Status:
UNKNOWN
Empirical Steroids and/or Antifungals in Immunocompromised Patients With Acute Respiratory Failure From Undetermined Etiology: a Multicenter Double-blind Randomized Controlled Trial
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Acute Respiratory Failure
Immunocompromised Patients
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Acute respiratory failure (ARF) is the leading reason of ICU admission in immunocompromised patients. Failure to identify the ARF etiology is associated with increased mechanical ventilation and morta...
Eligibility Criteria
Inclusion
- Age \>18 years and \< 90 years
- Known immunosuppression:
- immunosuppressive drug
- solid organ transplant
- solid tumor
- hematological malignancies
- primary immune deficiency
- ICU admission for acute respiratory failure as defined by
- respiratory distress with tachypnea (respiratory rate\>30/min)
- cyanosis
- laboured breathing
- need for more than 6L of standard oxygen to maintain SpO2\>95%, or for high flow oxygen, non-invasive or invasive mechanical ventilation
- No established ARF etiology at day 3
- 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 in written as per L1111-6,
- Or in an emergency situation 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).
- Note: Patient with Pneumocystis pneumonia can be included given that their treatment does not require the use of neither antifungal drugs nor corticosteroids
Exclusion
- Patient who improved enough to be discharged from the ICU at day 3
- Documented invasive fungal infection that requires antifungal therapy.
- Patient needing or receiving prophylactic or empirical antifungal treatment for clinical care
- Patient needing or receiving corticoid therapy
- Patient receiving palliative care with comfort measures only (Do Not Intubate (DNI) and Do Not Resuscitate (DNR) patients can be included)
- Pregnant or breastfeeding patient
- No social security coverage
- Known hypersensitivity to isavuconazole or to any of excipients of CRESEMBA® specialty
- Patient treated by ketoconazole, ritonavir, or any CYP3A4/5 inductor
- Short QT syndrome and/or patient with a family history of short QT syndrome;
- Liver insufficiency (any stage)
- Moribund patients
- Participation in another interventional research
Key Trial Info
Start Date :
December 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2023
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04680884
Start Date
December 21 2020
End Date
December 21 2023
Last Update
December 23 2020
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