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

Summary

To assess the efficacy of administrating daily caspofungin aerosols versus placebo for seven days, in adjunction of conventional systemic antifungal therapy during curative treatment of Pneumocystis pneumonia, on the clinical outcome at the end of the nebulized therapy, in order to support a "GO / NO GO" decision towards a phase III trial of nebulized caspofungin in those patients.

Conditions

• Pneumocystis Pneumonia
• Pneumocystis Jirovecii Infection
• Pneumocystis 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).

Sponsors & Collaborators

• University Hospital, Angers

  collaborator OTHER_GOV

• Centre Hospitalier Universitaire de Besancon

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• University Hospital, Brest

  collaborator OTHER

• Centre Hospitalier Universitaire Dijon

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• University Hospital, Lille

  collaborator OTHER

• University Hospital, Limoges

  collaborator OTHER

• Hospices Civils de Lyon

  collaborator OTHER

• University Hospital, Montpellier

  collaborator OTHER

• Nantes University Hospital

  collaborator OTHER

• Centre Hospitalier Universitaire de Nice

  collaborator OTHER

• Hospital Avicenne

  collaborator OTHER

• Henri Mondor University Hospital

  collaborator OTHER

• Hopital Foch

  collaborator OTHER

• Hôpital Necker-Enfants Malades

  collaborator OTHER

• Pitié-Salpêtrière Hospital

  collaborator OTHER

• Poitiers University Hospital

  collaborator OTHER

• Reims University hospital

  collaborator OTHER

• Ohre Pharma

  collaborator UNKNOWN

• Aerogen

  collaborator INDUSTRY

• Wako Diagnostics

  collaborator INDUSTRY

• Cape Cod Incorporated

  collaborator INDUSTRY

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

  collaborator OTHER_GOV

• Tours university

  collaborator UNKNOWN

• Amiens University Hospital

  collaborator OTHER

• Rennes University Hospital

  collaborator OTHER

• University Hospital, Tours

  lead OTHER

Principal Investigators

• Guillaume DESOUBEAUX, Prof · University Hospital of TOURS

• Stephan EHRMANN, Prof · University Hospital of TOURS

• Adrien LEMAIGNEN, Dr · University Hospital of TOURS

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-30

Primary Completion

2026-06-30

Completion

2028-12-31

Countries

• France

Study Locations