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| ID | Type | Description | Link |
|---|---|---|---|
| ITRFUN4025 | |||
| SPOIV-CHN-MA-04 |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole Sequential Therapy | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | Itraconazole 200 milligram (mg) intravenous injection will be given twice daily 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 for 2 to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Efficacy | 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. | Week 6 |
| Number of Participants With Mycological Efficacy | 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. | Week 6 |
| Number of Participants With Comprehensive Efficacy | 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. | Week 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xian-Janssen Pharmaceutical Ltd., China Clinical trial | Xian-Janssen Pharmaceutical Ltd. | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Itraconazole Sequential Therapy | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Itraconazole Sequential Therapy | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Out of 71 total participants, baseline characteristic (age) was available for only 60 participants who were included in the full analysis set (FAS) population. | Median | Full Range | years |
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| Sex: Female, Male | Out of 71 total participants, baseline characteristic (gender) was available for only 60 participants who were included in the full analysis set (FAS) population. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinical Efficacy | 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. | 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. | Posted | Number | participants | Week 6 |
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| Primary | Number of Participants With Mycological Efficacy | 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. | 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. | Posted | Number | participants | Week 6 |
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| Primary | Number of Participants With Comprehensive Efficacy | 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. | 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. | Posted | Number | participants | Week 6 |
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From the signing of informed consent until end of the study (week 6).
Safety set (SS) population (N=61) included all participants who received at least 1 dose of study drug and had safety documents.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Itraconazole Sequential Therapy | 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. | 4 | 61 | 13 | 61 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Edema | General disorders | No coding system | Non-systematic Assessment |
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| Death | General disorders | No coding system | Non-systematic Assessment |
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| Fungal infection | Immune system disorders | No coding system | Non-systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | No coding system | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Granulocytopenia | Blood and lymphatic system disorders | No coding system | Non-systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | No coding system | Non-systematic Assessment |
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| Hyperbilirubinemia | Hepatobiliary disorders | No coding system | Non-systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | No coding system | Non-systematic Assessment |
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| GPT increased | Hepatobiliary disorders | No coding system | Non-systematic Assessment |
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| Urinary tract infection | Renal and urinary disorders | No coding system | Non-systematic Assessment |
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| Renal function abnormal | Renal and urinary disorders | No coding system | Non-systematic Assessment |
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| Dermatoses | Skin and subcutaneous tissue disorders | No coding system | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | No coding system | Non-systematic Assessment |
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| Night sweating | General disorders | No coding system | Non-systematic Assessment |
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| Fever | General disorders | No coding system | Non-systematic Assessment |
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| Abdominal pain | General disorders | No coding system | Non-systematic Assessment |
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| Septic shock | General disorders | No coding system | Non-systematic Assessment |
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| Headache | General disorders | No coding system | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | No coding system | Non-systematic Assessment |
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| Non-specific anorexia | Gastrointestinal disorders | No coding system | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | No coding system | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | No coding system | Non-systematic Assessment |
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| Palpitation | Cardiac disorders | No coding system | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | No coding system | Non-systematic Assessment |
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| Tremor | Nervous system disorders | No coding system | Non-systematic Assessment |
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| Hemoptysis | Respiratory, thoracic and mediastinal disorders | No coding system | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Respiratory Department | Department of Respiratory Medicine, SHANGHAI First People's Hospital Affiliated to SHANGHAI JiaoTong University | 86-21-63071428 | xzhou53@163.com |
| ID | Term |
|---|---|
| D008172 | Lung Diseases, Fungal |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
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| Title | Measurements |
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| Failed |
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