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The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis
The role of itraconazole is still not clear in the treatment of chronic cavitary pulmonary aspergillosis(CCPA). Some studies have shown a beneficial role of itraconazole in reducing hemoptysis. So the present study is aimed at analyzing the role of itraconazole in CCPA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Itraconazole | Active Comparator | Role of itraconazole in CCPA |
|
| treatment in cavitary pulmonary aspergillosis | Experimental | Patients in this arm are given conservative management with antitussives, brochial artery embolisation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | Tablet 200 mg twice daily for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| clinical improvement in cough and hemoptysis | Clinical response- assessed by a decrease in frequency & intensity of hemoptysis & cough. Significant clinical response will be considered if there is no recurrence of episodes of moderate-massive hemoptysis. Number of interventions required to control hemoptysis will also be taken as a measure of clinical response | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological response of CCPA to itraconazole |
|
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Inclusion Criteria:
Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks.
Radiological findings:
Microbiological/Immunological findings: Positive results in the aspergillus precipitin test, demonstration of aspergillus hyphae in sputum or BAL fluid or cultures of BAL/sputum growing aspergillus species.
The diagnosis of CCPA will be made if
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vishwananath gella, DM | Post Graduate Institute of Medical Education and Research, Chandigarh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PGIMER | Chandigarh | Punjab | 160012 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10770732 | Background | Stevens DA, Kan VL, Judson MA, Morrison VA, Dummer S, Denning DW, Bennett JE, Walsh TJ, Patterson TF, Pankey GA. Practice guidelines for diseases caused by Aspergillus. Infectious Diseases Society of America. Clin Infect Dis. 2000 Apr;30(4):696-709. doi: 10.1086/313756. Epub 2000 Apr 20. | |
| 23496375 | Derived |
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| ID | Term |
|---|---|
| D001228 | Aspergillosis |
| D008271 | Mycetoma |
| ID | Term |
|---|---|
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D009617 | Nocardia Infections |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| treatment in cavitary pulmonary aspergillosis | Drug | Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE) |
|
| 6 months |
| Agarwal R, Vishwanath G, Aggarwal AN, Garg M, Gupta D, Chakrabarti A. Itraconazole in chronic cavitary pulmonary aspergillosis: a randomised controlled trial and systematic review of literature. Mycoses. 2013 Sep;56(5):559-70. doi: 10.1111/myc.12075. Epub 2013 Mar 18. |
| D000193 |
| Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D017192 | Skin Diseases, Bacterial |
| D003881 | Dermatomycoses |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010879 |
| Piperazines |