Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT06892951
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06892951
Study Brief:
Protocol Section:
NCT06892951