Clinical Trial: An Efficacy and Safety Study of Itraconazole Sequential Therapy (Intravenous Injection Followed by Oral Solution) in Invasive Pulmonary Fungal Infections

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Efficacy and Safety of Itraconazole Injection/Oral Solution Sequential Therapy for Treatment of Invasive Pulmonary Fungal Infections

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of itraconazole sequential therapy (intravenous injection/oral solution) in participants with invasive pulmonary fungal infections ([IPFI]; lung diseases caused by fungal infection).

Detailed Summary: This is an open-label (all people know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the efficacy and safety of itraconazole sequential therapy in participants with IPFI. The study duration will be 4 to 6 weeks. The treatment will be divided into the intravenous (into a vein) injection period and the oral solution administration (giving) period. During the intravenous injection period 200 milligram (mg) twice daily loading dose (large initial dose) will be given for first 2 days, 200 mg once daily for the subsequent 12 days. Then sequential itraconazole oral solution 200 mg twice daily will be given as maintenance therapy (treatment designed to help the original primary treatment to succeed) for 2-4 weeks. Participant's clinical, mycological and comprehensive efficacy will be assessed at Week 6. Participants' safety will be monitored throughout the study.
Sponsor: Xian-Janssen Pharmaceutical Ltd.

Current Primary Outcome:

  • Number of Participants With Clinical Efficacy [ Time Frame: Week 6 ]
    Clinical efficacy was assessed as cured: the signs and symptoms of invasive fungal infections (IFI) completely disappeared or full or nearby resolution of radiographic manifestations; markedly improved: the signs and symptoms of IFI were improved or disappeared and at least 50 percent improvement of radiographic findings; improved: the signs and symptoms of IFI were moderately improved and less than 50 percent improvement of radiographic findings; failed: the clinical symptoms and signs of IFI were not changed or worsened.
  • Number of Participants With Mycological Efficacy [ Time Frame: Week 6 ]
    Mycological efficacy was assessed as fungi cleared: negative for fungal microscopic examination and culture (test for infection or organisms that could cause infection); fungi not cleared: positive for fungal microscopic examinations and/or culture.
  • Number of Participants With Comprehensive Efficacy [ Time Frame: Week 6 ]
    Comprehensive efficacy was assessed as cured: the symptoms, signs, laboratory examination and pathogenic examination were return to normal; markedly improved: the disease condition was markedly improved but symptoms, signs, laboratory examination and pathogenic examination were not return to normal; improved: the disease condition was improved to some extent after drug administration, but the improvement was not significant enough; failed: the disease condition was not improved significantly or worsened after drug administration.


Original Primary Outcome:

  • Number of Participants with Clinical Efficacy at Week 6 [ Time Frame: Week 6 ]
    Clinical efficacy will be assessed as 1) Cured: The signs and symptoms of invasive fungal infections (IFI) completely disappear or full or nearby resolution of radiographic manifestations; 2) Markedly Improved: The signs and symptoms of IFI are improved or disappear and at least 50 percent improvement of radiographic findings; 3) Improved: The signs and symptoms of IFI are moderately improved and less than 50 percent improvement of radiographic findings; 4) Failed: The clinical symptoms and signs of IFI are not changed or worsened.
  • Number of Participants with Mycological Efficacy at Week 6 [ Time Frame: Week 6 ]
    Mycological efficacy will be assessed as 1) Fungi cleared: Negative for fungal microscopic examination and culture (test for infection or organisms that could cause infection); 2) Fungi not cleared: Positive for fungal microscopic examinations and/or culture.
  • Number of Participants with Comprehensive Efficacy at Week 6 [ Time Frame: Week 6 ]
    Comprehensive efficacy will be assessed as 1) Cured: The symptoms, signs, laboratory examination and pathogenic examination are return to normal; 2) Markedly Improved: The disease condition is markedly improved but symptoms, signs, laboratory examination and pathogenic examination are not return to normal; 3) Improved: The disease condition is improved to some extent after drug administration, but the improvement is not significant enough; 4) Failed: The disease condition is not improved significantly or worsened after drug administration.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Xian-Janssen Pharmaceutical Ltd.

Dates:
Date Received: March 12, 2013
Date Started: June 2007
Date Completion:
Last Updated: April 12, 2013
Last Verified: April 2013