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Pneumocystis Jirovecii PneumoniaPhase 3ECHINO-PCPNCT07900373

Echinocandin Added to Standard Treatment for Severe Pneumocystis Pneumonia

A Phase 3 study testing Echinocandins in people with Pneumocystis Jirovecii Pneumonia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Preclinical studies and retrospective clinical data suggest that adjunctive echinocandin therapy may improve outcomes in adults with severe Pneumocystis jirovecii pneumonia (PCP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pneumocystis Jirovecii Pneumonia
What is being tested?
Echinocandins
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
416 participants
Where
1 siteCanada
Study dates
1 Apr 2027to 31 Dec 2032
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Immunocompromised adults (≥18 years old) in an emergency department or hospital with a proven or probable diagnosis of PCP.
  • Severe PCP, defined as proven or probable PCP with new or increased PCP-attributable hypoxemic respiratory failure meeting at least one of the following criteria: a requirement for ≥4 L/min supplemental oxygen by nasal cannula to maintain oxygenation >94%; a requirement for FiO₂ ≥0.35 via a controlled oxygen-delivery device; or a requirement for advanced respiratory support, including invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). For patients with chronic baseline oxygen use, the increased support must be attributable to PCP.
  • Currently receiving, or eligible to receive, systemic anti-PCP therapy for the current episode. Patients receiving empiric PCP treatment may be enrolled before microbiological or pathological results are available if results are expected within 1 week.
  • No later than 48 hours after screening for inclusion and before more than 3 days of PCP therapy have elapsed.
  • Provision of informed consent by the participant or substitute decision maker, as locally applicable.
  • Clinical Exclusion Criteria
Show all 19Show fewer
  • More than 3 days of effective anti-PCP therapy before enrolment in ECHINO-PCP.
  • Another infection or clinical indication that independently requires echinocandin therapy.
  • Known allergy or hypersensitivity to echinocandins.
  • Receipt of more than 24 hours of caspofungin, micafungin, or anidulafungin, or receipt of one dose of rezafungin, before enrolment.
  • PCP is no longer considered the most likely diagnosis at the time of randomization.
  • PCP therapy has already been escalated or changed for presumed treatment failure before enrolment.
  • Death is deemed imminent (<48 hours), as determined by the treating team and site investigator.
  • Treatment with antifungals is inconsistent with the patient's advanced care directives.
  • Administrative Exclusion Criteria
  • Inability to obtain informed consent, or refusal to consent by the patient or substitute decision maker.
  • Treating team declines participation.
  • Inability to ensure reliable follow-up (e.g., lack of means of communication or patient non-resident of the jurisdiction).
  • Prior enrolment in ECHINO-PCP.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Emily G. McDonald, MD MSc contact

514-934-1934 ext. 53333

emily.mcdonald@mcgill.ca

Canada1 site
  • McGill University Health Centre

    Montreal, Quebec, H4A0B1

    Naisha Y. Nicolas, MSc, 514-934-1934 ext. 53333, naisha.nicolas@rimuhc.ca

    Emily G. McDonald, MD, 514-934-1934 ext. 53333, emily.mcdonald@mcgill.ca

Other trials in Canada

About this study

Official title: Adjunctive Echinocandin for Severe Pneumocystis Jirovecii Pneumonia (ECHINO-PCP)

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.
Read the detailed description

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.

Being tested
Echinocandins, Placebo (0.9% Sodium chloride) infusion
Keywords
Severe PCP, Pneumocystis jirovecii, Echinocandin, Caspofungin, Micafungin, Anidulafungin
Medical subject headings
Pneumonia, Pneumocystis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EchinocandinsDrug

    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.

  • Placebo (0.9% Sodium chloride) infusionDrug

    0.9% sodium chloride IV.

Study groups in NCT07900373
Study groupRoleWhat they receive
EchinocandinExperimentalEchinocandin IV + standard anti-PCP therapy until discharge or 7 days, whichever occurs first.
Receives: Drug: Echinocandins
PlaceboPlacebo comparator0.9% sodium chloride IV placebo + standard anti-PCP therapy until discharge or 7 days, whichever occurs first.
Receives: Drug: Placebo (0.9% Sodium chloride) infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 30

Secondary outcomes (9)
  1. Proportion of participants who died

    Proportion of participants who died

    Measured: Through Day 30

  2. Hospital length of stay among survivors

    Length of hospital stay among participants who survive.

    Measured: Through Day 30

  3. 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.

    Measured: Through Day 30

  4. 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.

    Measured: Through Day 30

  5. Proportion of patients requiring new ECMO

    Proportion of patients requiring new extracorporeal membrane oxygenation

    Measured: Through Day 30

  6. Proportion of patients requiring new mechanical ventilation

    Proportion of patients requiring new mechanical ventilation

    Measured: Through Day 30

  7. 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

    Measured: Through day 30

  8. Proportion of patients requiring new non-invasive ventilation,

    Proportion of patients requiring new non-invasive ventilation,

    Measured: Through day 30

  9. 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

    Measured: Through day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study start1 Apr 2027 (estimated)
  3. Primary completion1 Apr 2032 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomized 1:1 to receive adjunctive echinocandin plus standard anti-PCP therapy or matching intravenous placebo plus standard anti-PCP therapy.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
416 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07900373
Sponsor's protocol ID
2027-13078
Acronym
ECHINO-PCP
Status last verified
Nov 2026
First submitted
21 Oct 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39117103
  • 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.

    PubMed 20126455
  • 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.

    PubMed 41163137
  • 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.

    PubMed 35740126
  • 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.

    PubMed 34988242

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Echinocandins in people with Pneumocystis Jirovecii Pneumonia, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Naisha Y. Nicolas, MSc (514-934-1934 ext. 53333, naisha.nicolas@rimuhc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hierarchical Composite Clinical Outcome Assessed Using the Win Odds/Win Ratio (time frame: Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07900373, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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