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

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ClinicalTrials.gov Identifier: NCT01823289
Recruitment Status : Completed
First Posted : April 4, 2013
Results First Posted : May 31, 2013
Last Update Posted : May 31, 2013
Sponsor:
Information provided by (Responsible Party):
Xian-Janssen Pharmaceutical Ltd.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pulmonary Fungal Infection
Intervention Drug: Itraconazole
Enrollment 71
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Itraconazole Sequential Therapy
Hide Arm/Group Description Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Period Title: Overall Study
Started 71
Completed 47
Not Completed 24
Reason Not Completed
Lost to Follow-up             5
Adverse Event             5
Lack of Efficacy             1
Physician Decision             9
Administered contraindicated medicine             1
Transaminase increased more than 3 times             1
Drug affected efficacy and safety             1
Creatinine clearance<30milliliter/minute             1
Arm/Group Title Itraconazole Sequential Therapy
Hide Arm/Group Description Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
55.5
(33.34 to 79.45)
[1]
Measure Description: Out of 71 total participants, baseline characteristic (age) was available for only 60 participants who were included in the full analysis set (FAS) population.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
23
  38.3%
Male
37
  61.7%
[1]
Measure Description: Out of 71 total participants, baseline characteristic (gender) was available for only 60 participants who were included in the full analysis set (FAS) population.
1.Primary Outcome
Title Number of Participants With Clinical Efficacy
Hide Description 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.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.
Arm/Group Title Itraconazole Sequential Therapy
Hide Arm/Group Description:
Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Cured 8
Markedly Improved 29
Improved 18
Failed 5
2.Primary Outcome
Title Number of Participants With Mycological Efficacy
Hide Description 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.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit. Here 'N' signifies those participants who were evaluable for this measure.
Arm/Group Title Itraconazole Sequential Therapy
Hide Arm/Group Description:
Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Overall Number of Participants Analyzed 30
Measure Type: Number
Unit of Measure: participants
Fungi cleared 20
Fungi not cleared 10
3.Primary Outcome
Title Number of Participants With Comprehensive Efficacy
Hide Description 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.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The Full analysis set (FAS) population included all participants who received at least 1 intravenous infusion or oral solution of the study drug and completed at least 1 post-baseline visit.
Arm/Group Title Itraconazole Sequential Therapy
Hide Arm/Group Description:
Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
Cured 8
Markedly Improved 32
Improved 16
Failed 4
Time Frame From the signing of informed consent until end of the study (week 6).
Adverse Event Reporting Description Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
 
Arm/Group Title Itraconazole Sequential Therapy
Hide Arm/Group Description Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
All-Cause Mortality
Itraconazole Sequential Therapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Itraconazole Sequential Therapy
Affected / at Risk (%)
Total   4/61 (6.56%) 
General disorders   
Edema * 1  1/61 (1.64%) 
Death * 1  2/61 (3.28%) 
Immune system disorders   
Fungal infection * 1  1/61 (1.64%) 
Respiratory, thoracic and mediastinal disorders   
Hemoptysis * 1  1/61 (1.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, No coding system
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Itraconazole Sequential Therapy
Affected / at Risk (%)
Total   13/61 (21.31%) 
Blood and lymphatic system disorders   
Granulocytopenia * 1  1/61 (1.64%) 
Cardiac disorders   
Palpitation * 1  1/61 (1.64%) 
Gastrointestinal disorders   
Nausea * 1  2/61 (3.28%) 
Non-specific anorexia * 1  1/61 (1.64%) 
Diarrhea * 1  2/61 (3.28%) 
Vomiting * 1  1/61 (1.64%) 
General disorders   
Night sweating * 1  1/61 (1.64%) 
Fever * 1  1/61 (1.64%) 
Abdominal pain * 1  1/61 (1.64%) 
Septic shock * 1  1/61 (1.64%) 
Headache * 1  1/61 (1.64%) 
Hepatobiliary disorders   
Hyperbilirubinemia * 1  1/61 (1.64%) 
Hepatic function abnormal * 1  3/61 (4.92%) 
GPT increased * 1  1/61 (1.64%) 
Metabolism and nutrition disorders   
Hypokalaemia * 1  3/61 (4.92%) 
Nervous system disorders   
Dizziness * 1  1/61 (1.64%) 
Tremor * 1  1/61 (1.64%) 
Renal and urinary disorders   
Urinary tract infection * 1  1/61 (1.64%) 
Renal function abnormal * 1  1/61 (1.64%) 
Respiratory, thoracic and mediastinal disorders   
Hemoptysis * 1  1/61 (1.64%) 
Skin and subcutaneous tissue disorders   
Dermatoses * 1  1/61 (1.64%) 
Rash * 1  1/61 (1.64%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, No coding system
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Director of Respiratory Department
Organization: Department of Respiratory Medicine, SHANGHAI First People’s Hospital Affiliated to SHANGHAI JiaoTong University
Phone: 86-21-63071428
EMail: xzhou53@163.com
Layout table for additonal information
Responsible Party: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov Identifier: NCT01823289     History of Changes
Other Study ID Numbers: CR014362
ITRFUN4025
SPOIV-CHN-MA-04
First Submitted: March 12, 2013
First Posted: April 4, 2013
Results First Submitted: April 12, 2013
Results First Posted: May 31, 2013
Last Update Posted: May 31, 2013