Informations générales (source: ClinicalTrials.gov)
Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC (PIC)
Interventional
Phase 3
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2017
octobre 2022
07 décembre 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Avicenne | LEMIALE Virginie | 18/04/2025 07:56:27 | Contacter | ||
| AP-HP - Hôpital Bichat | LEMIALE Virginie | 18/04/2025 07:56:27 | Contacter | ||
| AP-HP - Hôpital Cochin | LEMIALE Virginie | 18/04/2025 07:56:27 | Contacter | ||
| AP-HP - Hôpital Henri Mondor-Albert Chenevier | LEMIALE Virginie | 18/04/2025 07:56:27 | Contacter | ||
| AP-HP - Hôpital La Pitié-Salpêtrière | LEMIALE Virginie | 18/04/2025 07:56:27 | Contacter | ||
| AP-HP - Hôpital Lariboisiere-Fernand Widal | LEMIALE Virginie | 18/04/2025 07:56:27 | Contacter | ||
| AP-HP - Hôpital Necker-Enfants Malades | LEMIALE Virginie | 18/04/2025 07:56:27 | Contacter | ||
| AP-HP - Hôpital Saint Antoine | LEMIALE Virginie | 18/04/2025 07:56:27 | Contacter | ||
| AP-HP - Hôpital Tenon | LEMIALE Virginie | 18/04/2025 07:56:27 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CDS MEDICAL MGEN | virginie lemiale, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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