Clinical trial • Phase II • Infectious Disease
Caspofungin for Pneumocystis jirovecii pneumonia
Phase II trial of Caspofungin for Pneumocystis jirovecii pneumonia. Randomised, placebo (aerosol); dose and schedule not specified-controlled.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Pneumocystis jirovecii pneumonia
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 23-10-2024
- First CTIS Authorization Date
- 25-02-2025
Trial design
Randomised, placebo (aerosol); dose and schedule not specified-controlled Phase II trial across 3 sites in France.
- Randomised
- Yes
- Comparator
- Placebo (aerosol); dose and schedule not specified
- Target Sample Size
- 96
Eligibility
Recruits 96 Vulnerable population selected; no details on consent or assent handling provided..
- Vulnerable Population
- Vulnerable population selected; no details on consent or assent handling provided.
Recruitment
- Planned Sample Size
- 96
- Recruitment Window Months
- 39
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 96
France
- Earliest CTIS Part Ii Submission Date
- 15-01-2025
- Latest Decision Or Authorization Date
- 25-02-2025
- Processing Time Days
- 41
- Number Of Sites
- 3
- Number Of Participants
- 96
Sites
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Intensive care
- Contact Person Name
- Stephan EHRMANN
- Contact Person Email
- stephan.ehrmann@univ-tours.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Infectious diseases
- Contact Person Name
- Adrien LEMAIGNEN
- Contact Person Email
- a.lemaignen@univ-tours.fr
- Site Name
- Centre Hospitalier Regional D'Orleans
- Department Name
- Intensive care
- Contact Person Name
- François BARBIER
- Contact Person Email
- francois.barbier@chr-orleans.fr
Sponsor
Primary sponsor
- Full Name
- Centre Hospitalier Regional Universitaire De Tours
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- France
Investigational products
- Investigational Product Name
- Caspofungin (aerosol)
- Active Substance
- Caspofungin
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Aerosol / inhalation
- Route
- Aerosol / inhalation
- Combination Treatment
- Yes
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