Chronic Cavitary Pulmonary Aspergillosis Clinical Trial
— ITRACONASPOfficial title:
A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS
The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis
| Status | Completed |
| Enrollment | 31 |
| Est. completion date | December 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 14 Years to 80 Years |
| Eligibility |
1. Inclusion Criteria: 1. Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting = six weeks. 2. Radiological findings: - Evidence of slowly progressive pulmonary lesions over weeks-months including cavities with surrounding inflammation. - presence of intracavitary mass with a surrounding crescent of air,and presence of pleural thickening in peripheral lesions. 3. 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. 2. The diagnosis of CCPA will be made if 1. Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria. 2. FNAC from the cavity wall will be considered in atypical cases 3. Exclusion Criteria: 1. Invasive aspergillosis 2. Allergic broncho-pulmonary aspergillosis (ABPA) 3. Active tuberculosis or malignancy 4. Pregnant females |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | PGIMER | Chandigarh | Punjab |
| Lead Sponsor | Collaborator |
|---|---|
| Postgraduate Institute of Medical Education and Research |
India,
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. Epub 2000 Apr 20. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Radiological response of CCPA to itraconazole | Complete response- It is defined as complete disappearance of the aspergilloma. Partial response- It is defined as 30% decrease in the sum of the longest diameters of all the lesions. Progressive disease- It is defined as appearance of any new lesions or >20% increase in the sum of the longest diameters of all measurable lesions. Stable disease- Shrinkage or growth of CCPA that does not meet any of these criteria |
6 months | No |