跳至主要内容
临床试验/CTRI/2018/05/013733
CTRI/2018/05/013733招募中不适用

Antifungal Drug Utilization in Selected Clinical Care Settings of a Tertiary Care Teaching Hospital

KEM Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
KEM Hospital
入组人数
100
试验地点
1
主要终点
b. Appropriateness of antifungal use

研究概览

简要总结

Documentation and analysis of use of antifungal therapy and its related adverse events (AE)/adverse drug reactions (ADRs) mainly aims at promotion of rational and safe use of antifungal agents for invasive fungal infections. Considering the complexity of diagnosis, high costs of therapy and high morbidity and mortality associated with systemic fungal infections, antifungal therapy should follow clearly defined guidelines.

Systemic antifungal treatments are very expensive, and are generally prescribed for a long duration. Routine and/or irrational use of drug regimens may expose a substantial portion of these patients to problems such as treatment failure, drug interactions and high risk of adverse events. In terms of successful therapy, current antifungal efficacy is limited by late diagnosis, limited diagnostic facilities, inadequate efficacy for many infections, adverse events and increasing rates of acquired resistance.

A careful antifungal stewardship programme in a tertiary care teaching hospital is essential to monitor these therapies in terms of extent and appropriateness of prescription, and to rationalize the use of these highly expensive drugs. So, the current prospective observational study will highlight the extent of use, adverse events, resistance pattern & eventually the overall prescription pattern of antifungal agents (AFAs) in selected clinical care setup such as MICU, PICU & Haematology ward.

This study will attempt to include about 100 patients admitted in Medical Intensive Care Unit (MICU)/Pediatric Intensive Care Unit (PICU)/Haematology ward & receiving Antifungal Therapy as a part of their treatment, over a period of 15 months. After approval from IEC and obtaining written ICD from the patients and/or LAR, data will be collected, and noted down in CRF. Evaluation of use will be on the basis of extent i.e. incidence of use as well as appropriateness. AE/ADR(s), if any, occurring in these patients will be recorded as per Central Drug Control Standard Organization (CDSCO) norms and later analyzed using WHO-UMC scale, Naranjo algorithm, modified Hartwig-Siegel scale, Schumock and Thornton scale.

研究设计

研究类型
Observational

入排标准

年龄范围
28.00 Day(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients admitted in either MICU, PICU or in Hematology ward and receiving antifungal drugs as a part of his/her treatment.
  • Patients or LAR willing to give informed consent.

排除标准

  • Re-consent refusal from patient, after regaining consciousness when admitted in unconscious state
  • Patients receiving prophylactic antifungal therapy.

结局指标

主要结局

b. Appropriateness of antifungal use

时间窗: a. extent of use of antifungal drugs Prescribed Daily Doses (PDDs) & Duration Of Therapy (DOTs) | b. Appropriateness of antifungal use

a. extent of use of antifungal drugs Prescribed Daily Doses (PDDs) & Duration Of Therapy (DOTs)

时间窗: a. extent of use of antifungal drugs Prescribed Daily Doses (PDDs) & Duration Of Therapy (DOTs) | b. Appropriateness of antifungal use

次要结局

  • a. Total number of adverse events occurring in patients receiving antifungal drugs(d. Percentage of adverse reactions causally related to AFAs: according to WHO-UMC or Naranjo algorithm)

研究者

发起方
KEM Hospital
申办方类型
Government medical college

研究点 (1)

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