Comparative study of procalcitonin guided early de-escalation versus conventional antimicrobial therapy in children with high-risk febrile neutropenia receiving cancer chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess the recurrence of fever within first 10 days of being afebrile after discharge among children receiving cancer chemotherapy and being treated for high risk febrile neutropenia
研究概览
简要总结
The study design will be a single-center, randomized, non-inferiority trial. The study will be conducted over 18 months period among children diagnosed with cancer and being managed under Department of Pediatrics, VMMC and Safdarjung Hospital, New Delhi. Children with high-risk febrile neutropenia will be admitted and started on iv antibiotics. The parents will be instructed to record temperature at least 3 times daily and also whenever the child is febrile and maintain a temperature record for review. The children will be reviewed again at 72 hours of starting empirical antibiotics and samples for PCT will be taken along with other investigations.Children will be randomized into two groups, after getting consent for the study. Intervention arm- Early de-escalation of empirical antibiotics from iv to oral (at 72 hours). Oral antibiotics will be continued until recovery of neutropenia i.e., ANC more than 500/microliter. Standard arm-Standard therapy with continuation of antibiotics until recovery of neutropenia which is ANC more than 500/microliter .Children belonging to both the groups will be followed clinically for recurrence of feverwithin first 10 days of being afebrile after discharge for primary and secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •All children aged 3-14 years with hematolymphoid malignancies (ALL on Intensive phase of chemotherapy, AML, NHL) on chemotherapy and presenting with high- risk Febrile neutropenia, started on empirical antimicrobial therapy will be enrolled at 96 hours of presentation when they fulfill the following criteria -Sterile blood culture at 48 boursNegative Procalcitonin value (less than 0.5ng/ml) or more than 80% reduction in Procalcitonin value from baseline at 72 hours.
- •With an afebrile period for at least 24 hours (without antipyretics)No evidence of marrow recovery (Absolute Neutrophil Counts less than 500 per microliter).
排除标准
- •Hemodynamically unstable at time of presentation Clinically documented infections/sepsis which require prolonged duration of antibiotics like pneumonia, septic arthritis, meningitis, osteomyelitis, Neutropenic enterocolitis.Microbiological evidence of infection (Blood culture showing growth of microorganism)
- •Radiological evidence of any focus of infection.
结局指标
主要结局
To assess the recurrence of fever within first 10 days of being afebrile after discharge among children receiving cancer chemotherapy and being treated for high risk febrile neutropenia
时间窗: Every 48 hours till 10 days of being afebrile after discharge or as per scheduled visits for chemotherapy or if danger signs appear
次要结局
- To compare the mean duration ofantibiotic exposure between the two groups(To compare the mean duration taken for ANC recovery (more than 500/microliter) between the two groups.)
研究者
Aditi Sharma
Vardhaman Mahavir Medical College, Safdarjung Hospital New Delhi 110029