Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients

NCT02944045 | Unknown Phase 3

• 2 other identifiers: P1509612016-002275-10
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Mortality

  28 days mortality after the randomisation

  Day 28

Secondary Outcomes (11)

• Mortality

  Day 90

• Hospital mortality

  Day 120

• ICU mortality

  Day 90

• Acute respiratory failure

  Day 28

• Duration of mechanical ventilation

  Day 28

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline serum, same volume as in the Experimental arm.

Drug: Placebo

Steroids

EXPERIMENTAL

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: Methylprednisolone

Interventions

Methylprednisolone 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

Steroids

Placebo DRUG

saline serum

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Medical ICU

Paris, 75010, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 40652952 DERIVED

MeSH Terms

Conditions

Pneumonia, Pneumocystis; Hematologic Neoplasms; Neoplasms

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Lung Diseases, Fungal; Mycoses; Bacterial Infections and Mycoses; Infections; Pneumocystis Infections; Respiratory Tract Infections; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Virginie Lemiale, MD

  APHP

  PRINCIPAL INVESTIGATOR

• Elie Azoulay, MD PHD

  APHP

  STUDY DIRECTOR

Central Study Contacts

Virginie Lemiale, MD

CONTACT

142499419; virginie.lemiale@aphp.fr

Matthieu Resche-Rigon, MD PHD

CONTACT

142499742; matthieu.resche-rigon@univ-paris-diderot.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 25, 2016
• Study Start: February 15, 2017
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: October 6, 2020

Record last verified: 2020-10

Locations

FR (1)