search
Back to results

Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis (ITRACONASP)

Primary Purpose

Chronic Cavitary Pulmonary Aspergillosis

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Itraconazole
treatment in cavitary pulmonary aspergillosis
Sponsored by
Postgraduate Institute of Medical Education and Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Cavitary Pulmonary Aspergillosis focused on measuring Itraconazole, chronic cavitary pulmonary aspergillosis, Aspergillosis, fungal ball, mycetoma, efficacy, safety

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

  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

Sites / Locations

  • PGIMER

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Itraconazole

treatment in cavitary pulmonary aspergillosis

Arm Description

Role of itraconazole in CCPA

Patients in this arm are given conservative management with antitussives, brochial artery embolisation.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 6, 2010
Last Updated
February 18, 2012
Sponsor
Postgraduate Institute of Medical Education and Research
search

1. Study Identification

Unique Protocol Identification Number
NCT01259336
Brief Title
Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis
Acronym
ITRACONASP
Official Title
A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Cavitary Pulmonary Aspergillosis
Keywords
Itraconazole, chronic cavitary pulmonary aspergillosis, Aspergillosis, fungal ball, mycetoma, efficacy, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Itraconazole
Arm Type
Active Comparator
Arm Description
Role of itraconazole in CCPA
Arm Title
treatment in cavitary pulmonary aspergillosis
Arm Type
Experimental
Arm Description
Patients in this arm are given conservative management with antitussives, brochial artery embolisation.
Intervention Type
Drug
Intervention Name(s)
Itraconazole
Other Intervention Name(s)
Study group
Intervention Description
Tablet 200 mg twice daily for 6 months
Intervention Type
Drug
Intervention Name(s)
treatment in cavitary pulmonary aspergillosis
Intervention Description
Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)
Primary Outcome Measure Information:
Title
clinical improvement in cough and hemoptysis
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Radiological response of CCPA to itraconazole
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical symptoms: -presence of chronic pulmonary/systemic symptoms lasting ≥ six weeks. 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. 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 Patient satisfies at least 1, 2a or 2b and/ or any of the 3rd criteria. FNAC from the cavity wall will be considered in atypical cases Exclusion Criteria: Invasive aspergillosis Allergic broncho-pulmonary aspergillosis (ABPA) Active tuberculosis or malignancy Pregnant females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vishwananath gella, DM
Organizational Affiliation
Post Graduate Institute of Medical Education and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIMER
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160012
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
10770732
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.
Results Reference
background
PubMed Identifier
23496375
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.
Results Reference
derived

Learn more about this trial

Efficacy Of Itraconazole In Chronic Cavitary Pulmonary Aspergillosis

We'll reach out to this number within 24 hrs