Therapeutic and pharmacoeconomic comparison of 24-hours continuous infusion versus 2-hours intermittent infusion of meropenem in paediatric febrile neutropenia patients: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The primary outcome would be to monitor the duration of fever resolution and also the duration of neutropenia.
研究概览
简要总结
Febrile neutropenia (FN) is a frequent and serious complication in paediatric cancer patients receiving chemotherapy. Prompt administration of broad-spectrum antibiotics such as meropenem is critical to reduce morbidity and mortality. Emerging pharmacodynamic evidence indicates that extended or continuous infusion of meropenem may improve drug exposure (time above MIC), optimise clinical outcomes and limit resistance compared to standard intermittent infusion. However, current literature on paediatric data in resource-limited settings is inadequate to guide robust conclusions.
This single-centre, randomised controlled trial will compare 24-hour continuous infusion with 2-hour intermittent infusion of meropenem in paediatric patients with FN. Eligible participants will be randomised in a 1:1 ratio to either intervention arm. The primary endpoint is time to fever resolution. Secondary outcomes include duration of hospitalisation, clinical success rate, all-cause mortality, emergence of resistance, and cost of therapy. Microbiological evaluation will include culture and sensitivity testing with determination of minimum inhibitory concentration (MIC) for meropenem within 48 hours and on Day 5 of therapy to monitor susceptibility trends.
The findings of this trial are expected to provide evidence on the comparative effectiveness and cost-efficiency of meropenem infusion strategies in paediatric FN, support rational antibiotic use and contribute to antimicrobial stewardship practices in paediatric oncology settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •All paediatric patients aged below 18 years, diagnosed with any type of cancer.
- •Patients undergoing chemotherapy for both haematological malignancies and solid tumours.
- •Absolute neutrophil count (ANC) less than 500 cells per microlitre.
- •Patients who have a documented fever of more than or equal to 38.3°C (101°F) or more than or equal to 38°C (100.4°F) for more than one hour, unrelated to administration of blood products or pyrogenic substances.
- •Informed consent obtained from parents or guardians.
- •Prescribed meropenem administered either as a 24-hour continuous infusion or as a 2 hour intermittent infusion.
排除标准
- •Patients who refuse to provide informed consent by parent or legal guardian.
- •Prior or ongoing treatment with carbapenems or multiple broad-spectrum antibiotics before enrolment.
- •Known hypersensitivity or allergic reaction to meropenem or other carbapenem-class antibiotics.
- •Presence of severe renal or hepatic dysfunction, as determined by the treating physician.
- •Patients undergoing chemo-radiotherapy with bone marrow or peripheral stem cell transplantation.
结局指标
主要结局
The primary outcome would be to monitor the duration of fever resolution and also the duration of neutropenia.
时间窗: Within 7 days of starting therapy
次要结局
- The secondary outcome would be to assess the duration of hospitalization & to evaluate the mortality & survival rates.(During treatment period from day 0 to day 30)
- To record any adverse effects associated with the use of antibiotics & to track the development of any resistant bacterial strains in the study population.(During treatment period till day 30)
研究者
Prof Dr M S Ganachari
KLE College of Pharmacy Belagavi