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临床试验/CTRI/2023/03/050237
CTRI/2023/03/050237尚未招募Unknown

Comparison of efficacy and safety of monthly intravenous methylprednisolone pulse therapy, versus daily oral Prednisolone in children with Allergic BronchoPulmonary Aspergillosis: A pilot, open label, randomized trial

Post Graduate Institute of Medical Education and Research0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
尚未招募
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • Group A (Intervention): Intravenous methylprednisolone 10 mg/kg/day for 3 consecutive days each month, for a total of 4 months will be administered after admission in the Pediatric Pulmonology Unit of the Advanced Pediatrics Centre, PGIMER Chandigarh. In addition, oral itraconazole 5 mg/kg/day will be administered for a total of 16 weeks.
  • Group B (Comparison): Oral prednisolone 0.5 mg/kg/day for 2 weeks, followed by 0.5mg/kg on alternate days for 8 weeks, followed by slow tapering (5 mg two weekly) over 8 weeks. In addition, oral itraconazole 5 mg/kg/day will be administered for a total of 16 weeks.

排除标准

  • 1-Children who received systemic corticoids( any preparation, any dose, any route) for more thane weeks in the preceding 6 month.
  • 2- Immunosuppressed states including diabetes mellitus, chronic renal failure, chronic liver failure and others.
  • 3- Underlying disease(e.g. lupus erythematous, IgA nephropathy, amyloidosis
  • 4- Evidence of steroid toxicity; Cataract , glaucoma, body mass index more than 30 or height less than or equal to -3SD

研究者

发起方
Post Graduate Institute of Medical Education and Research

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