A Phase 4 interventional study of Itraconazole in Pulmonary Fungal Infection, sponsored by Xian-Janssen Pharmaceutical Ltd.. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-05-31.
Sponsored by Xian-Janssen Pharmaceutical Ltd. · Phase 4, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 71 is below the median of 120 across 4,200 interventional studies indexed under Infections.
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Exclusion Criteria:
Drug: Itraconazole
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Week 6
| Milestone | Itraconazole Sequential Therapy |
|---|---|
| Started | 71 |
| Completed | 47 |
| Not completed | 24 |
| Withdrew: Lost to follow-up | 5 |
| Withdrew: Adverse event | 5 |
| Withdrew: Lack of efficacy | 1 |
| Withdrew: Physician decision | 9 |
| Withdrew: Administered contraindicated medicine | 1 |
| Withdrew: Transaminase increased more than 3 times | 1 |
| Withdrew: Drug affected efficacy and safety | 1 |
| Withdrew: Creatinine clearance<30milliliter/minute | 1 |
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.
| participants | Itraconazole Sequential Therapy |
|---|---|
| Cured | 8 |
| Markedly Improved | 29 |
| Improved | 18 |
| Failed | 5 |
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.
| participants | Itraconazole Sequential Therapy |
|---|---|
| Fungi cleared | 20 |
| Fungi not cleared | 10 |
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.
| participants | Itraconazole Sequential Therapy |
|---|---|
| Cured | 8 |
| Markedly Improved | 32 |
| Improved | 16 |
| Failed | 4 |
Collected over From the signing of informed consent until end of the study (week 6).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Itraconazole Sequential Therapy | — | 4/61 (6.6%) | 13/61 (21.3%) |
| Event | Itraconazole Sequential Therapy |
|---|---|
| DeathGeneral disorders | 2/61 |
| EdemaGeneral disorders | 1/61 |
| Fungal infectionImmune system disorders | 1/61 |
| HemoptysisRespiratory, thoracic and mediastinal disorders | 1/61 |
| Event | Itraconazole Sequential Therapy |
|---|---|
| HypokalaemiaMetabolism and nutrition disorders | 3/61 |
| Hepatic function abnormalHepatobiliary disorders | 3/61 |
| NauseaGastrointestinal disorders | 2/61 |
| DiarrheaGastrointestinal disorders | 2/61 |
| GranulocytopeniaBlood and lymphatic system disorders | 1/61 |
| HyperbilirubinemiaHepatobiliary disorders | 1/61 |
| GPT increasedHepatobiliary disorders | 1/61 |
| Urinary tract infectionRenal and urinary disorders | 1/61 |
| Renal function abnormalRenal and urinary disorders | 1/61 |
| DermatosesSkin and subcutaneous tissue disorders | 1/61 |
| Age Continuous(years) | Itraconazole Sequential Therapy |
|---|---|
| Median | 55.5 (33.34 to 79.45) |
| Sex: Female, Male(Participants) | Itraconazole Sequential Therapy |
|---|---|
| Female | 23 |
| Male | 37 |
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Xian-Janssen Pharmaceutical Ltd.