Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients

Assistance Publique - Hôpitaux de Paris222 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

222

Conditions

Pneumocystis Steroids Immunocompromised Patient

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mortality

28 days mortality after the randomisation

Time frame: Day 28

Secondary Outcomes

Mortality

90 days mortality after the randomisation

Time frame: Day 90

Hospital mortality

Mortality at hospital discharge

Time frame: Day 120

ICU mortality

For patients admitted to ICU at ICU discharge

Time frame: Day 90

Acute respiratory failure

Acute respiratory failure during treatment defined by one of those criteria within 28 days : * Increased need of oxygen (more than 9 l/min of high flow nasal oxygen with Inspired Fraction of Oxygen (fiO2) \>50%) * Admission to ICU after randomisation * Need of mechanical ventilation (invasive or non invasive) or high flow nasal oxygen

Time frame: Day 28

Duration of mechanical ventilation

Duration of mechanical ventilation invasive and/or non invasive

Time frame: Day 28

Occurrence of septic shock

septic shock is defined as need for vasopressor

Time frame: Day 28

acute kidney injury

KDIGO score \>=1

Time frame: 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.

Time frame: Day 28

Hospital length of stay

Hospital length of stay at hospital discharge

Time frame: Day 120

ICU length of stay

ICU length of stay at ICU discharge

Time frame: Day 90

Duration of Insulin treatment

Insulin treatment is defined : * patient without insulin treatment before study : start of insulin therapy * patient treated with insulin before study : increased dose (\>30%) of insulin

Time frame: Day 28

Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts