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Could steroids slash death rates from a rare pneumonia?

NCT ID NCT07152613

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tests whether adding corticosteroids (low or moderate dose) to standard care can reduce deaths from severe Pneumocystis pneumonia (PJP) in non-HIV patients in the ICU. PJP has a very high death rate of 60-80% in this group. The trial will compare two steroid doses against a placebo in 240 adults to find the safest and most effective approach.

What this could mean

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

Active substance
Methylprednisolone (a corticosteroid)
What this could lead to
If successful, this could provide a clear dosing strategy for corticosteroids to lower the high death rate (60-80%) from severe PJP pneumonia in non-HIV patients.
What could go wrong
This is an early-stage trial with only 240 participants, so results may not apply to all patients. Corticosteroids can also increase infection risk or other side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 240 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

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. Admission to the Intensive Care Unit (ICU). Meeting the diagnostic criteria for community-acquired pneumonia (CAP). Meeting at least one of the major diagnostic criteria for severe pneumonia: (i) Requirement for endotracheal intubation and mechanical ventilation; (ii) Septic shock requiring vasopressor therapy after adequate fluid resuscitation. Or simultaneously fulfilling three of the minor criteria: (i) Respiratory rate ≥ 30 breaths/min; (ii) PaO₂/FiO₂ ≤ 250 mmHg; (iii) Multilobar infiltrates; (iv) Altered mental status and/or disorientation; (v) Blood urea nitrogen ≥ 20 mg/dL (7.12 mmol/L); (vi) Leukopenia (white blood cell count \< 4 × 10⁹/L); (vii) Thrombocytopenia (platelet count \< 100 × 10⁹/L); (viii) Hypothermia (core temperature \< 36 °C); (ix) Hypotension (systolic blood pressure \< 90 mmHg) requiring aggressive fluid resuscitation. Confirmed PJ etiology: at least one positive nucleic acid test (PCR) or next-generation sequencing (NGS) result for Pneumocystis jirovecii in respiratory specimens (respiratory secretions, throat swabs, or bronchoalveolar lavage fluid). Severe community-acquired pneumonia (SCAP) patients admitted to the emergency department/ward/ICU due to respiratory failure within \< 72 hours. Signed informed consent. Exclusion Criteria: * Age \< 18 years. * Pregnant or breastfeeding women. * HIV infection. * No targeted PJP therapy administered or therapy not according to standard protocol. * Diagnosis of PJP \>7 days prior to MICU admission. * Use of corticosteroids for PJP prior to MICU admission. * Requirement for high-dose baseline corticosteroid therapy for other conditions (prednisone ≥ 0.5 mg/kg/day or equivalent). * Any contraindication to corticosteroid use as judged by the investigator (e.g., severe concurrent infectious disease, severe gastrointestinal bleeding). * Discharge or death within 48 hours after intervention. * Participation in other clinical studies or refusal to participate in this study.

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Conditions

The condition(s) this trial relates to.

Community-Acquired Pneumonia pneumocystosis

As listed by the trial registrant

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

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.