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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02944045
Other study ID # P150961
Secondary ID 2016-002275-10
Status Recruiting
Phase Phase 3
First received
Last updated
Start date February 15, 2017
Est. completion date October 2022

Study information

Verified date October 2020
Source Assistance Publique - Hôpitaux de Paris
Contact Virginie Lemiale, MD
Phone 142499419
Email virginie.lemiale@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 222
Est. completion date October 2022
Est. primary completion date October 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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
Placebo
saline serum

Locations

Country Name City State
France Medical ICU Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality 28 days mortality after the randomisation Day 28
Secondary Mortality 90 days mortality after the randomisation Day 90
Secondary Hospital mortality Mortality at hospital discharge Day 120
Secondary ICU mortality For patients admitted to ICU at ICU discharge Day 90
Secondary 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
Day 28
Secondary Duration of mechanical ventilation Duration of mechanical ventilation invasive and/or non invasive Day 28
Secondary Occurrence of septic shock septic shock is defined as need for vasopressor Day 28
Secondary acute kidney injury KDIGO score >=1 Day 28
Secondary 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.
Day 28
Secondary Hospital length of stay Hospital length of stay at hospital discharge Day 120
Secondary ICU length of stay ICU length of stay at ICU discharge Day 90
Secondary 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
Day 28
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