CompletedPhase 3

Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications

France197 participantsStarted 2014-08-18

Plain-language summary

Mild therapeutic hypothermia is currently recommended in management of cardiac arrests with shockable rhythm. In mechanically ventilated patients who were resuscitated after out-of-hospital cardiac arrests, mild therapeutic hypothermia side effects are conductive for infectious complications and especially for ventilator-associated pneumonia (VAP). Despite high incidence of VAP and other infectious complications, it is not currently recommended to use antibiotic prophylaxis on the responsible germs. Yet VAP incidence could be decreased if an antibiotic therapy was systematically given to patient treated with mild therapeutic hypothermia after a cardiac arrest. Several retrospective studies showed less infectious complications but also decreased morbidity and mortality related to these complications when antibiotic therapy was given early to patients treated with therapeutic hypothermia after cardiac arrest.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Older than 18 years-old, intubated and mechanically ventilated after out-of-hospital resuscitated cardiac arrest secondary to shockable rhythm * Hospitalized in an ICU * Mild therapeutic hypothermia procedure (32° to 35°C) scheduled (24 to 36 hours) * Delay from ROSC to randomisation \< 6 hours * Consent from family members or emergency consent Exclusion Criteria: * Pregnancy * Out-of-hospital cardiac arrest secondary to non shockable rhythm and 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 * Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients. * History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam). * History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid, according to the latest version of the SmPC. * Previous lung disease * Predictable decision of early care limitation * Patient under guardianship or curatorship * Moribund patient * Participation to another trial within 30 days

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence reduction of early VAP

Timeframe: 7 days

Trial details

NCT IDNCT02186951

SponsorUniversity Hospital, Limoges

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-10-27

View on ClinicalTrials.gov More Ventilator-associated Pneumonia trials