跳至主要内容
临床试验/CTRI/2018/10/016073
CTRI/2018/10/016073招募中不适用

A prospective observational study to evaluate the clinical utility of staged Broncho alveolar fluid (BAL) analysis in adolescent and adult leukemia and lymphoma patients with febrile neutropenia and lung infiltrates.

Tata Memorial Centre Research Administrative Council1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年10月24日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
The proportion of patients with a confirmed microbiological diagnosis using staged BAL analysis

研究概览

简要总结

Febrile neutropenia (FN) is an important complication while on chemotherapy in patients with hematological malignancies. Lung infiltrates (LI) are seen in 30% of patients with FN. The prevalence of LI depends on the duration of neutropenia, underlying malignancy and the imaging modality used (CT chest being more sensitive as compared to Chest X rays). Patients of FN with LI have a higher mortality. A wide spectrum of organisms can cause LI in this setting and includes bacterial, fungal, viral or poly-microbial infections. Treatment is mostly empirical and usually consists of a combination of antibiotics that cover Enterobacteriaceae and Pseudomonas (Such as Cefoperazone-sulbactam or carbapenems) with an aminoglycoside and an agent that act against staphylococcal aureus (Teicoplanin or vancomycin). The addition of antifungal is considered if fever persists beyond 96 hours as per the IDSA guidelines. The antibiotics are continued for at least 10-14 days and in the case of an antifungal for throughout the duration of myelosuppression and resolution of radiological findings. The radiological findings are non-specific. Other non-invasive tests such as blood cultures and serum galactomannan help in guiding therapy in <30% patients. An accurate etiological diagnosis is essential and could help in narrowing down the use of antimicrobials, thereby improving the efficacy, preventing toxicity and emergence of drug resistance. Bronchoscopy is an important diagnostic tool that has a diagnostic yield reported in the range of 25-50%. These studies have been mainly retrospective in nature and used a varied microbiologic algorithm. The studied population has also been very heterogeneous precluding any firm conclusion on its clinical utility. This also has to be looked at in the context that most of the FN patients have a higher risk of complications such as bleeding (due to thrombocytopenia and coagulopathy) due to the procedure. These patients are also sick and could be dependent on high flow oxygen or hemodynamically unstable thereby making them unsuitable for this procedure. We routinely perform BAL analysis on patients of FN with LI and use a microbiologic algorithm tapered to the clinical presentation and radiological findings and have found it very useful. The exact clinical utility and feasibility of this test need to be studied in a prospective manner, we propose to do in our study.

研究设计

研究类型
Observational

入排标准

年龄范围
15.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients aged more than or equal to 15years Leukemia and lymphomas on chemotherapy Febrile neutropenia Lung infiltrates on chest x-ray or CT chest.

排除标准

  • 未提供

结局指标

主要结局

The proportion of patients with a confirmed microbiological diagnosis using staged BAL analysis

时间窗: 24 hour

次要结局

  • a) The proportion of patients who have a change in antimicrobial therapy.(b) The feasibility of doing a Bronchoscopy.)

研究者

发起方
Tata Memorial Centre Research Administrative Council
申办方类型
Research institution and hospital

研究点 (1)

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