NCT07900373|Not Yet RecruitingPhase 3DMC
Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia
ECHINO-PCP
Adjunctive Echinocandin for Severe Pneumocystis Jirovecii Pneumonia (ECHINO-PCP)
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Sponsor study identifier
interventional
416
1 country
1
Study Start
April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Preclinical studies and retrospective clinical data suggest that adjunctive echinocandin therapy may improve outcomes in adults with severe Pneumocystis jirovecii pneumonia (PCP). However, the benefit of adding an echinocandin to standard PCP treatment has not been established in a definitive randomized controlled trial. The aim of this trial is: 1\. In adults hospitalized with severe PCP, to determine whether adding an echinocandin to standard anti-PCP therapy improves net clinical outcomes by Day 30 compared with standard anti-PCP therapy plus matching placebo.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 21, 2026
Actual (reported)October 28, 2026
Actual (reported)April 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Hierarchical Composite Clinical Outcome Assessed Using the Win Odds/Win Ratio
Hierarchical composite of death, new extracorporeal membrane oxygenation (ECMO), new invasive mechanical ventilation, CTCAE grade 4 adverse drug reactions considered at least probably related to treatment, new non-invasive ventilation, change in PCP therapy due to presumed treatment failure or a probable adverse drug reaction, and hospital length of stay among survivors. Assessed using the Win Odds approach.
Day 30
Proportion of participants who died
Through Day 30
Hospital length of stay among survivors
Through Day 30
CTCAE grade 3 and 4 adverse drug reactions
Through Day 30
Time to occurrence of primary outcome components
Through Day 30
Proportion of patients requiring new ECMO
Through Day 30
Health-related quality of life
Days 30 and 180
Recurrence of PCP infection
Through Day 180
All-cause mortality
Through Day 180
Echinocandin IV + standard anti-PCP therapy until discharge or 7 days, whichever occurs first.
0.9% sodium chloride IV placebo + standard anti-PCP therapy until discharge or 7 days, whichever occurs first.
Caspofungin 70 mg IV Day 1, then 50 mg daily; micafungin 100 mg IV daily; or anidulafungin 200 mg IV Day 1, then 100 mg daily.
McGill University Health Centre
Montreal, Quebec, H4A0B1, Canada
Taniguchi J, Aso S, Matsui H, Fushimi K, Yasunaga H. Trimethoprim-sulfamethoxazole combined with echinocandins versus trimethoprim-sulfamethoxazole alone for Pneumocystis pneumonia in patients without human immunodeficiency virus infection: A nationwide retrospective cohort study. J Infect Chemother. 2025 Jan;31(1):102489. doi: 10.1016/j.jiac.2024.08.004. Epub 2024 Aug 6.
Cushion MT, Linke MJ, Ashbaugh A, Sesterhenn T, Collins MS, Lynch K, Brubaker R, Walzer PD. Echinocandin treatment of pneumocystis pneumonia in rodent models depletes cysts leaving trophic burdens that cannot transmit the infection. PLoS One. 2010 Jan 29;5(1):e8524. doi: 10.1371/journal.pone.0008524.
Emily G. McDonald, MD MSc
McGill University Health Centre/Research Institute of the McGill University Health Centre
Todd C. Lee, MD MPH
McGill University Health Centre/Research Institute of the McGill University Health Centre
First Submitted
October 21, 2026
First Posted
October 28, 2026
Study Start
April 1, 2027
Contact the study team to confirm eligibility.
Xie J, Gao A, Zhang W, Zhao D, Liu W. Efficacy and safety of echinocandins combined with Trimethoprim-Sulfamethoxazole as first-line treatment for Pneumocystis pneumonia in HIV-infected and non-HIV-infected patients. BMC Infect Dis. 2025 Oct 29;25(1):1443. doi: 10.1186/s12879-025-11857-8.
Kato H, Hagihara M, Asai N, Umemura T, Shibata Y, Hirai J, Yamagishi Y, Iwamoto T, Mikamo H. Efficacy of Trimethoprim-Sulfamethoxazole in Combination with an Echinocandin as a First-Line Treatment Option for Pneumocystis Pneumonia: A Systematic Review and Meta-Analysis. Antibiotics (Basel). 2022 May 26;11(6):719. doi: 10.3390/antibiotics11060719.
McDonald EG, Butler-Laporte G, Del Corpo O, Hsu JM, Lawandi A, Senecal J, Sohani ZN, Cheng MP, Lee TC. On the Treatment of Pneumocystis jirovecii Pneumonia: Current Practice Based on Outdated Evidence. Open Forum Infect Dis. 2021 Oct 29;8(12):ofab545. doi: 10.1093/ofid/ofab545. eCollection 2021 Dec.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2026
Record last verified: 2026-10
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