Azole-echinocandin combination therapy for invasive aspergillosis. A randomized pragmatic superiority trial (IA-DUET)

Phase 3

Recruiting

• Conditions: Aspergillus infection; invasive aspergillosis; 10017528

• Registration Number: NL-OMON52868
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 325

Inclusion Criteria

1. 18 years or older
2. Have started or will start voriconazole or isavuconazole (or posaconazole if
voriconazole or isavuconazole cannot be given as per treating physician*s
decision) as antifungal therapy on the baseline visit.
3. For all patients: presence of one of the EORTC/MSG host factors or being
admitted to the ICU with influenza
4 For non-ICU patients or ICU patients without influenza: Meet the EORTC/MSG
clinical criterion.
5 For non-ICU patients or ICU patients without influenza: Meet the mycological
criterion or fulfil inclusion criterion 7.
6. For ICU patients with influenza we consider an isolated positive sputum
culture for Aspergillus spp. insufficient as a mycological criterion.
Therefore, in these patients only one of the following mycological criteria are
acceptable; Serum galactomannan >=0.5, BAL galactomannan >=1.0 or Aspergillus
spp. cultured in BAL fluid.

Exclusion Criteria

1. Known history of allergy, hypersensitivity or serious reaction to triazole
or echinocandin antifungals;
2.Patients with chronic invasive aspergillosis or a chronic non-invasive
aspergillus infection (e.g. aspergilloma) defined as the clinical or
radiological sign of infection being present for >28 days.
3. Receipt of itraconazole, voriconazole, posaconazole as prophylaxis for at
least 7 days in the 14 days preceding the date of the first radiological signs
of the Aspergillus infection. Patients in which the most recent serum level of
the triazole given as prophylaxis was subtherapeutic can be included.
4. Receipt of echinocandin prophylaxis for >96 hours in the preceding 7 days
5 Receipt of systemic antifungal treatment with an echinocandin, a
triazole (except fluconazole) or amphotericin B for the current episode of
invasive aspergillosis for a duration of > 96 hours.
6.. For patients in the Netherlands only: Diagnostic testing to exclude
triazole resistance will not be possible (sputum cultures are negative and BAL
sampling will not be performed)
7. ICU patients only: Patients with a sequential organ failure assessment
(SOFA) score >11 at the time of screening for the study are excluded. If
randomization is done >24 hours after screening the calculation should be
repeated before the patient can be randomized (appendix 3)
8. ICU patients only: Patients in which weaning from the ventilator or ECMO
system is deemed unlikely due to irreversible lung damage
9. Patients with any condition which, in the opinion of the investigator, could
affect patient safety, preclude evaluation of response (e.g. because survival
beyond 6 weeks is unlikely due to the underlying disease status)
10. Patient previously included in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified