ANtibiotherapy during Therapeutic HypothermiA to pRevenT Infectious Complications.
- Conditions
- PneumoniaMedDRA version: 18.0Level: LLTClassification code 10047263Term: Ventilation pneumonitisSystem Organ Class: 100000004855Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-000202-35-FR
- Lead Sponsor
- CHU de LIMOGES
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 194
-Patients older than 18 years-old, mechanically ventilated after an out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm
-Hospitalized in an ICU
-Mild therapeutic hypothermia procedure scheduled (24 to 36 hours) before randomization
-Delay from ROSC to randomisation < 6 hours
-Consent from family members or emergency consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 92
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100
-Pregnant women
-Out-of-hospital cardiac arrest secondary to non shockable rhythm (mild therapeutic hypothermia not yet evidence based”)
-In-hospital cardiac arrest
-Need for cardiac support by cardiopulmonary bypass
-Ongoing antibiotic therapy or during the week before
-Ongoing or concomitant pneumonia
-Known chronic colonization with MRB
-Known severe allergy to beta-lactame antibiotics (Quincke edema, shock) and amoxicillin-clavulanic acid use contraindications
-Previous lung disease making radiological interpretation difficult for VAP diagnosis
-Predictable decision of early care limitation or withdrawal (< 7 days)
-Moribund patient
-Participation in any other clinical study that involves the administration of medication at the time of randomization or during the 30 days prior to study start or which can influence primary outcome
- Patient under guardianship or curatorship
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Incidence reduction of early VAP with short term amoxicillin-clavulanic acid in patients treated with hypothermia after out-of-hospital cardiac arrest;Secondary Objective: Impact on :<br>*Early nosocomial infectious complications <br>*Incidence and epidemiology of late VAP<br>*Mortality<br>*Antibiotics consumption <br>*Intestinal microbiota <br>*Ventilator free days<br>*Safety<br>*Cost of each strategy<br>*Biomarkers sub-study<br>;Primary end point(s): Onset of an early VAP (during 7 first days of hospitalization). <br>As VAP definition remains controversial and difficult (overlap between colonization, VAT and VAP) with different approaches, some using scoring and others microbiological quantitative thresholds, sites will be asked to document all VAP or suspected VAP episode and use routine site diagnosis tools to treat patients.<br>;Timepoint(s) of evaluation of this end point: 7 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): -Nosocomial infectious complications not related to VAP<br>-Late VAP (analysed by the independent blind adjudication committee) <br>-Mortality at D28 and cause of death (neurological or extra-neurological)<br>-Intestinal carriage of MRB at D7 which were not present at D0<br>-Antibiotics consumption in ICU, expressed as the number of days with antibiotics<br>-Length of stay in the ICU<br>-Ventilator-free days at D28. This outcome will be assessed applying the following rules:<br>oThe period of interest will begin at the randomization date<br>oPatients who die before day 28 will be affected a 0 value<br>oDays between two mechanical ventilation episode will be taken into account<br>oA successful extubation will be defined as a spontaneous breathing 48h after extubation<br>;Timepoint(s) of evaluation of this end point: 28 days