100
Participants
Start Date
June 30, 2025
Primary Completion Date
June 30, 2026
Study Completion Date
December 31, 2028
Caspofungin Acetate 50 MG
The experimental treatment will be administered once daily for up to seven days, through the nebulization route by the means of a disposable vibrating mesh Aeroneb solo® nebulizer with the valved mask (Galway, Ireland). Before generating aerosol, resuspension of the caspofungin powder will be carried out in the same manner than for the IV route, into 10.5 mL saline serum. Preparation of the experimental drug (re-suspension) will be unblindly carried out in a distinct medical office by a nurse neither involved in the healthcare of the included patients, nor in the other parts of the study, data recording or outcome assessment. Once reconstituted, the suspension is expected to be limpid, with neither odour nor foam. Thereafter, its administration will be blindly completed by the clinical staff in charge of the enrolled patient.
Physiologic saline
Procedures will be exactly the same than those described above for the experimental group, but caspofungin will be replaced during the seven days of intervention by 10mL of 0.9% saline nebulized in the control group for a 15 minute-long process of nebulization (from d-1 to d-7).
CHU Tours, Tours
Collaborators (3)
University Hospital, Angers
OTHER_GOV
Centre Hospitalier Universitaire de Besancon
OTHER
University Hospital, Bordeaux
OTHER
University Hospital, Brest
OTHER
Centre Hospitalier Universitaire Dijon
OTHER
University Hospital, Grenoble
OTHER
University Hospital, Lille
OTHER
University Hospital, Limoges
OTHER
Hospices Civils de Lyon
OTHER
University Hospital, Montpellier
OTHER
Nantes University Hospital
OTHER
Centre Hospitalier Universitaire de Nice
OTHER
Hospital Avicenne
OTHER
Henri Mondor University Hospital
OTHER
Hopital Foch
OTHER
Hôpital Necker-Enfants Malades
OTHER
Pitié-Salpêtrière Hospital
OTHER
Poitiers University Hospital
OTHER
Reims University hospital
OTHER
Ohre Pharma
UNKNOWN
Aerogen
INDUSTRY
Wako Diagnostics
INDUSTRY
Cape Cod Incorporated
INDUSTRY
Institut National de la Santé Et de la Recherche Médicale, France
OTHER_GOV
Tours university
UNKNOWN
Amiens University Hospital
OTHER
Rennes University Hospital
OTHER
University Hospital, Tours
OTHER