Status:
NOT_YET_RECRUITING
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Lead Sponsor:
University Hospital, Tours
Collaborating Sponsors:
University Hospital, Angers
Centre Hospitalier Universitaire de Besancon
Conditions:
Pneumocystis Pneumonia
Pneumocystis Jirovecii Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 p...
Detailed Description
Pneumocystis jirovecii is an airborne-transmissible fungus which can induce pneumonia with severely impaired lung function, especially in immunocompromised patients. At least 1,000 new cases of Pneumo...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male and female ≥18 years
- Medical management of Pneumocystis pneumonia based on :
- 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)
- Person affiliated to a French social security system or equivalent
- Written informed consent obtained from the participant or, if the patient is not able to give consent from representative (trusted person, family member) or if the delay in obtaining the consent is assumed not compatible with the enrollment requirements, a temporary approval can be obtained from the investigator. In all cases, the patient's written informed consent will have to be obtained as soon as possible.
- Non-inclusion criteria:
- Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons: pregnant women, parturients, nursing mothers, persons deprived of their liberty by judicial or administrative decision, minors, and persons subject to a legal protection measure: guardianship or trusteeship). Pregnancy test to be performed in all women from 15 to 45 years old who have not had an ovariectomy.
- Other indication(s) for systemic administration of an echinocandin drug
- Known allergy to echinocandin drugs
- Absolute contraindication to aerosol therapy
- Concomitant co-infection at time of diagnosis (except HIV infection)
- Severe liver impairment (i.e. documented severe liver cirrhosis (Child C), or Factor-V protein \< 50% and/or INR for prothrombin time of blood coagulation \> 1.5)
- history of toxic epidermal necrosis (TEN) and Steven-Johnson syndrome (SJS)
- Participation in other pharmacological study that focuses on echinocandins and/or anti-infectious aerosol therapy or other anti-pneumocystis treatment
- Participation in a trial with an investigational product known to have pulmonary toxicity or of which the safety is not known
Exclusion
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06892951
Start Date
June 1 2025
End Date
December 1 2028
Last Update
March 25 2025
Active Locations (1)
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1
CHU Tours
Tours, France, 37000