A1501095 - Invasive Aspergillosis Study Version 1.0 11March2011

• Research type

  Research Study

• Full title

  A PROSPECTIVE, RANDOMIZED TRIAL COMPARING THE SAFETY, TOLERABILITY, AND EFFICACY OF VORICONAZOLE AND ANIDULAFUNGIN IN COMBINATION TO THAT OF VORICONAZOLE ALONE WHEN USED FOR PRIMARY THERAPY OF INVASIVE ASPERGILLOSIS IN PEDIATRIC SUBJECTS AGED 2 TO 17 YEARS

• IRAS ID

  65345

• Contact name

  Ajay Vora

• Sponsor organisation

  Pfizer Inc.

• Eudract number

  2010-021231-14

• Research summary

  Invasive Aspergillosis is an invasive infection caused by a fungus known as Aspergillus, which is commonly found in the environment and is usually inhaled into the lungs. Invasive infection means that an infection that started in the lungs has spread to other parts of the body through the bloodstream. This type of infection almost always occurs in people who have low immune system function due to a number of different reasons such as cancer (including leukemia), organ transplants, chemotherapy, use of steroid drugs, human immunodeficiency virus (HIV) infection and other diseases that reduce immune system function.The usual treatment for patients who have infections caused by a fungus is treatment with an antifungal medicine. The reason for carrying out this research is to find out how taking a combination of antifungal medicines (voriconazole and anidulafungin) to treat invasive Aspergillus infections compares to taking treatment with a single medicine, voriconazole.Voriconazole is a drug which is already available as a medicine for treating fungal infections in some countries. Anidulafungin is a drug which is already available as a medicine for treating other fungal infections in some countries; however, it is not approved to treat invasive Aspergillus infections. Given the high mortality of Invasive Aspergillosis and the need for better treatment strategies, the aim of this study is to extend experience with combination therapy in paediatric subjects and to gather data on its safety and efficacy.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  11/AL/0158

• Date of REC Opinion

  19 May 2011

• REC opinion

  Further Information Favourable Opinion