A Phase 3 interventional study of Echinocandins and Placebo (0.9% Sodium chloride) infusion in Pneumocystis Jirovecii Pneumonia, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Phase 3, Interventional, and Treatment
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.
Pneumocystis jirovecii pneumonia (PCP) is a serious lung infection that mainly affects people with weakened immune systems, including people with HIV, cancer, organ transplants, immune-system disorders, or medicines that suppress the immune system. Severe PCP can cause low oxygen levels and may require intensive respiratory support. Although medicines are available to treat PCP, evidence supporting treatment approaches remains limited. Echinocandins are antifungal medicines that act on a stage of the Pneumocystis organism containing beta-1,3-D-glucan. Laboratory findings and retrospective clinical data provide a rationale for studying this approach, but its benefit in severe PCP has not been established in a definitive randomized controlled trial.
This Phase III, randomized, placebo-controlled superiority trial is part of the SPIRIT-PCP platform trial. The purpose is to determine whether adding an echinocandin to standard treatment for severe PCP improves clinical outcomes compared with standard treatment plus a matching placebo.
Eligible adults hospitalized with severe PCP who meet the platform and ECHINO-PCP eligibility criteria will be randomly assigned in a 1:1 ratio to one of two groups. The echinocandin group will receive standard anti-PCP therapy plus an echinocandin antifungal medication. The placebo group will receive standard anti-PCP therapy plus a matching intravenous placebo consisting of 0.9% sodium chloride. The echinocandin used at each participating site will be selected from the study-approved products, which include caspofungin, micafungin, and anidulafungin. The study is blinded, meaning that participants and their treating and study teams generally will not know which treatment has been assigned.
Study treatment will be administered by intravenous infusion until hospital discharge or for 7 days, whichever occurs first. Participants will be followed for up to 180 days from the beginning of PCP treatment.
The primary outcome will be assessed by Day 30 and will compare the groups using a hierarchical composite of clinical outcomes, including death, the need for new extracorporeal membrane oxygenation (ECMO) or invasive or non-invasive mechanical ventilation, severe medication-related reactions considered probably related to treatment, changes in PCP treatment because of presumed treatment failure or a probable medication-related reaction, and hospital length of stay among survivors.
Secondary outcomes will include the individual components of the primary outcome, medication-related adverse reactions, oxygen and ventilation requirements, and hospital length of stay. Longer-term outcomes will include quality of life at Days 30 and 180, recurrence of PCP infection, and death from any cause by Day 180. Study information will be collected during hospitalization, through medical records and follow-up assessments, and through planned follow-up contacts.
The findings may help determine whether adding an echinocandin to standard PCP treatment improves clinical outcomes for adults hospitalized with severe PCP.
108 studies on the registry are indexed under Pneumonia, Pneumocystis; 16 are open to participants now.
This study's planned enrollment of 416 is above the median of 231 across 56 interventional studies indexed under Pneumonia, Pneumocystis.
Browse Pneumonia, Pneumocystis studies →McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 421 studies on the registry; 105 are open to participants now.
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Inclusion Criteria
Clinical Exclusion Criteria
Administrative Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Echinocandin IV + standard anti-PCP therapy until discharge or 7 days, whichever occurs first.
Drug: Echinocandins
0.9% sodium chloride IV placebo + standard anti-PCP therapy until discharge or 7 days, whichever occurs first.
Drug: Placebo (0.9% Sodium chloride) infusion
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.
0.9% sodium chloride IV.
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.
Time frame: Day 30
Proportion of participants who died
Proportion of participants who died
Time frame: Through Day 30
Hospital length of stay among survivors
Length of hospital stay among participants who survive.
Time frame: Through Day 30
CTCAE grade 3 and 4 adverse drug reactions
Proportion of participants with CTCAE grade 3 or 4 adverse drug reactions considered at least probably related to treatment, by organ system.
Time frame: Through Day 30
Time to occurrence of primary outcome components
Time to each component of the primary outcome, including death, new respiratory support, treatment changes, and severe adverse drug reactions.
Time frame: Through Day 30
Proportion of patients requiring new ECMO
Proportion of patients requiring new extracorporeal membrane oxygenation
Time frame: Through Day 30
Proportion of patients requiring new mechanical ventilation
Proportion of patients requiring new mechanical ventilation
Time frame: Through Day 30
Proportion of patients with CTCAE grade 4 adverse drug reactions considered at least probably related to treatment
Proportion of patients with CTCAE grade 4 adverse drug reactions considered at least probably related to treatment
Time frame: Through day 30
Proportion of patients requiring new non-invasive ventilation,
Proportion of patients requiring new non-invasive ventilation,
Time frame: Through day 30
Proportion of patients with change in PCP therapy due to presumed treatment failure or a probable adverse drug reaction
Proportion of patients with change in PCP therapy due to presumed treatment failure or a probable adverse drug reaction
Time frame: Through day 30
Health-related quality of life
Quality of life measured using the EQ-5D-5L (EuroQol 5-Dimension 5-Level) questionnaire The EQ-5D-5L measures health-related quality of life using a two-part self-report questionnaire that evaluates functional status across five core dimensions and records an overall self-rated health score
Time frame: Days 30 and 180
Recurrence of PCP infection
Occurrence of recurrent Pneumocystis jirovecii pneumonia.
Time frame: Through Day 180
All-cause mortality
Death from any cause.
Time frame: Through Day 180
Quality of life using the visual analogue scale (VAS)
VAS rates overall health from 0 (worst imaginable health) to 100 (best imaginable health), where higher values are better
Time frame: Day 30, day 180
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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McGill University Health Centre/Research Institute of the McGill University Health Centre →