Clinical Trial: Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC

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.


Detailed Summary:
Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Mortality [ Time Frame: Day 28 ]

28 days mortality after the randomisation


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality [ Time Frame: Day 90 ]
    90 days mortality after the randomisation
  • Hospital mortality [ Time Frame: Day 120 ]
    Mortality at hospital discharge
  • ICU mortality [ Time Frame: Day 90 ]
    For patients admitted to ICU at ICU discharge
  • Acute respiratory failure [ Time Frame: Day 28 ]

    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
  • Duration of mechanical ventilation [ Time Frame: Day 28 ]
    Duration of mechanical ventilation invasive and/or non invasive
  • Occurrence of septic shock [ Time Frame: Day 28 ]
    septic shock is defined as need for vasopressor
  • acute kidney injury [ Time Frame: Day 28 ]
    KDIGO score >=1
  • Hospital acquired infectious disease [ Time Frame: Day 28 ]

    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.

  • Hospital length of stay [ Time Frame: Day 120 ]
    Hospital length of stay at hospital discharge
  • ICU length of stay [ Time Frame: Day 90 ]
    ICU length of stay at ICU discharge
  • Duration of Insulin treatment [ Time Frame: Day 28 ]

    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


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: October 17, 2016
Date Started: February 15, 2017
Date Completion: October 2020
Last Updated: February 27, 2017
Last Verified: October 2016