Implementing an empirical antibiotic discontinuation strategy in adult haematological malignancies with high-risk febrile neutropenia without identifiable focus: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- JIPMER
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the number of successful episodes of discontinuation of
研究概览
简要总结
Febrile neutropenia is a common complication arising in cancer patients during course of chemotherapy. Febrile neutropenia poses a significant challenge in the management of high-risk patients, often requiring broad-spectrum antibiotic therapy.1 The choice of agents are modified as further investigations reveal any specific organism and, or depending on the clinical assessment of the patient. In a large number of cases, no definite focus of infection can be identified. The optimal management approach (duration or inpatient /outpatient setting) is still debatable.
It is quite common practice to continue empirical antimicrobial therapy (EAT) until neutrophil recovery which could prolong the therapy unnecessarily. 2
Optimization of antimicrobial therapy is necessary in an era of growing antimicrobial resistance, particularly important in management of patients with hematological malignancies on chemotherapy as they are often exposed to the collateral damage of prolonged broad-spectrum antimicrobial therapy including drug toxicity and predisposition to fungal infections and Clostridium difficile-associated diarrhea.3,4,5
To reduce side effects, antibiotic selective pressure on the human microbiota, and antimicrobial resistance development, a more rational use of antibiotics is necessary. 6
Therefore, if safe, stopping antibiotic therapy earlier in patients without signs of a bacterial infection could provide significant benefits.
We aimed to establish whether discontinuation of EAT driven by an integrated approach regardless of neutrophil recovery would optimize the duration of antibiotic therapy.
Rationale: The extended use of antibiotics contributes to:
1. Antimicrobial resistance
2. Adverse effects
3. Ineffective man-hour usage especially in low resource setting
4. Excessive cost
Hence, we want to explore antibiotic discontinuation policy in high-risk febrile neutropenia without focus in adult malignancy.
Novelty: Paucity of prospective studies assessing safety of discontinuation of antibiotics in high-risk febrile neutropenia cases in Indian settings among adult patients with malignancy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients with adult haematological malignancies, aged 18 years and above, with high-risk febrile neutropenia (expected ANC < 100) without focus on first-line antibiotic therapy admitted under medical oncology department, JIPMER.
排除标准
- •Previous enrolment on the trial • Age greater than or equal to 70 years • Patients who required therapeutic anti-fungals during febrile neutropenia • Patients who required more than first line (cefoperazone- sulbactam + amikacin, levofloxacin or any oral antibiotics) and second line antibiotics (cefoperazone- sulbactam+meropenem/imipenem+teicoplanin/clindamycin) • Patients who required inotropic support/mechanical ventilation during treatment course for febrile neutropenia • Severe renal function impairment (defined as creatinine clearance below 30 ml/ min) • Clinical or microbiological or radiologic focus of infection • Patient undergone stem cell transplant.
结局指标
主要结局
To assess the number of successful episodes of discontinuation of
时间窗: 72 hour
empirical antibiotic therapy among haematological malignancy
时间窗: 72 hour
patients with high-risk febrile neutropenia (expected ANC 100)
时间窗: 72 hour
without focus
时间窗: 72 hour
次要结局
- EAT-free duration (assuming that the antibiotics would have(been continued till neutrophil recovery of 500 cu mm).)
- Proportion with morbidity (either a relapse of fever or(development of new infection within 7 days of antibiotic)
- Proportion with complications (hypotension leading to fluid(bolus or ICU admission on therapy or within 7 days of)
- To assess the 30-day mortality(30 DAYS)
- Utility of biomarkers (Procalcitonin) in the discontinuation of(antibiotics)
研究者
SWAMINATHAN K
Jawaharlal Institute of Postgraduate Medical Education & Research (JIPMER)