Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients

Last updated: October 5, 2020
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

3

Condition

Organ Transplant

Hematologic Neoplasms

Neoplasms

Treatment

N/A

Clinical Study ID

NCT02944045
P150961
2016-002275-10
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 18 years

  • Severe PcP : 1 / interstitial acute pneumonia with possible or typical criteria forPcP and positive specimen for Pneumocystis jirovecii (excluding PCR) ; or interstitialacute pneumonia with typical criteria for PcP and positive PCR in respiratoryspecimen. 2/ Arterial pression of Oxygen (PaO2) < 60 mmHg on room air need of 3 L/minoxygen for saturation >92% or tachypnea>30min need of mechanical ventilation for acuterespiratory failure.

  • Treatment for PcP started for less than 7 days.

  • Non-HIV immunosuppression : malignant hematological disease, solid tumor cured forless than 5 years, allogenic stem cell transplant, Steroids (>0.3mg/kg equivalentprednisone for more than 3 weeks or > 20mg/days for more than one months) or otherimmunosuppressive treatment for more than one months or solid organ transplantation.

  • Signed inform consent by patient or relatives

  • Health insurance

Exclusion

Exclusion Criteria:

  • HIV Serology HIV 1 or 2 positive

  • Need of steroid ≥1mg/kg/j equivalent prednisone for another pathology (acute Graftversus Host disease (GVH= for example)

  • Contra-indication for steroids

  • Pregnancy of breath-feeding

  • Denied to participate

  • No health insurance

  • tutelage

Study Design

Total Participants: 222
Study Start date:
February 15, 2017
Estimated Completion Date:
October 31, 2022

Connect with a study center

  • Medical ICU

    Paris, 75010
    France

    Active - Recruiting

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