CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 320 enrolled
Drug / intervention
PCR based detection of azole resistance in A. fumigatusother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03121235
NCT03121235N/ACompleted
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PCR Based Detection of Azole Resistance in A. Fumigatus to Improve Patient Outcome. A Prospective Multicenter Observational Study.

Erasmus Medical Center·observational·Posted Apr 20, 2017·Updated Mar 23, 2022

In Brief

An observational study evaluating PCR based detection of azole resistance in A. fumigatus for Aspergillosis, Invasive Pulmonary. Completed, enrolled 320 participants across 8 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAspergillosis, Invasive Pulmonary
CountriesNetherlands
CollaboratorsGilead Sciences

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 20, 2017
Enrollment StartApr 20, 2017
Primary CompletionDec 31, 2021
Study CompletionMar 20, 2022
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.2 years ago

Interventions

PCR based detection of azole resistance in A. fumigatusother

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.