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Shorter steroid course for severe PCP? new trial aims to find out

NCT ID NCT07328984

Disease control Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how long steroids should be given to adults with severe Pneumocystis pneumonia (PCP), a serious lung infection common in people with weakened immune systems. About 416 participants who improve within 10 days will either stop steroids early or continue for 21 days. The goal is to see if stopping sooner reduces side effects like infections or diabetes without harming recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
systemic corticosteroids
What this could lead to
If successful, this could show that a shorter course of steroids is safer and just as effective for severe PCP, potentially changing standard treatment guidelines.
What could go wrong
This is a Phase 4 trial, so the drugs are already approved, but the optimal duration is unknown. The results may not apply to all patient groups, and earlier steroid stopping could increase the risk of relapse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 416 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥18 years * Proven or probable Pneumocystis jirovecii pneumonia * Severe PCP requiring supplemental oxygen (e.g., ≥4 L/min or ≥35% FiO₂ to maintain SpO₂ ≥94%) * Planned or receiving adjunctive systemic corticosteroid therapy for severe PCP * Clinical recovery by day 10 of steroid therapy: breathing room air for ≥6 hours * Able to provide informed consent (or per local requirements) Exclusion Criteria: * Persistent hypoxemia or ongoing oxygen requirement at day 10 * Clinical deterioration prior to randomization * Treating clinician determines steroids must be continued or stopped immediately for medical reasons * Anticipated death within 48 hours * Inability or unwillingness to complete follow-up through day 180

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Conditions

The condition(s) this trial relates to.

Infections Pneumocystis infectious disease pneumocystosis pneumonia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pneumocystis Pneumocystis carinii; infection, resulting from HIV disease Pneumocystis jiroveci pneumonia Pneumocystis jirovecii infection Pneumocystis pneumonia Pneumocystosis associated with AIDS Pneumocystosis; pneumonia (etiology)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • McGill university Health Centre (Royal victoria Hospital and Montreal General Hospital

    Montreal, Quebec, H4A 3J1, Canada

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