Ventilator-associated PneumoniaTARGET-REANCT02127528
Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care
An observational study of Ventilator-associated Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
this study aims to verify the adequacy of doses of antibiotics prescribed in clinical practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventilator-associated Pneumonia
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pneumonia acquired in mechanically ventilated patients (PAVM)
Who may be able to join
- Use of mechanical ventilation for more than 48 hours
- Clinical suspicion of ventilation-acquired pneumonia (VAP) defined by new radiological persisting infiltrate (or ARDS) AND one of the following features:
- purulent tracheal aspirates OR temperature ≥ 38.3°C OR leukocytosis> 10 giga/L
- High risk of multidrug-resistant bacteria, defined as either at least 6 days of mechanical ventilation OR antibiotic treatment in the previous 15 days
- Implementation of a prior distal respiratory sample for microbiological diagnosis by bronchoalveolar lavage (BAL) OR distal sampling by protected catheter (PDP)
- Age ≥ 18 years
- Implementing a medical examination
- Obtain the written consent of the patient, one of its relatives or trusted person previously designated or emergency clause.
Who cannot join
- Pregnant woman
- Expected death within 72 hours of diagnosis of VAP patient
- Dialysis
- No affiliation to a social security scheme (beneficiary or legal)
- Contraindication to one of classes of molecules used antibiotics (β-lactam / Fluoroquinolones / Aminoglycosides), contained in the Summary of Product Characteristics for authorization on the market.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CH Victor Dupouy
Argenteuil, Val d'Oise, 95100
Olivier Pajot, MD, +33 1 34 23 24 15, olivier.pajot@ch-argenteuil.fr
Olivier Pajot, MD
About this study
Official title: Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care: Pharmacodynamic Evaluation and Impact.
this study aims to verify the adequacy of doses of antibiotics prescribed in clinical practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. The impact of these pharmacodynamic parameters on the clinical and microbiological VAP will be evaluated.
- Conditions
- Ventilator-associated Pneumonia
- Medical subject headings
- Pneumonia, Ventilator-Associated
What is being measured
The primary outcome is the main question the study is designed to answer.
adequate antibiotics
proportion of patients for whom the pharmacodynamic target defined a priori according to data from the literature is reached for each antibiotic anti Gram-negative bacillus used empirically activity (including β-lactams, fluoroquinolones and aminoglycosides)
Measured: 28 days
Secondary outcomes (7)
Bacterial species
Bacterial species in question, defined as any bacteria isolated in significant amounts on the diagnostic breath sampling
Measured: 28 days
Distribution of the main pharmacodynamic parameters
- ratio of the peak serum level (Cmax) on the minimal inhibitory concentration (MIC), ie Cmax/MIC ratio (for aminoglycosides and fluoroquinolones): distribution in the population and proportion of patients with Cmax/MIC> 10
- ratio of the Area Under the serum concentration time Curve (AUC) on the MIC, ie AUC/MIC ratio (for fluoroquinolones) : distribution in the population and proportion of patients with an AUC/MIC ratio> 125
- percentage of time spent above the MIC between 2 injections, and trough/MIC ratio (for β-lactams): distribution in the population and proportion of patients with a T>MIC of 100% (intermittent infusion) or trough/MIC> 4 (continuous infusion)
Measured: 28 days
Eradication of gram negative bacilli responsible for VAP
defined as a bacterial count from distal respiratory sample realized during the third day of treatment, less than the threshold for each isolated Gram negative bacilli initially beyond these thresholds
Measured: 28 days
Death
Measured: 28 days
Number of days alive without mechanical ventilation
Measured: 28 days
Clinical recovery
defined as patient alive with Clinical Pulmonary Infection Score (CPIS) <8
Measured: 28 days
Score of organ failure (SOFA)
repeated measures every 48h for 8 days
Measured: 8 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventilator-associated PneumoniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127528
- Sponsor's protocol ID
- P1101137
- Acronym
- TARGET-REA
- Status last verified
- Apr 2016
- First submitted
- 7 Nov 2013
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empiric Antibiotic Therapy for Ventilator-acquired Pneumonia With Gram-negative Bacilli in Intensive Care: Pharmacodynamic Evaluation and Impact.
- ClinicalTrials.gov ID
- NCT02127528
- Acronym / sponsor ID
- TARGET-REA / P1101137
- Conditions
- Ventilator-associated Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study aims to verify the adequacy of doses of antibiotics prescribed in clinical practice for the treatment of ventilated acquired pneumonia (VAP) in the intensive care unit (ICU) with the pharmacodynamic efficacy criteria considered relevant literature. The impact of these pharmacodynamic parameters on the clinical and microbiological VAP will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pneumonia acquired in mechanically ventilated patients (PAVM)
Key inclusion criteria (8 listed)
- Use of mechanical ventilation for more than 48 hours
- Clinical suspicion of ventilation-acquired pneumonia (VAP) defined by new radiological persisting infiltrate (or ARDS) AND one of the following features:
- purulent tracheal aspirates OR temperature ≥ 38.3°C OR leukocytosis> 10 giga/L
- High risk of multidrug-resistant bacteria, defined as either at least 6 days of mechanical ventilation OR antibiotic treatment in the previous 15 days
- Implementation of a prior distal respiratory sample for microbiological diagnosis by bronchoalveolar lavage (BAL) OR distal sampling by protected catheter (PDP)
Key exclusion criteria (5 listed)
- Pregnant woman
- Expected death within 72 hours of diagnosis of VAP patient
- Dialysis
- No affiliation to a social security scheme (beneficiary or legal)
- Contraindication to one of classes of molecules used antibiotics (β-lactam / Fluoroquinolones / Aminoglycosides), contained in the Summary of Product Characteristics for authorization on the market.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
adequate antibiotics
Time frame: 28 days
proportion of patients for whom the pharmacodynamic target defined a priori according to data from the literature is reached for each antibiotic anti Gram-negative bacillus used empirically activity (including β-lactams, fluoroquinolones and aminoglycosides)
7 secondary outcomes
Bacterial species
Time frame: 28 days
Distribution of the main pharmacodynamic parameters
Time frame: 28 days
Eradication of gram negative bacilli responsible for VAP
Time frame: 28 days
Death
Time frame: 28 days
Number of days alive without mechanical ventilation
Time frame: 28 days
Clinical recovery
Time frame: 28 days
Score of organ failure (SOFA)
Time frame: 8 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventilator-associated Pneumonia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier Pajot, MD (+33 1 34 23 24 51, olivier.pajot@ch-argenteuil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adequate antibiotics (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.