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Completed

NCT Number: NCT01259336

Efficacy 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

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Key information

Conditions

Chronic Cavitary Pulmonary Aspergillosis Actinomycetales Infections Aspergillosis Bacterial Infections Bacterial Infections and Mycoses Dermatomycoses Gram-Positive Bacterial Infections Infections Mycetoma Mycoses Nocardia Infections Skin Diseases Skin Diseases, Bacterial Skin Diseases, Infectious Skin and Connective Tissue Diseases

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

PGIMER

Chandigarh, Punjab, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Itraconazole

Drug

Tablet 200 mg twice daily for 6 months

Other names: Study group

treatment in cavitary pulmonary aspergillosis

Drug

Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)

Primary outcomes

  1. clinical improvement in cough and hemoptysis

    Time frame: 6 months

    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 outcomes

  1. Radiological response of CCPA to itraconazole

    Time frame: 6 months

    • 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

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

A RANDOMIZED CONTROLLED STUDY OF ITRACONAZOLE IN CHRONIC CAVITARY PULMONARY ASPERGILLOSIS

Acronym: ITRACONASP

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 14, 2010
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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