Caspofungin Acetate 50 MG: The experimental treatment will be administered once daily for up to seven days, through the nebulization route by the means of a disposable vibrating mesh Aeroneb solo® nebulizer with the valved mask (Galway, Ireland). Before generating aerosol, resuspension of the caspofungin powder will be carried out in the same manner than for the IV route, into 10.5 mL saline serum. Preparation of the experimental drug (re-suspension) will be unblindly carried out in a distinct medical office by a nurse neither involved in the healthcare of the included patients, nor in the other parts of the study, data recording or outcome assessment. Once reconstituted, the suspension is expected to be limpid, with neither odour nor foam. Thereafter, its administration will be blindly completed by the clinical staff in charge of the enrolled patient.
Physiologic saline: Procedures will be exactly the same than those described above for the experimental group, but caspofungin will be replaced during the seven days of intervention by 10mL of 0.9% saline nebulized in the control group for a 15 minute-long process of nebulization (from d-1 to d-7).
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Part 1: safety of inhaled caspofungin — D-7 (day-7) * frequency of adverse events
* severity of adverse events
Part 2: proportion of patients alive and with a favorable clinical course* at the seventh day (day-7) after the first administration. — D7 (day-7) Composite outcome defined by at least one of the two following items persisting ≥24 hours in alive patients:
* Relative reduction (de-escalation or withdrawal) of respiratory assistance due to clinical improvement (depending on the initial support):
* extubation, or
* weaning of non-invasive ventilatory support, or
* weaning of nasal high-flow or low-flow oxygen therapy; (NB: all participating centers will implement uniform protocols for ventilatory assistance weaning)
* Occurrence of a +50% increase in oxygenation (PaO2 / FiO2 ratio vs. the worst value observed after inclusion).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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