NCT07152613Not yet recruitingPhase 3
Corticosteroids for PJP in Non-HIV Immunocompromised Adults
An Embedded Adaptive Randomized Controlled Trial of Corticosteroid Therapy for Pneumocystis Jirovecii Pneumonia (PJP) in Non-HIV Immunocompromised Patients
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 240 (estimated)
- First submitted
- 26 Aug 2025
- Start date
- 8 Sept 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Qingyuan Zhan
- NCT number
- NCT07152613
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 240
- From 8 Sept 2025 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Any contraindication to corticosteroid use as judged by the investigator (e.g., severe concurrent infectious disease, severe gastrointestinal bleeding).
Other illness
- HIV infection.
- Requirement for high-dose baseline corticosteroid therapy for other conditions (prednisone ≥ 0.5 mg/kg/day or equivalent).
Age
- Age \< 18 years.
Other
- Pregnant or breastfeeding women.
- Discharge or death within 48 hours after intervention.
- Participation in other clinical studies or refusal to participate in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.