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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002275-10 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Saline serum, same volume as in the Experimental arm. |
|
| Steroids | Experimental | Methylprednisolone intra veinous
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Methylprednisolone intra veinous
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 28 days mortality after the randomisation | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 90 days mortality after the randomisation | Day 90 |
| Hospital mortality | Mortality at hospital discharge | Day 120 |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Virginie Lemiale, MD | Contact | 142499419 | +33 | virginie.lemiale@aphp.fr |
| Matthieu Resche-Rigon, MD PHD | Contact | 142499742 | +33 | matthieu.resche-rigon@univ-paris-diderot.fr |
| Name | Affiliation | Role |
|---|---|---|
| Virginie Lemiale, MD | APHP | Principal Investigator |
| Elie Azoulay, MD PHD | APHP | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical ICU | Recruiting | Paris | 75010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40652952 | Derived | Lemiale 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. |
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| ID | Term |
|---|---|
| D011020 | Pneumonia, Pneumocystis |
| D019337 | Hematologic Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008172 | Lung Diseases, Fungal |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Placebo | Drug | saline serum |
|
| ICU mortality | For patients admitted to ICU at ICU discharge | Day 90 |
| Acute respiratory failure | Acute respiratory failure during treatment defined by one of those criteria within 28 days :
| Day 28 |
| Duration of mechanical ventilation | Duration of mechanical ventilation invasive and/or non invasive | Day 28 |
| Occurrence of septic shock | septic shock is defined as need for vasopressor | Day 28 |
| acute kidney injury | KDIGO score >=1 | Day 28 |
| Hospital acquired infectious disease | Global incidence incidence of infections. Incidence of pulmonary or extra-pulmonary infections. Incidence of bacterial, viral and fungal infections. Diagnosis of infectious disease will be defined by the need of treatment. | Day 28 |
| Hospital length of stay | Hospital length of stay at hospital discharge | Day 120 |
| ICU length of stay | ICU length of stay at ICU discharge | Day 90 |
| Duration of Insulin treatment | Insulin treatment is defined :
| Day 28 |
| D016720 |
| Pneumocystis Infections |
| D012141 | Respiratory Tract Infections |
| D011014 | Pneumonia |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |