Ongoing Clinical Research Protocols (PHRCs/national grant) at Grrr-OH Centres
PIC (Virginie Lemiale)
Interest of corticosteroid therapy in severe pneumocystis in immunocompromised non-HIV patients. Prospective multicentre randomised controlled trial.
The primary objective of this trial is to demonstrate the superiority of adjuvant corticosteroid therapy in the management of severe pneumocystisis in immunocompromised non-HIV patients on 28-day mortality.
- Severe pneumocystis pneumocystis defined by interstitial pneumonia with criteria for typical or possible pneumocystis pneumonia and a positive Pneumocystis jirovecii sample other than PCR, like sputum or BAL, and by PaO2<60mmHg in ambient air or requiring 3L/min of oxygen for saturation >92% or tachypnea >30min or requiring mechanical ventilation for acute respiratory failure.
- Pneumocystis treated with antibiotics for less than 7 days.
- Immunosuppression defined by a solid or hematological malignant disease under treatment or in remission for less than 5 years, an allograft of hematopoietic stem cells, treatment with corticosteroid therapy (>0.3mg/kg of prednisone equivalent for more than 3 weeks or >20mg/day for more than 1 month) or with another immunosuppressant for more than 1 month, a solid organ transplant.
TRANSPORT (Frédéric Pène)
Red Blood Cell Transfusion Strategy in Resuscitation of Septic Shock in the Oncologic Hematology Patient: Multicentre Randomized Trial
Improvement in tissue oxygenation assessed by the percentage of patients with normalization (lactate 2 mmol/L) or relative decrease (clearance) of arterial lactate greater than 30% at 12 hours after randomization according to the formula (lactate H0 – lactate H12)/lactate H0*100
- Male or female, 18 years of age or older
- Patient with a solid tumour or progressive malignant haemopathy requiring therapeutic management or close follow-up (complete remission for less than 2 years).
- Clinically suspected or microbiologically confirmed infection
- Circulatory failure requiring support with vasopressor drugs (norepinephrine or adrenaline 0.1 μg/kg/min) to maintain an average blood pressure ≥ 65 mmHg, for more than 1 hour and for less than 24 hours
- Tissue hypoperfusion manifested by arterial lactate > 2 mmol/L within 3 hours prior to inclusion
- Hemoglobin level < 9 g/dL before or after vascular filling
DEPOH (Djamel Mokart)
ANTIBIOTIC DE-ESCALATION IN ONCO-HEMATOLOGY PATIENTS ADMITTED TO INTENSIVE CARE UNIT FOR SEPSIS OR SEPTIC SHOCK – DéPOH-IPC 2015-022
The main objective of the study is to demonstrate that an antibiotic de-escalation strategy is noninferior to the continuation of broad-spectrum antibiotics in terms of hospital mortality (allcause mortality) in septic onco-hematology patients admitted to the ICU.
- A suspected infection
- And an acute increase of ≥ 2 SOFA points (a proxy for organ dysfunction)
· Septic shock:
-and vasopressor therapy needed to elevate MAP ≥65 mm Hg and lactate >2
mmol/L despite adequate fluid resuscitation
- Patient treated with an empirical antibiotic treatment,
- Patient with at least one microbiological sample collected within the first 48 hours following the
diagnosis of sepsis in ICU
- Patient with an identified infectious site according to the definitions,
- Patient with an identified bacteria after microbiological examination,
- Patient affiliated to the national French statutory healthcare insurance system or beneficiary of
EFRAIM 2 (Élie Azoulay)
Empirical steroids and/or antifungals in immunocompromised patients with acute respiratory failure from undetermined etiology: a multicenter double-blind randomized controlled trial.
Main objective is to reduce the 90-day mortality in immunocompromised patients with ARF from undetermined etiology at day-3. The intervention would evaluate the impact of steroids ± isavuconazole for 14 days or until ICU discharge.
- Known immunosuppression: a) immunosuppressive drug or long term (>3 months) or high dose (>0.5 mg/kg/day) steroids; b) solid organ transplant; c) solid tumor; d) hematological malignancies; e) primary immune deficiency
- ICU admission for acute respiratory failure as defined by a) respiratory distress with tachypnea (respiratory rate>30/min); b) cyanosis; c) laboured breathing; d) Need for more than 6l of standard oxygen to maintain SpO2>95%, or for high flow oxygen, non-invasive or invasive mechanical ventilation;
- No established ARFetiology at day 3
EXPERTIS (Élie Azoulay)
A Telemedicine Improvement Program for the Management of Acute Respiratory Failure Patients with Hematologic Oncohaematology: A Randomized Trial in Cluster EXPERT-IS.
Objective is to evaluate whether combining three knowledge-transfer methods (videoconference-based forum, educational sessions, and dissemination of published work) increases the survival of cancer patients managed in low-volume centres to the values seen in high-volume centres. The main endpoint is all-cause mortality at hospital discharge.
- Active malignancy
- ICUs seeking for an advice must admit fewer than 30 patients with active cancer per year
- Patients has been urgently admitted in the ICU for a life threatening complication of the malignancy or its treatments.
COMBINATION LOCK (Michael Darmon)
Influence of dual therapy aminoglycoside and protective isolation on the outcomes of neutropenic patients admitted to intensive care units with sepsis: a randomized, double-blind, factorial design study
- Sepsis or septic shock
- Solid tumor disease
- Hematological or marrow transplant
The Grrr-OH cohorts
- Acute Respiratory failure of the immunocompromised patient (INDIRA)
- The Carttas study