CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia

Launched by UNIVERSITY HOSPITAL, TOURS · Mar 17, 2025

Keywords

ClinConnect Summary

The CaspoNEB trial is studying a new way to treat Pneumocystis pneumonia, a serious lung infection caused by a specific fungus. Researchers want to see if using an aerosol form of a medication called caspofungin, delivered through a nebulizer (a device that turns liquid medicine into a mist), is effective when given daily for seven days alongside standard antifungal treatments. This trial aims to determine if this method improves patient outcomes, and if successful, could lead to larger studies in the future.

To participate in this trial, individuals must be at least 18 years old and have a microbiological diagnosis of Pneumocystis pneumonia. They should also be receiving oxygen therapy or ventilatory assistance and have started antifungal treatment within the last 48 hours. Participants will need to provide written consent, either themselves or through a trusted family member if they are unable to do so. It's important to note that certain individuals, such as pregnant women or those with severe liver issues, cannot participate. If you join the trial, you can expect to receive treatment and follow-up care while helping researchers understand a potentially new approach to fighting this infection.

Gender

ALL

Eligibility criteria

• 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