Corticosteroids for PJP in Non-HIV Immunocompromised Adults (NCT07152613) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Corticosteroids for PJP in Non-HIV Immunocompromised Adults
240 participantsStarted 2025-09-08
Plain-language summary
Pneumocystis jirovecii pneumonia (PJP) is one of the common severe complications in immunocompromised patients, with a reported mortality rate of 60-80%. Reducing mortality from PJP is crucial for improving outcomes in critically ill non-HIV immunocompromised patients and alleviating the burden on families and society. To address this medical challenge, our institution is conducting a study aimed at lowering PJP-related mortality. Specifically, we are performing an adaptive, randomized, open-label controlled trial in patients with severe PJP. The primary objective of this study is to scientifically evaluate the efficacy and safety of adjunctive corticosteroids at different dosages, in addition to early standard supportive care, for reducing mortality in severe PJP
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing whether corticosteroids — which are used to treat PCP pneumonia in HIV patients — also help non-HIV immunocompromised patients survive; given my specific condition and how I got immunocompromised, does my doctor think I'm the kind of patient this trial is designed for?
2Since the trial is still not yet recruiting, how long might it realistically be before I could even join, and is waiting for enrollment a safe option given how quickly PCP pneumonia can progress?
3The trial is measuring all-cause mortality at 28 days, which means it's focused on short-term survival — what does my doctor know about the risks of adding corticosteroids for someone in my situation, since the benefit-to-risk balance might be different for non-HIV patients than what's already established?
4This is a Phase 3 trial, which means the treatment is being tested at scale but isn't yet proven standard of care for non-HIV patients — should I be on standard PCP treatment right now rather than waiting to see if I qualify for this study?
5Are there any specific aspects of my immune suppression — like whether it's from chemotherapy, an organ transplant, or another cause — that would make corticosteroids more or less appropriate for me, based on what this trial is trying to find out?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.