Clinical trial NCT01259336: Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis
Official title: A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Cavitary Pulmonary Aspergillosis
Keywords: Itraconazole
chronic cavitary pulmonary aspergillosis
Aspergillosis
fungal ball
mycetoma
efficacy
safety
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2010-12-14
Enrollment: 31
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether there itraconazole is effective in the treatment of chronic cavitary pulmonary aspergillosis

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: clinical improvement in cough and hemoptysis
timeFrame: 6 months
Secondary outcomes:
measure: Radiological response of CCPA to itraconazole
timeFrame: 6 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: PGIMER
state: Punjab
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Vishwananath gella, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.