Could steroids slash death rates from a rare pneumonia?
NCT ID NCT07152613
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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.
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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.
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A doctor treating you
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