A Randomized Controlled Trial to Compare the Clinical Outcomes With Six Months of Therapy With Oral Itraconazole Versus Oral Voriconazole for Management of Treatment naïve Subjects With Chronic Pulmonary Aspergillosis

NCT04824417 | Completed Phase 3

• 1 other identifier: PGI/IEC/2019/002366
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 2

Brief Summary

The current initial therapy for CPA is with six months of oral itraconazole. However, the response with six months of therapy has a response rate of 65-70% and has a relapse rate after stopping treatment of up to 50%. Voriconazole is a third-generation azole and a theoretical advantage of lower MICs compared to itraconazole. Also, oral voriconazole has good availability (95%) in fasting state. This is likely to improve the response rate and reduce the chances of relapse of chronic pulmonary aspergillosis. There is no head to head comparison of oral itraconazole with oral voriconazole. In this study we intent to compare the clinical outcomes with six months of therapy with oral itraconazole versus oral voriconazole for management of treatment naïve subjects with chronic pulmonary aspergillosis

Conditions

Chronic Pulmonary Aspergillosis

Keywords

cpa; aspergillosis

Outcome Measures

Primary Outcomes (1)

• proportion of subjects with an overall favourable response at the end of oral itraconazole therapy

  six months

Secondary Outcomes (2)

• number of relapses at six-months after completion of therapy

  six months

• adverse events due to itraconazole or voriconazole

  six months

Study Arms (2)

Control

ACTIVE COMPARATOR

Oral itraconazole

Drug: Itraconazole 200 mg

Intervention

EXPERIMENTAL

Oral voriconazole

Drug: Voriconazole 200mg

Interventions

Itraconazole 200 mg DRUG

Control

Control

Voriconazole 200mg DRUG

Comparator

Intervention

Eligibility Criteria

• Age: 13 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (2)

Chest clinic

Chandigarh, 160012, India

Location

Respiratory ICU, Department of Pulmonary Medicine, PGIMER

Chandigarh, 160012, India

Location

Related Publications (1)

• Sehgal IS, Agarwal R, Dhooria S, Prasad KT, Muthu V, Aggarwal AN, Rudramurthy SM, Garg M, Chakrabarti A. Oral itraconazole versus oral voriconazole for treatment-naive patients with chronic pulmonary aspergillosis in India (VICTOR-CPA trial): a single-centre, open-label, randomised, controlled, superiority trial. Lancet Infect Dis. 2025 Oct 29:S1473-3099(25)00537-7. doi: 10.1016/S1473-3099(25)00537-7. Online ahead of print.

  PMID: 41175884 DERIVED

MeSH Terms

Conditions

Aphakia, congenital primary; Aspergillosis

Interventions

Itraconazole; Voriconazole

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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized trial

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 1, 2021
• Study Start: March 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

IN (2)