CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2028

Conditions
Pneumocystis PneumoniaPneumocystis Jirovecii InfectionPneumocystis Infections
Interventions
DRUG

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.

DRUG

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).

Trial Locations (1)

37000

CHU Tours, Tours

Sponsors
All Listed Sponsors
collaborator

University Hospital, Angers

OTHER_GOV

collaborator

Centre Hospitalier Universitaire de Besancon

OTHER

collaborator

University Hospital, Bordeaux

OTHER

collaborator

University Hospital, Brest

OTHER

collaborator

Centre Hospitalier Universitaire Dijon

OTHER

collaborator

University Hospital, Grenoble

OTHER

collaborator

University Hospital, Lille

OTHER

collaborator

University Hospital, Limoges

OTHER

collaborator

Hospices Civils de Lyon

OTHER

collaborator

University Hospital, Montpellier

OTHER

collaborator

Nantes University Hospital

OTHER

collaborator

Centre Hospitalier Universitaire de Nice

OTHER

collaborator

Hospital Avicenne

OTHER

collaborator

Henri Mondor University Hospital

OTHER

collaborator

Hopital Foch

OTHER

collaborator

Hôpital Necker-Enfants Malades

OTHER

collaborator

Pitié-Salpêtrière Hospital

OTHER

collaborator

Poitiers University Hospital

OTHER

collaborator

Reims University hospital

OTHER

collaborator

Ohre Pharma

UNKNOWN

collaborator

Aerogen

INDUSTRY

collaborator

Wako Diagnostics

INDUSTRY

collaborator

Cape Cod Incorporated

INDUSTRY

collaborator

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

collaborator

Tours university

UNKNOWN

collaborator

Amiens University Hospital

OTHER

collaborator

Rennes University Hospital

OTHER

lead

University Hospital, Tours

OTHER

NCT06892951 - CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia | Biotech Hunter | Biotech Hunter