Caspofungin Aerosols for Pneumocystis Pneumonia in Adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial compares nebulized caspofungin given for seven days alongside standard systemic antifungal therapy versus placebo in adults with Pneumocystis pneumonia. It aims to determine the immediate clinical outcome after the nebulized treatment period to inform whether a larger phase III trial should proceed. Pneumocystis jirovecii pneumonia is common in immunocompromised patients and can lead to severe respiratory impairment; current therapies have limitations and potential side effects. The study uses a randomized, placebo-controlled design to evaluate safety and preliminary efficacy of the aerosol delivery route for caspofungin in this setting. Eligible participants are adults with microbiologically confirmed disease requiring respiratory support and systemic anti-Pneumocystis therapy.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Orléans
  Orléans, France Recruiting
• CHRU Tours
  Tours, France Recruiting
• CHU Tours
  Tours, France Not yet recruiting

Study contacts

• Study coordinator: Guillaume DESOUBEAUX, Prof
• Email: guillaume.desoubeaux@univ-tours.fr
• Phone: +33(0)2 34 37 89 26

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low-dose trimethoprim-sulfamethoxazole treatment for Pneumocystis (PCP) pneumonia

  This trial will test whether a lower daily dose of TMP‑SMX works as well but causes fewer side effects than the standard dose in adults with Pneumocystis (PCP) pneumonia who are immunocompromised.

  Recruiting Phase 3 McGill University Health Centre/Research Institute of the McGill University Health Centre · Montreal, Quebec · NCT04851015

• FUNGAL-P: A score to spot fungal pneumonia early in adults with pneumonia

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• Using caspofungin to treat Pneumocystis pneumonia in people with HIV.

  This study is testing whether caspofungin can be a safer treatment for Pneumocystis pneumonia in people with HIV/AIDS compared to the usual medication.

  Recruiting Instituto Nacional de Enfermedades Respiratorias · Mexico City, Tlalpan · NCT06691321

• Using rezafungin to treat Pneumocystis pneumonia in adults with HIV

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• Preventive treatment for pneumonia in patients with autoimmune diseases

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  Recruiting Phase 4 Tongji Hospital · Wuhan, Hubei · NCT06499233

• Better testing for Pneumocystis in people with weakened immune systems

  This project will try a new qPCR test on non-invasive respiratory samples to see if it can detect Pneumocystis in immunocompromised adults compared with standard reference tests.

  Recruiting at 4 sites Assistance Publique - Hôpitaux de Paris · Paris and 3 other locations · NCT06890078

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.