Role of Oral Voriconazole in the Treatment of Resistant Dermatophyte Infections

Официальное название

Comparing the Efficacy of Oral 200 Milligram Voriconazole Once a Day Vs. Twice a Day in the Treatment of Resisitant Dermatophyte Infections (Tinea Corporis and Tinea Cruris)

Обзор

Treatment of dermatophyte infection in our country (Pakistan) is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness ,feasibility and standard dosage of a newer antifungal drug like voriconazole is the need of the hour in resistant cases of dermatophyte infection.

Подробное описание

Treatment of dermatophyte infection in our country is becoming difficult due to the developing resistance to traditional antifungal agents. Assessing the effectiveness and feasibility of a newer antifungal drug like voriconazole is the need of the hour in resistant cases.

Objective: To compare the efficacy of oral 200 milligram voriconazole once a day vs twice a day in the treatment of resistant dermatophyte infections (tinea corporis and cruris).

Material \& Methods: This randomized controlled trial using non-probability sampling technique will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval from ethical review committee of the hospital has been taken. Total 106 patients will be divided into two groups, Group A and Group B, each consisting of 53 patients. Group A will be given oral voriconazole 200mg once a day and Group B will be given twice a day for a maximum of 28 days. Efficacy will be assessed at day 14 and day 28, and relapse will be noted at the 2-month follow-up visit. Data will be recorded on a preformed Proforma for each patient and wiil be analyzed using SPSS 24. A p-value of less than 0.05 will be considered statistically significant.

Вмешательства

• Препарат Voriconazole high dose
  Oral voriconazole 200mg once a day for a maximum of 28 days
• Препарат Voriconazole low dose
  Oral voriconazole 200mg twice a day for a maximum of 28 days

Первичные конечные точки

• Efficacy of oral voriconazole 200 mg once daily(low dose) vs. twice daily (high dose) [Срок оценки: Clinical assessment for efficacy will be done at day 14 and day 28]

Критерии участия

Критерии включения

• Resistant cases of tinea cruris and tinea corporis: Those cases who received the standard dosage of oral antifungals i.e. oral terbinafine 5mg/kg per day for 4 weeks or oral itraconazole 5mg per/kg/day for 4 weeks but they did not recover from the infection.
• Skin area: Groin and trunk
• Total diameter of the lesions: 5cm to 80 cm

Критерии исключения

• History of hypersensitivity to azoles
• All those individuals having immunocompromised state (malignancy, tuberculosis, AIDS, history of organ transplant and history of immunosuppressive drug treatment etc.)
• Patients of diabetes, liver or kidney disease.
• Lactating mother
• Pregnant female

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Sheikh zayed Medical College and Hospital — Rahim Yar Khan

Идентификаторы

NCT: NCT06680544 · SZMC/H

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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