Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients

NCT ID: NCT02944045

Last Updated: 2020-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-15
• Study Completion Date: 2022-10-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Saline serum, same volume as in the Experimental arm.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

saline serum

Steroids

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

Group Type: EXPERIMENTAL

Methylprednisolone

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Placebo

saline serum

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Virginie Lemiale, MD

Role: PRINCIPAL_INVESTIGATOR

APHP

Elie Azoulay, MD PHD

Role: STUDY_DIRECTOR

APHP

Locations

Medical ICU

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Virginie Lemiale, MD

Role: CONTACT

virginie.lemiale@aphp.fr

142499419 ext. +33

Matthieu Resche-Rigon, MD PHD

Role: CONTACT

matthieu.resche-rigon@univ-paris-diderot.fr

142499742 ext. +33

Facility Contacts

virginie lemiale, MD

Role: primary

virginie.lemiale@aphp.fr

142499419 ext. +33

References

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.

Reference Type: DERIVED

PMID: 40652952 (View on PubMed)

Other Identifiers

2016-002275-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P150961

Identifier Type: -

Identifier Source: org_study_id