinine <3 x ULN) within the 24 hours prior to randomisation
- •9. 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 CSF is not an exclusion criterion if prescribed routinely as an integral component of a specific SACT regimen.
- •Previous inclusion criteria:
- •1. Age over 16 years
- •2. Receiving SACT for a diagnosis of cancer
- •3. Fever (temperature >38oC)
- •4. Neutropenia (absolute neutrophil count =0.5x109/L) within the 24 hours prior to randomisation
- •5. Received intravenous antibiotics (piperacillin/tazobactam or meropenem) for less than 24 hours
- •6. Expected duration of neutropenia <7 days
- •7. Low risk of complications using a validated risk score (MASCC score =21)
- •8. Able to maintain adequate oral intake and take oral medication
- •9. Adequate hepatic (AST and/or ALT <2.5xULN, or <5xULN if hepatic metastases) and renal function (serum creatinine <3xULN) within 24 hours prior to randomisation
- •10. 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)
排除标准
- •Current exclusion criteria as of 05/04/2019:
- •1. Underlying diagnosis of acute leukaemia or haematopoietic stem cell transplant
- •2. Hypotension (systolic pressure <90mmHg or reduction of >40mmHg from known baseline on >1 measurement) within the 24 hours prior to randomisation
- •3. Prior allergy, serious adverse reaction, or contra-indication to any study drug
- •4. Enrolled in this trial with prior episode of neutropenic sepsis
- •5. Previously documented as being colonised with an organism resistant to a study drug regimen e.g. MRSA
- •6. Localising signs of severe infection (pneumonia, soft tissue infection, central-venous access device infection, presence of purulent collection)
- •7. Patients unable to provide informed consent
- •8. Pregnant women, women who have not yet reached the menopause (no menses for = 12 months without an alternative medical cause) who test positive for pregnancy, are unwilling to take a pregnancy test prior to trial entry or are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial
- •9. Breastfeeding women
- •Previous exclusion criteria:
- •1. Underlying diagnosis of acute leukaemia or haematopoietic stem cell transplant
- •2. Hypotension (systolic pressure <90 mmHg) within the 24 hours prior to randomisation
- •3. Prior allergy, serious adverse reaction, or contra-indication to any study drug
- •4. Treatment with fluoroquinolone or penicillin antibiotics in the preceding 14 days
- •5. Enrolled in this trial with prior episode of neutropenic sepsis
- •6. Previously documented as being colonised with an organism resistant to a study drug regimen e.g. MRSA
- •7. Localising signs of severe infection (pneumonia, soft tissue infection, central-venous access device infection, presence of purulent collection)
- •8. Patients unable to provide informed consent
- •9. Pregnant women, women who have not yet reached the menopause (no menses for = 12 months without an alternative medical cause) who test positive for pregnancy, are unwilling to take a pregnancy test prior to trial entry or are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial
- •10. Breastfeeding women
研究者
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