Clinical trial · Interventional
Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients
Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Pneumocystis jiroveci pneumonia (PcP) increased in non HIV immunocompromised patients. Mortality remains high for those patients with comorbidities (50% for patients with the most severe Pneumocystis pneumonia). Physiopathology, characteristics and outcome of PcP in non-HIV patients remains different from those in HIV patients. Steroids in HIV patients with PcP has been associated with decreased mortality but in non-HIV patients, adjunctive steroids remains controversy. Some retrospective studies in that field did not find any beneficial effects of steroids ((1mg/kg/jour d'Equivalent Prednisone (EP)). However, all the studies were retrospective, non randomised studies including various underlying disease and severity of PcP was variable. Moreover, dosage and delay of steroids were variable leading difficult to interpret all the results. The investigators want to demonstrate the beneficial effect of steroid during PcP in non-HiV immunocompromised patients with a double blinded randomised clinical trials comparing adjunctive steroids to placebo.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Immunocompromised Patient | — | UNRESOLVED | — |
| Immunosuppressive Agents | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Pneumocystis | — | UNRESOLVED | — |
| Steroids | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Methylprednisolone | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Saline serum, same volume as in the Experimental arm.
- interventionNames
- Drug: Placebo
- type
- EXPERIMENTAL
- label
- Steroids
- description
- Methylprednisolone intra veinous * Day 1 to 5 : 30mg twice per day * Day 6 to 10 : 30mg per day * Day 11 to 21 : 20mg per day
- interventionNames
- Drug: Methylprednisolone
Primary outcomes (1)
- measure
- Mortality
- timeFrame
- Day 28
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Severe PcP : 1 / interstitial acute pneumonia with possible or typical criteria for PcP and positive specimen for Pneumocystis jirovecii (excluding PCR) ; or interstitial acute pneumonia with typical criteria for PcP and positive PCR in respiratory specimen. 2/ Arterial pression of Oxygen (PaO2) \< 60 mmHg on room air need of 3 L/min oxygen for saturation \>92% or tachypnea\>30min need of mechanical ventilation for acute respiratory failure. * Treatment for PcP started for less than 7 days. * Non-HIV immunosuppression : malignant hematological disease, solid tumor cured for less than 5 years, allogenic stem cell transplant, Steroids (\>0.3mg/kg equivalent prednisone for more than 3 weeks or \> 20mg/days for more than one months) or other immunosuppressive treatment for more than one months or solid organ transplantation. * Signed inform consent by patient or relatives * Health insurance Exclusion Criteria: * HIV Serology HIV 1 or 2 positive * Need of steroid ≥1mg/kg/j equivalent prednisone for another pathology (acute Graft versus Host disease (GVH= for example) * Contra-indication for steroids * Pregnancy of breath-feeding * Denied to participate * No health insurance * tutelage
References
Publications (2)
- DERIVEDRosales-Chavez G, Martinez-Ayala P, Ambriz-Alarcon MA, Rubio-Mora BR, Arcos-Jimenez JC, Lopez-Yanez AM, Marin-Castaneda-Baron A, Briseno-Hernandez AA, Villafan-Bernal JR, Sanchez-Gutierrez JA, Briseno-Ramirez J. Adjunctive corticosteroids in non-HIV immunocompromised patients with Pneumocystis jirovecii pneumonia: a systematic review and meta-analysis. Ther Adv Infect Dis. 2026 Aug 4;13:20499361261468451. doi: 10.1177/20499361261468451. eCollection 2026 Jan-Dec. PMID 42558999
- DERIVEDLemiale V, Resche-Rigon M, Zerbib Y, Mokart D, De Prost N, Wallet F, Perez P, Kouatchet A, Argaud L, Decavele M, Pene F, Seguin A, Megarbane B, Calvet L, Picard M, Rigault G, Mariotte E, Bouadma L, Theodose I, Tamion F, Klouche K, Colin G, Nyunga M, Moreau AS, Azoulay E. Adjunctive corticosteroids in non-AIDS patients with severe Pneumocystis jirovecii pneumonia (PIC): a multicentre, double-blind, randomised controlled trial. Lancet Respir Med. 2025 Sep;13(9):800-808. doi: 10.1016/S2213-2600(25)00125-0. Epub 2025 Jul 10. PMID 40652952