Interventional Recruiting Phase 1/Phase 2
NCT06892951 on ClinicalTrials.gov
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Official title: Phase I/II Safety lead-in Randomized Blind Placebo-controlled Clinical Trial: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia in Adjunction of Conventional Systemic Antifungal Therapy
- Sponsor: Centre Hospitalier Universitaire de Tours
- Collaborators: University Hospital, Angers, Centre Hospitalier Universitaire de Besancon, University Hospital, Bordeaux, University Hospital, Brest, Centre Hospitalier Universitaire Dijon, University Hospital, Grenoble, University Hospital, Lille, University Hospital, Limoges, Hospices Civils de Lyon, University Hospital, Montpellier, Nantes University Hospital, Centre Hospitalier Universitaire de Nice, Hospital Avicenne, Henri Mondor University Hospital, Hopital Foch, Hôpital Necker-Enfants Malades, Pitié-Salpêtrière Hospital, Poitiers University Hospital, Reims University hospital, Ohre Pharma, Aerogen, Wako Diagnostics, Cape Cod Incorporated, Institut National de la Santé Et de la Recherche Médicale, France, Tours university, Amiens University Hospital, Rennes University Hospital
- Enrollment: 100 (Estimated)
- Study start: 2025-12-02 (Actual)
- Primary completion: 2026-12-01 (Estimated)
- Study completion: 2028-12-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- InterventionModelDescription: The protocol will be carried out in a sequential manner to first provide safety data and the optimal dosing regimen on inhaled caspofungin, prior to inclusion of all the other patients: 1. Part 1: open-label, one arm, non-randomized, three centres study including six patients with ascending scheme regarding the rhythm of administration over one week, depending on the tolerance and closely monitored in intensive care unit to ensure that caspofungin is well tolerated via the inhaled route and to provide data supporting the proposed dose for part 2 (PK modeling) 2. Part 2: comparative, two arms, add-on, multicenter, individually-randomized placebo-controlled trial
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- PrimaryPurpose: Treatment
Brief 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
Intervention / Treatment
- Drug: Caspofungin Acetate 50 MG
- Drug: Physiologic saline
Primary Outcome Measures
-
Part 1: safety of inhaled caspofungin
(D-7 (day-7))
* frequency of adverse events * severity of adverse events -
Part 2: proportion of patients alive and with a favorable clinical course* at the seventh day (day-7) after the first administration.
(D7 (day-7))
Composite outcome defined by at least one of the two following items persisting ≥24 hours in alive patients: * Relative reduction (de-escalation or withdrawal) of respiratory assistance due to clinical improvement (depending on the initial support): * extubation, or * weaning of non-invasive ventilatory support, or * weaning of nasal high-flow or low-flow oxygen therapy; (NB: all participating centers will implement uniform protocols for ventilatory assistance weaning) * Occurrence of a +50% increase in oxygenation (PaO2 / FiO2 ratio vs. the worst value observed after inclusion).
Countries
France
Locations and Investigators
-
CHU Orléans, Orléans, France (Recruiting)
- François BARBIER
-
CHU Tours, Tours, France (Not yet recruiting)
- Elodie MOUSSET, MSc
- Guillaume DESOUBEAUX, MD PhD
- Guillaume DESOUBEAUX, MD PhD (Principal Investigator)
- Stephan EHRMANN, MD PhD
- Adrien LEMAIGNEN, MD PhD
-
CHRU Tours, Tours, France (Recruiting)
- Stephan EHRMANN
Study Officials
- Guillaume DESOUBEAUX, Prof (Study Director) — University Hospital of TOURS
- Stephan EHRMANN, Prof (Study Director) — University Hospital of TOURS
- Adrien LEMAIGNEN, Dr (Study Director) — University Hospital of TOURS