drugset / Trial / NCT06892951
CaspoNEB: Efficacy and Safety of Caspofungin Aerosols for the Curative Treatment of Pneumocystis Pneumonia
Phase 1/2
Not yet recruiting
100 enrolled
University Hospital, Tours
Aerogen · collabAmiens University Hospital · collabCape Cod Incorporated · collabCentre Hospitalier Universitaire Dijon · collabCentre Hospitalier Universitaire de Besancon · collabCentre Hospitalier Universitaire de Nice · collabHenri Mondor University Hospital · collabHopital Foch · collabHospices Civils de Lyon · collabHospital Avicenne · collabHôpital Necker-Enfants Malades · collabInstitut National de la Santé Et de la Recherche Médicale, France · collabNantes University Hospital · collabOhre Pharma · collabPitié-Salpêtrière Hospital · collabPoitiers University Hospital · collabReims University hospital · collabRennes University Hospital · collabTours university · collabUniversity Hospital, Angers · collabUniversity Hospital, Bordeaux · collabUniversity Hospital, Brest · collabUniversity Hospital, Grenoble · collabUniversity Hospital, Lille · collabUniversity Hospital, Limoges · collabUniversity Hospital, Montpellier · collabWako Diagnostics · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2025-06
- Primary completion
- 2026-06
- Completion
- 2028-12
Publications
- Results Limper AH. Alveolar macrophage and glycoprotein responses to Pneumocystis carinii. Semin Respir Infect. 1998 Dec;13(4):339-47.
- Results McKinnell JA, Cannella AP, Kunz DF, Hook EW 3rd, Moser SA, Miller LG, Baddley JW, Pappas PG. Pneumocystis pneumonia in hospitalized patients: a detailed examination of symptoms, management, and outcomes in human immunodeficiency virus (HIV)-infected and HIV-uninfected persons. Transpl Infect Dis. 2012 Oct;14(5):510-8. doi: 10.1111/j.1399-3062.2012.00739.x. Epub 2012 May 1.
- Results Lobo ML, Esteves F, de Sousa B, Cardoso F, Cushion MT, Antunes F, Matos O. Therapeutic potential of caspofungin combined with trimethoprim-sulfamethoxazole for pneumocystis pneumonia: a pilot study in mice. PLoS One. 2013 Aug 5;8(8):e70619. doi: 10.1371/journal.pone.0070619. Print 2013.
- Results Wong-Beringer A, Lambros MP, Beringer PM, Johnson DL. Suitability of caspofungin for aerosol delivery: physicochemical profiling and nebulizer choice. Chest. 2005 Nov;128(5):3711-6. doi: 10.1378/chest.128.5.3711.
- Results Ehrmann S, Mercier E, Vecellio L, Ternant D, Paintaud G, Dequin PF. Pharmacokinetics of high-dose nebulized amikacin in mechanically ventilated healthy subjects. Intensive Care Med. 2008 Apr;34(4):755-62. doi: 10.1007/s00134-007-0935-1. Epub 2007 Nov 29.
- Results Beitler JR, Sarge T, Banner-Goodspeed VM, Gong MN, Cook D, Novack V, Loring SH, Talmor D; EPVent-2 Study Group. Effect of Titrating Positive End-Expiratory Pressure (PEEP) With an Esophageal Pressure-Guided Strategy vs an Empirical High PEEP-Fio2 Strategy on Death and Days Free From Mechanical Ventilation Among Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA. 2019 Mar 5;321(9):846-857. doi: 10.1001/jama.2019.0555.
- Results Desoubeaux G, Lemaignen A, Ehrmann S. Scientific rationale for inhaled caspofungin to treat Pneumocystis pneumonia: A therapeutic innovation likely relevant to investigate in a near future.... Int J Infect Dis. 2020 Jun;95:464-467. doi: 10.1016/j.ijid.2020.03.029. Epub 2020 Mar 16. No abstract available.
- Results Le Gal S, Toubas D, Totet A, Dalle F, Abou Bacar A, Le Meur Y, Nevez G; Anofel Association. Pneumocystis Infection Outbreaks in Organ Transplantation Units in France: A Nation-Wide Survey. Clin Infect Dis. 2020 May 6;70(10):2216-2220. doi: 10.1093/cid/ciz901.
- Results Desoubeaux G, Dominique M, Morio F, Thepault RA, Franck-Martel C, Tellier AC, Ferrandiere M, Hennequin C, Bernard L, Salame E, Bailly E, Chandenier J. Epidemiological Outbreaks of Pneumocystis jirovecii Pneumonia Are Not Limited to Kidney Transplant Recipients: Genotyping Confirms Common Source of Transmission in a Liver Transplantation Unit. J Clin Microbiol. 2016 May;54(5):1314-20. doi: 10.1128/JCM.00133-16. Epub 2016 Mar 2.
- Results Alanio A, Desoubeaux G, Sarfati C, Hamane S, Bergeron A, Azoulay E, Molina JM, Derouin F, Menotti J. Real-time PCR assay-based strategy for differentiation between active Pneumocystis jirovecii pneumonia and colonization in immunocompromised patients. Clin Microbiol Infect. 2011 Oct;17(10):1531-7. doi: 10.1111/j.1469-0691.2010.03400.x. Epub 2011 Apr 12.
- Results Nevez G, Le Gal S. Caspofungin and Pneumocystis Pneumonia: It Is Time To Go Ahead. Antimicrob Agents Chemother. 2019 Sep 23;63(10):e01296-19. doi: 10.1128/AAC.01296-19. Print 2019 Oct. No abstract available.
- Peghin M, Fishman JA, Grossi PA. Pneumocystis jiroveci : still troublesome to diagnose and treat. Curr Opin Infect Dis. 2025 Dec 1;38(6):522-529. doi: 10.1097/QCO.0000000000001155. Epub 2025 Oct 17.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Caspofungin | Other / unclassified | 5 mg | Inhaled |
| Subject | Caspofungin | Other / unclassified | 15 mg | Inhaled |
| Subject | Caspofungin | Other / unclassified | 50 mg | Inhaled |