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临床试验/CTRI/2024/02/063166
CTRI/2024/02/063166尚未招募不适用

An Observational Study for Antifungal Drug Prescription Pattern in Out Patient Department of Skin & VD, SMS Hospital, Jaipur

未提供1 个研究点 分布在 1 个国家目标入组 307 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
307
试验地点
1
主要终点
Percentage of prescriptions as per WHO prescribing indicators

研究概览

简要总结

•Skin is the largest organ and is the first protective barrier that is exposed to various environmental and chemical factors, as well as infections.

•Skin diseases affect almost 900 million people in the world at any time, are among the highest of all human diseases & the fourth leading cause of nonfatal disease burden worldwide.

•The earliest most common fungal infections which are Tinea Corporis (Ring-worm) and Tinea Cruris (Jock Itch).

•Fungal infections can affect the quality of life of affected individuals with significant impact on sleep patterns, emotions & social life.

•Currently, five common classes of antifungal drugs such as Azoles, Polyenes, Echinocandins, Allylamines and Pyrimidine analogs are available for superficial and systemic antifungal therapies.

•Among these, Azole class of drugs includes Imidazoles (Miconazole and Ketoconazole) and Triazoles (Fluconazole and Voriconazole) have been the most successful backbone.

•Large varieties of systemic as well as topical antifungal agents are available in the market. Some newer antifungal agents are flooding into the market in current days e.g. Eberconazole and Posaconazole.

•The WHO has developed three highly standardized core drug use indicators.5 These are prescribing indicators, patient care indicators, and facility indicators.

•Hence this study aims to evaluate the prescription pattern with distribution of fungal disease.

•Prescription of drugs requires expertise in diagnostics, an understanding of common medications and their therapeutic effects, adverse effects, and drug interactions, a grasp of the fundamentals of clinical pharmacology, communication abilities, and the capacity to weigh the pros and cons of treatment.

•In tropical countries like India, Fungal infections are more common and have increased in the last four decades due to environmental factors, increased use of broad spectrum antifungal agents and increasing prevalence of patients with immune deficiency states.

•Frequency of invasive fungal infections with the emergence of new species of pathogenic fungi have increased vastly, so rational use of antifungal drugs in clinical practice has important implications for patient care as it can facilitate their rational use for prophylaxis, empirical, pre-emptive & targeted treatment.

•The purpose of the present study is to understand the prescribing pattern of antifungal agents, their use will be standardized as per WHO prescribing indicators, also analyzing the factors such as the choice, dosages, treatment duration, and considerations of patient demographics and co-morbidities, which will enhance the rational use of antifungal drugs.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 79.00 Year(s)(—)
性别
All

入选标准

  • Patients who have been prescribed at least one antifungal drug.
  • Patients willing to give consent for participation in study.

排除标准

  • Patients having any skin infection other than fungal infection.
  • Psychiatric Patients with skin disorder and unable to give informed written consent with no attendants.

结局指标

主要结局

Percentage of prescriptions as per WHO prescribing indicators

时间窗: 6 Months

Correlation of antifungal use according to clinical profile of patients.

时间窗: 6 Months

Correlation of antifungal drug use according to sociodemographic profile of the patients.

时间窗: 6 Months

Percentage of concomitant drugs/ antimicrobials.

时间窗: 6 Months

Percentage of cases developing Adverse drug reactions (ADRs) to antifungal Drugs.

时间窗: 6 Months

次要结局

  • Adverse Drug Reaction(6 months)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Anil Kumar Sharma

Department of Pharmacology, SMS Medical College

研究点 (1)

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