CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis … (NCT06892951) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
France100 participantsStarted 2025-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Absolut…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing inhaled caspofungin for Pneumocystis pneumonia — normally caspofungin is given intravenously, so is there any early safety data I should know about before considering an inhaled version?
2Since the trial is Phase 1/2 and hasn't started recruiting yet, what does that mean for how much is currently known about whether this approach works, and would standard treatment like TMP-SMX still be a safer first option for me?
3The trial measures whether patients are alive and doing well by day 7 after the first dose — given how serious PCP can be, is waiting to potentially join a trial a risk compared to starting proven treatment right away?
4Because this study hasn't begun recruiting yet, how long might it realistically be before I could even participate, and does that timeline affect my treatment decisions today?
5Would I need to be hospitalized or make frequent clinic visits to take part in a trial involving inhaled medication and close safety monitoring in the early phase, and is that something that would realistically fit my current situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: safety of inhaled caspofungin
Timeframe: D-7 (day-7)
2
Part 2: proportion of patients alive and with a favorable clinical course* at the seventh day (day-7) after the first administration.