NCT02944045

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 222 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Pneumocystis
• Steroids
• Immunocompromised Patient
• Hematologic Neoplasms
• Immunosuppressive Agents
• Neoplasms

Interventions

Type	Name	Description
DRUG	Methylprednisolone	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
DRUG	Placebo	saline serum

Timeline

• Start date: 2017-02-15
• Primary completion: 2021-10-01
• Completion: 2022-10-01
• First posted: 2016-10-25
• Last updated: 2020-10-06

Locations

1 site across 1 country: France