CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Tours
About this trial
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.
Eligibility criteria
Qualifiers
Male and female ≥18 years
Microbiological diagnosis of Pneumocystis pneumonia
Respiratory support (oxygen therapy or ventilatory assistance)
Systemic co-trimoxazole therapy or systemic second-line anti-Pneumocystis salvage therapy (switch to another anti-Pneumocystis drug is possible, but should be notified) (initiated within 48 hours or less before enrolment)
Disqualifiers
None
Trial design
Treatments tested in this trial
- Caspofungin Acetate 50 MG
- Physiologic saline
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
University Hospital, Tours
Lead sponsor
University Hospital, Angers
Collaborator
Centre Hospitalier Universitaire de Besancon
Collaborator
University Hospital, Bordeaux
Collaborator
University Hospital, Brest
Collaborator
Centre Hospitalier Universitaire Dijon
Collaborator
University Hospital, Grenoble
Collaborator
University Hospital, Lille
Collaborator
University Hospital, Limoges
Collaborator
Hospices Civils de Lyon
Collaborator
University Hospital, Montpellier
Collaborator
Nantes University Hospital
Collaborator
Centre Hospitalier Universitaire de Nice
Collaborator
Hospital Avicenne
Collaborator
Henri Mondor University Hospital
Collaborator
Hopital Foch
Collaborator
Hôpital Necker-Enfants Malades
Collaborator
Pitié-Salpêtrière Hospital
Collaborator
Poitiers University Hospital
Collaborator
Reims University hospital
Collaborator
Ohre Pharma
Collaborator
Aerogen
Collaborator
Wako Diagnostics
Collaborator
Cape Cod Incorporated
Collaborator
Institut National de la Santé Et de la Recherche Médicale, France
Collaborator
Tours university
Collaborator
Amiens University Hospital
Collaborator
Rennes University Hospital
Collaborator
Source ClinicalTrials.gov