Effect of Steroids During Pneumocystis Infection Among Non HIV Immunocompromised Patients

Neoplasms Clinical Trial

— PIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02944045
• Other study ID #: P150961
• Secondary ID: 2016-002275-10
• Status: Recruiting
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Immunocompromised Patient
• Immunosuppressive Agents
• Neoplasms
• Pneumocystis
• Pneumonia, Pneumocystis
• Steroids

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