Ended Therapeutic confirmatory (Phase III) patients with acute respiratory failure from undetermined etiology

EFRAIM II _ Empirical steroids and/or antifungals treatment of immunocompromised patients with acute respiratory failure of uknown origin: a multicenter double-blind randomized controlled trial

EU CTIS ID: 2024-514344-82-00

What this study is testing

To reduce the 90-day mortality in immunocompromised patients with ARF from undetermined etiology at day-3. The intervention would evaluate the impact of steroids ± isavuconazole for 14 days or until ICU discharge.

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1) Age >18 years and <90 years
2) a) immunosuppressive drug b)solid organ transplant; c) solid tumor; d) hematological malignancies; e) primary immune deficiency;
3) ICU admission for acute respiratory failure as defined by a) respiratory distress with tachypnea (respiratory rate>30/min); b) cyanosis; c) laboured breathing; d) Need for more than 6l of standard oxygen to maintain SpO2>95%, or for high flow oxygen, non-invasive or invasive mechanical ventilation
4) No established ARF etiology 24 hours after hospital admission
5) Patient admitted for at least 24 hours at hospital
6) Informed consent signed: - by the patient, - Or informed consent signed by a family members/trustworthy person if his condition does not allow him to express his consent by written as per L. 1111-6, -Or in a situation urgently and in the absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow him to consent.

You likely can't join if

1) Patient who improved enough to be discharged from the ICU before inclusion
2) Documented invasive fungal infection requiring antifungal therapy;
3) • Patient needing or receiving prophylactic or empirical antifungal treatment for clinical care
4) Patient receiving corticoid therapy
5) Palliative care with comfort measures only (Do Not Intubate (DNI) and Do Not Resuscitate (DNR) patients can be included
6) Pregnant or breastfeeding;

See the full eligibility criteria

Who can join

1) Age >18 years and <90 years
2) a) immunosuppressive drug b)solid organ transplant; c) solid tumor; d) hematological malignancies; e) primary immune deficiency;
3) ICU admission for acute respiratory failure as defined by a) respiratory distress with tachypnea (respiratory rate>30/min); b) cyanosis; c) laboured breathing; d) Need for more than 6l of standard oxygen to maintain SpO2>95%, or for high flow oxygen, non-invasive or invasive mechanical ventilation
4) No established ARF etiology 24 hours after hospital admission
5) Patient admitted for at least 24 hours at hospital
6) Informed consent signed: - by the patient, - Or informed consent signed by a family members/trustworthy person if his condition does not allow him to express his consent by written as per L. 1111-6, -Or in a situation urgently and in the absence of family members/trustworthy person, the patient can be enrolled. The consent to participate to the research will be requested as soon as the condition of the patient will allow him to consent.

What rules you out

1) Patient who improved enough to be discharged from the ICU before inclusion
2) Documented invasive fungal infection requiring antifungal therapy;
3) • Patient needing or receiving prophylactic or empirical antifungal treatment for clinical care
4) Patient receiving corticoid therapy
5) Palliative care with comfort measures only (Do Not Intubate (DNI) and Do Not Resuscitate (DNR) patients can be included
6) Pregnant or breastfeeding;
7) No social security coverage
) Known hypersensitivity to isavuconazole or to any of excipients of CRESEMBA® specialty
9) Treatment with ketoconazole, ritonavir, or any CYP3A4/5 inductor
15) Person subject of psychiatric care.
10) Short QT syndrome and/or patient with a family history of short QT syndrome
11) Liver insufficiency (any stage)
12) moribund patients
13) Participation in another interventional research on acute respiratory failure.
14) Person deprived of liberty.
16) Patient under enforced hospitalization.
17) Adults under legal protection or unable to give their consent
18) Isolated HIV

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.