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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-08-14

No results posted yet for this study

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

Interventions

DRUG

Itraconazole 200 mg

Control

DRUG

Voriconazole 200mg

Comparator

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04824417 on ClinicalTrials.gov