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临床试验/CTRI/2018/03/012838
CTRI/2018/03/012838已完成不适用

Prescription audit of anti-fungal treatment of dermatophytoses in the Dermatology out patient department of a tertiary care hospital

Diamond Jubilee society trust1 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2015年1月30日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
370
试验地点
1
主要终点
To study the prescriptions of clinically diagnosed cases of dermatophytoses

研究概览

简要总结

Patients who were diagnosed with dermatophytoses infection in the Dermatology OPD, were recruited after obtaining their written informed consent or assent. These patients were followed up every 2 to 4 weeks for up to a total of 3 visits in case of treatment naive (New) patients and a total of 2 visits in case of patients already on anti-fungal therapy (Old cases). History of the patient was taken on the day of recruitment. The prescriptions were noted down at each visit. Clinical status was noted at each visit. Each patient was given a score of 0 to 3 for their symptoms of erythema, pruritus and desquamation based on their severity (Nil=0, Mild=1, Moderate=2, Severe=3). The patients were then categorised as clinically cured, clinical improvement and clinical failure groups. Blood samples for serum ALT levels were taken twice 2-4 weeks apart. In case of treatment naive patients, it was done on the 2nd and 3rd visits. In case of patients already on ongoing treatment, it was done on the 1st and 2nd visits. Availability of medications in the hospital pharmacy was checked at regular intervals. Patients who presented to the OPD for both the blood sample collection were considered to have completed the study.

Results:

Out of the 370 patients who were enrolled, 93 eventually completed the study. New and old cases constituted 46% and 54% of all patients respectively. The median age of patients was 33.5 years. The majority of patients (27.83%) belonged to the age group of 31-40 years. Males and females constituted 46% and 54% of the sample size respectively. The largest group of patients consisted of homemakers (34.86%) and students (18.64%). Tinea corporis constituted the highest number of cases (50.27%) followed by a combination of tinea corporis and tinea cruris (28.37%).

A total of 506 prescriptions were analysed. These included various formulations of anti-fungal drugs and anti-pruritic drugs. Azoles were the most commonly prescribed anti-fungal drug class. Clinical status of patients was independent of the oral anti-fungal drug prescribed. There was non-uniformity in the pharmacological management of patients who failed treatment. A statistically significant increase in serum ALT levels was seen (p<0.05) however, it was not clinically significant. About 55.52% drugs were unavailable in the hospital pharmacy during the entire duration of the study. This led to out-of -pocket expenses for patients. The average expenses per prescription for a duration of 3 weeks was INR 1123.55. Itraconazole regimen was found to be the most expensive for a duration of 3 weeks, followed by terbinafine and fluconazole.

研究设计

研究类型
Observational

入排标准

年龄范围
12.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1 Patients aged 12 to 65 years 2 Either genders 3 Newly diagnosed patients 4 Follow-up patients already on anti fungal therapy 5 Patients willing to give written informed consent and assent.

排除标准

  • 1 patients diagnosed with tinea unguium tinea capitis or Majocchi granuloma 2 Any other concomitant skin diseases such as psoriasis eczema etcetra 3 Other systemic illnesses being treated with drugs such as rifampicin phenytoin etcetra which may result in drug interactions.

结局指标

主要结局

To study the prescriptions of clinically diagnosed cases of dermatophytoses

时间窗: 4 to 8 weeks

次要结局

  • To evaluate treatment of clinical failure cases(To estimate rise in serum ALT levels)

研究者

申办方类型
Government medical college

研究点 (1)

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