A Phase 3 interventional study of Methylprednisolone and Placebo in Pneumocystis, Steroids and Immunocompromised Patient, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-06.
Sponsored by Assistance Publique - Hôpitaux de Paris · Phase 3, Interventional, and Treatment
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.
107 studies on the registry are indexed under Pneumonia, Pneumocystis; 15 are open to participants now.
This study's planned enrollment of 222 is close to the median of 231 across 52 interventional studies indexed under Pneumonia, Pneumocystis.
Browse Pneumonia, Pneumocystis studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Saline serum, same volume as in the Experimental arm.
Drug: Placebo
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
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
saline serum
Mortality
28 days mortality after the randomisation
Time frame: Day 28
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
This study is status unknown, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris