---
title: Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications
nct_id: NCT02186951
overall_status: COMPLETED
phase: PHASE3
sponsor: University Hospital, Limoges
study_type: INTERVENTIONAL
primary_condition: Ventilator-associated Pneumonia
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02186951.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02186951"
ct_last_update_post_date: 2020-03-18
last_seen_at: "2026-05-12T07:09:12.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Antibiotherapy During Therapeutic Hypothermia to Prevent Infectious Complications

**Official Title:** Prevention of Early Ventilator-associated Pneumonia With Antibiotic Therapy in Patients Treated With Mild Therapeutic Hypothermia After Cardiac Arrest.

**NCT ID:** [NCT02186951](https://clinicaltrials.gov/study/NCT02186951)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 197
- **Lead Sponsor:** University Hospital, Limoges
- **Conditions:** Ventilator-associated Pneumonia, Cardiac Arrests With Shockable Rhythm, Mild Therapeutic Hypothermia, Preventive Antibiotics
- **Start Date:** 2014-08-18
- **Completion Date:** 2017-09-14
- **CT.gov Last Update:** 2020-03-18

## Brief 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.

## Detailed Description

Multicenter add-on randomized controlled double-blind trial assessing the efficacy of preventive antibiotics amoxicillin-clavulanic acid vs placebo to prevent occurrence of early VAP after out-of-hospital cardiac arrest receiving mild therapeutic hypothermia, in addition to usual VAP prevention measures.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Amoxicillin clavulanic acid** (EXPERIMENTAL) — Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.
- **Placebo** (PLACEBO_COMPARATOR) — Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.

## Interventions

- **Amoxicillin - clavulanic acid** (DRUG) — Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.
- **Placebo** (DRUG) — Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.

## Primary Outcomes

- **Incidence reduction of early VAP** _(time frame: 7 days)_ — Incidence reduction of early VAP with short term amoxicillin-clavulanic acid in patients treated with hypothermia after out-of-hospital cardiac arrest

## Secondary Outcomes

- **Mortality** _(time frame: 28 days)_
- **Early nosocomial infectious complications** _(time frame: 28 days)_

## Locations (16)

- CH Angouleme - Service de Réanimation, Angoulême, Saint Michel, France
- CH Argenteuil - Service de Réanimation, Argenteuil, France
- CH Brive La Gaillarde - Service de Réanimation, Brive-la-Gaillarde, France
- CHU Dijon - Serve de Réanimation, Dijon, France
- AP-HP - Hôpital pointcaré - Service de Réanimation, Garches, France
- CH du MANS, Le Mans, France
- CHU de Limoges - Service de réanimation polyvalente, Limoges, France
- CHU Nantes - Service de réanimation, Nantes, France
- CHU Orléans - service de Réanimation, Orléans, France
- AP-HP - Hôpital Lariboisière - Service de Réanimation, Paris, France
- AP-HP - Hôpital Cochin - Service de Réanimation, Paris, France
- AP-HP - Hôpital Européen Georges Pompidou - Service de Réanimation, Paris, France
- CH Périgueux, Périgueux, France
- CHU Strasbourg - service de Réanimation, Strasbourg, France
- CHU Tours - Service de Réanimation, Tours, France
- CH Versailles - service de Réanimation, Versailles, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.ch angouleme - service de réanimation|angoulême|saint michel|france` — added _(2026-05-12)_
- `locations.ch argenteuil - service de réanimation|argenteuil||france` — added _(2026-05-12)_
- `locations.ch brive la gaillarde - service de réanimation|brive-la-gaillarde||france` — added _(2026-05-12)_
- `locations.chu dijon - serve de réanimation|dijon||france` — added _(2026-05-12)_
- `locations.ap-hp - hôpital pointcaré - service de réanimation|garches||france` — added _(2026-05-12)_
- `locations.ch du mans|le mans||france` — added _(2026-05-12)_
- `locations.chu de limoges - service de réanimation polyvalente|limoges||france` — added _(2026-05-12)_
- `locations.chu nantes - service de réanimation|nantes||france` — added _(2026-05-12)_
- `locations.chu orléans - service de réanimation|orléans||france` — added _(2026-05-12)_
- `locations.ap-hp - hôpital lariboisière - service de réanimation|paris||france` — added _(2026-05-12)_
- `locations.ap-hp - hôpital cochin - service de réanimation|paris||france` — added _(2026-05-12)_
- `locations.ap-hp - hôpital européen georges pompidou - service de réanimation|paris||france` — added _(2026-05-12)_
- `locations.ch périgueux|périgueux||france` — added _(2026-05-12)_
- `locations.chu strasbourg - service de réanimation|strasbourg||france` — added _(2026-05-12)_
- `locations.chu tours - service de réanimation|tours||france` — added _(2026-05-12)_
- `locations.ch versailles - service de réanimation|versailles||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02186951.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02186951*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*