Six Months Versus 12 Months of Oral Itraconazole Therapy for Management of Treatment naïve Subjects With CPA

NCT03920527 | Completed Phase 3 DMC

• 1 other identifier: NK/4947/Res/986
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

The treatment options majorly consist of medical management with at least 6-month long treatment with antifungal drugs - most significantly the azole groups. Itraconazole is the preferred azole for the treatment of CPA. The duration of treatment with oral itraconazole remains uncertain. In a previous study the use of oral itraconazole for 6-months a favorable overall response was seen in 76% of the subjects. Moreover, about 30%-50% of the subjects have disease relapse that requires prolonged therapy. It is likely that a longer duration of itraconazole would have a higher response rate and thus, lower risk of relapse after discontinuation of therapy. In this randomized controlled trial, we compare the clinical outcomes of six months versus twelve months of itraconazole therapy in treatment naïve subjects with chronic pulmonary aspergillosis

Conditions

Chronic Pulmonary Aspergillosis

Keywords

CPA; Aspergillosis; CCPA; CFPA

Outcome Measures

Primary Outcomes (1)

• Relapse rate

  number of relapses at 2 year after randomization

  2 year after randomization

Secondary Outcomes (2)

• Response

  at 6 to 12 months

• Adverse events

  1 year

Study Arms (2)

Six months

ACTIVE COMPARATOR

Six months of itraconazole

Drug: Itraconazole 400 mg

12 months

EXPERIMENTAL

12-months of itraconazole

Drug: Itraconazole 400 mg

Interventions

Itraconazole 400 mg DRUG

Duration of itraconazole

Also known as: sporanox

12 months; Six months

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• one or more clinical symptoms (persistent cough, recurrent hemoptysis, weight loss, malaise, fever and dyspnea) for ≥3 months
• slowly progressive or persistent radiological findings (one or more cavities and surrounding fibrosis, infiltrates, consolidation, with or without fungal ball or progressive pleural thickening) on computed tomography (CT) of the thorax
• immunological (A.fumigatus-specific IgG \>27 mgA/L or positive Aspergillus precipitins) or microbiological evidence of Aspergillus infection (growth of Aspergillus in respiratory secretions or serum galactomannan index \>0.5 or BALF galactomannan index \>1) and,

You may not qualify if:

• failure to provide informed consent
• patients on immunosuppressive drugs, intake of prednisolone (or equivalent) \>10 mg for at least 3 weeks or a diagnosis of human immunodeficiency virus syndrome
• intake antifungal azoles for \>3 weeks in the preceding six months
• subjects with active pulmonary infection due to mycobacterium tuberculosis or mycobacteria other than tuberculosis (MOTT)
• subjects with others forms of pulmonary aspergillosis (allergic bronchopulmonary aspergillosis, chronic necrotizing aspergillosis and angio-invasive aspergillosis)
• pregnancy

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Inderpaul Singh

Chandigarh, 160012, India

Location

Related Publications (1)

• Sehgal IS, Dhooria S, Muthu V, Prasad KT, Aggarwal AN, Chakrabarti A, Choudhary H, Garg M, Agarwal R. Efficacy of 12-months oral itraconazole versus 6-months oral itraconazole to prevent relapses of chronic pulmonary aspergillosis: an open-label, randomised controlled trial in India. Lancet Infect Dis. 2022 Jul;22(7):1052-1061. doi: 10.1016/S1473-3099(22)00057-3. Epub 2022 Apr 13.

  PMID: 35429465 DERIVED

MeSH Terms

Conditions

Aspergillosis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 19, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: August 15, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)