PCR Based Detection of Azole Resistance in A. Fumigatus to Improve Patient Outcome.

NCT03121235 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2022-03-23

No results posted yet for this study

Summary

A standard treatment protocol for invasive aspergillosis (IA) will be implemented in several academic hematology centers in the Netherlands in which a diagnostic test demonstrating azole resistance by multiplex real-time polymerase chain reaction will guide the choice of appropriate antifungal treatment.

Objectives:

1. Improve the outcome of patients infected with azole resistant A. fumigatus by the early detection of Resistance Associated Mutations (RAMs) and with this the earlier initiation of the most appropriate therapy.
2. Monitor the prevalence of invasive aspergillosis due to strains carrying the TR34/L98H or the TR46/T289A/Y121F resistance associated mutations in the Netherlands.

Conditions

  • Aspergillosis, Invasive Pulmonary

Interventions

DIAGNOSTIC_TEST

PCR based detection of azole resistance in A. fumigatus

Diagnosis and treatment of IA will be based on the results of a standardized diagnosis and treatment protocol that includes the use of the AsperGenius® PCR.

Sponsors & Collaborators

Principal Investigators

  • Bart JA Rijnders, MD/PhD · Internal Medicine and Infectious Diseases

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-20
Primary Completion
2021-12-31
Completion
2022-03-20

Countries

  • Netherlands

Study Locations

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Entities

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 NCT03121235 on ClinicalTrials.gov