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Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients (PIC)

Primary Purpose

Pneumocystis, Steroids, Immunocompromised Patient

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Methylprednisolone
Placebo
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pneumocystis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical ICURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Steroids

Arm Description

Saline serum, same volume as in the Experimental arm.

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

Outcomes

Primary Outcome Measures

Mortality
28 days mortality after the randomisation

Secondary Outcome Measures

Mortality
90 days mortality after the randomisation
Hospital mortality
Mortality at hospital discharge
ICU mortality
For patients admitted to ICU at ICU discharge
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
Duration of mechanical ventilation
Duration of mechanical ventilation invasive and/or non invasive
Occurrence of septic shock
septic shock is defined as need for vasopressor
acute kidney injury
KDIGO score >=1
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.
Hospital length of stay
Hospital length of stay at hospital discharge
ICU length of stay
ICU length of stay at ICU discharge
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

Full Information

First Posted
October 17, 2016
Last Updated
October 5, 2020
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02944045
Brief Title
Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients
Acronym
PIC
Official Title
Intérêt de la corticothérapie Dans la Pneumocystose Grave du Patient immunodéprimé Non VIH. Essai Prospectif Multicentrique Randomisé Contrôlé : PIC
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumocystis, Steroids, Immunocompromised Patient, Hematologic Neoplasms, Immunosuppressive Agents, Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
222 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline serum, same volume as in the Experimental arm.
Arm Title
Steroids
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
saline serum
Primary Outcome Measure Information:
Title
Mortality
Description
28 days mortality after the randomisation
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Mortality
Description
90 days mortality after the randomisation
Time Frame
Day 90
Title
Hospital mortality
Description
Mortality at hospital discharge
Time Frame
Day 120
Title
ICU mortality
Description
For patients admitted to ICU at ICU discharge
Time Frame
Day 90
Title
Acute respiratory failure
Description
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
Title
Duration of mechanical ventilation
Description
Duration of mechanical ventilation invasive and/or non invasive
Time Frame
Day 28
Title
Occurrence of septic shock
Description
septic shock is defined as need for vasopressor
Time Frame
Day 28
Title
acute kidney injury
Description
KDIGO score >=1
Time Frame
Day 28
Title
Hospital acquired infectious disease
Description
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
Title
Hospital length of stay
Description
Hospital length of stay at hospital discharge
Time Frame
Day 120
Title
ICU length of stay
Description
ICU length of stay at ICU discharge
Time Frame
Day 90
Title
Duration of Insulin treatment
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Virginie Lemiale, MD
Phone
142499419
Ext
+33
Email
virginie.lemiale@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Matthieu Resche-Rigon, MD PHD
Phone
142499742
Ext
+33
Email
matthieu.resche-rigon@univ-paris-diderot.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virginie Lemiale, MD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elie Azoulay, MD PHD
Organizational Affiliation
APHP
Official's Role
Study Director
Facility Information:
Facility Name
Medical ICU
City
Paris
ZIP/Postal Code
75010
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
virginie lemiale, MD
Phone
142499419
Ext
+33
Email
virginie.lemiale@aphp.fr

12. IPD Sharing Statement

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Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients

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