NCT07825259

Brief Summary

A prospective, randomized, open-label comparative study evaluating oral itraconazole and oral posaconazole in treatment-naïve patients with CPA, with treatment for 12 months is proposed. The study will compare clinical effectiveness and safety of the study drugs. The findings will generate evidence to guide individualized antifungal therapy, inform antifungal stewardship strategies, and strengthen resistance surveillance frameworks for CPA. As the first randomized evaluation of posaconazole in CPA, the study has the potential to directly influence clinical practice and international treatment recommendations for this neglected fungal disease

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3

Timeline
39mo left

Started Nov 2026

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

3.1 years

First QC Date

September 11, 2026

Last Update Submit

September 28, 2026

Conditions

Chronic Pulmonary Aspergillosis

Keywords

AspergillosisTriazolesPosaconazoleItraconazoleAspergilloma

Outcome Measures

Primary Outcomes (1)

  • Overall favorable treatment response at 12 months

    Defined by: (1) Clinical improvement or stability; (2) Radiological improvement or stability on chest CT; and (3) No requirement for antifungal modification because of treatment failure.

    12 months

Secondary Outcomes (5)

  • Significant treatment-emergent adverse events

    12 months

  • CPA relapse

    18 months

  • Time to first CPA relapse

    18 months

  • Quality of life assessment by SGRQ

    12 months

  • All-cause and CPA-related mortality during follow-up

    18 months

Other Outcomes (11)

  • Subgroup analyses

    12 months

  • Overall favorable treatment response at 6 months

    6 months

  • Unfavourable treatment response or CPA relapse

    18 months

  • +8 more other outcomes

Study Arms (2)

Itraconazole

ACTIVE COMPARATOR

Itraconazole suprabioavailable capsule 130 mg twice daily

Drug: Itraconazole (ITZ)

Posaconazole

EXPERIMENTAL

Posaconazole 100 mg sustained release capsule (300 mg once a day)

Drug: Posaconazole Delayed Release Oral Tablet

Interventions

Posaconazole Delayed Release Oral TabletDRUG

Posaconazole 300 mg will be given once daily

Posaconazole
Itraconazole (ITZ)DRUG

Itraconazole suprabioavailable will be given 130 mg twice daily

Itraconazole

Eligibility Criteria

Age12 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • One or more clinical symptoms (persistent cough, recurrent haemoptysis, weight loss, malaise, fever, dyspnoea) for ≥3 months
  • Slowly progressive or persistent radiological findings on CT thorax including one or more cavities with or without a fungal ball, fibrosis, pericavitary infiltrates, consolidation, nodules, or pleural thickening
  • Serum A. fumigatus-IgG ≥27 milligrams of antibody/litre (mgA/L), or growth of Aspergillus in respiratory secretions (twice in sputum or once in bronchoalveolar lavage fluid \[BALF\]) or serum galactomannan index (GMI) ≥1.7 or BALF GMI ≥2.6.

You may not qualify if:

  • Failure or refusal to provide written informed consent
  • Patients on immunosuppressive drugs, receiving prednisolone (or equivalent) ≥10 mg/day for ≥3 weeks, or known HIV infection
  • Intake of antifungal triazoles for ≥3 weeks in the preceding 3 months (prior azole therapy)
  • Active pulmonary infection due to Mycobacterium tuberculosis or non-tuberculous mycobacteria
  • Other forms of pulmonary aspergillosis (subacute or acute invasive aspergillosis)
  • Pregnancy or lactation
  • Significant hepatic dysfunction (ALT/AST ≥3× upper limit of normal at baseline)
  • Known hypersensitivity to azole antifungals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chest Clinic, PGIMER, Chandigarh

Chandigarh, Chandigarh, 160012, India

Location

Chest Clinic, PGIMER, Chandigarh

Chandigarh, Chandigarh, 160012, India

Location

Related Publications (1)

  • REFERENCES Sehgal, I. S., Muthu, V., Salzer, H. J. F., & Agarwal, R. (2026). Post-tuberculosis lung disease and pulmonary aspergillosis management: challenges and considerations. Expert Rev Anti Infect Ther, 1-21. doi:10.1080/14787210.2026.2631525 Sehgal, I. S., Soundappan, K., Agarwal, R., Muthu, V., Dhooria, S., Prasad, K. T., . . . Chakrabarti, A. (2025). Prevalence of Chronic Pulmonary Aspergillosis in Patients With Mycobacterial and Non-Mycobacterial Tuberculosis Infection of the Lung: A Systematic Review and Meta-Analysis. Mycoses, 68(4), e70060. doi:10.1111/myc.70060 Sehgal, I. S., Agarwal, R., Dhooria, S., Prasad, K. T., Muthu, V., Aggarwal, A. N., . . . Chakrabarti, A. (2026). 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, 26(3), 239-249. doi:10.1016/S1473-3099(25)00537-7 Sehgal, I. S., Dhooria, S., Muthu, V., Salzer, H. J. F., & Agarwal, R. (2024). Burden, clinical features, and outcomes of post-tuberculosis chronic obstructive lung diseases. Curr Opin Pulm Med, 30(2), 156-166. doi:10.1097/MCP.0000000000001026 Sehgal, I. S., Dhooria, S., Muthu, V., Prasad, K. T., Aggarwal, A. N., Chakrabarti, A., . . . Agarwal, R. (2022). 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, 22(7), 1052-1061. doi:10.1016/S1473-3099(22)00057-3 Ashbee, H. R., Barnes, R. A., Johnson, E. M., Richardson, M. D., Gorton, R., & Hope, W. W. (2014). Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology. J Antimicrob Chemother, 69(5), 1162-1176. doi:10.1093/jac/dkt508 Soundappan, K., Sehgal, I. S., Prabhakar, N., Rana, S., Raju, R., Dhooria, S., . . . Agarwal, R. (2024). Incidence and prevalence of ch

    BACKGROUND

MeSH Terms

Conditions

Aspergillosis

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Central Study Contacts

Inderpaul S Sehgal, MD, DM

CONTACT

+91-172-2756823inderpgi@outlook.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor and the radiologist will be blinded to the treatment allocation
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 17, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

October 1, 2026

Record last verified: 2026-09

Locations

IN(2)