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Trial record 37 of 753 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Early Stop(Ruling) of the Antibiotic Treatment During Pneumopathies d' Inhalation (APAPI)

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ClinicalTrials.gov Identifier: NCT03763799
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Brief Summary:

The two most common consequences resulting from aspiration are chemical pneumonitis and bacterial aspiration pneumonia. Both entities present with comparable clinical signs and symptoms. In the absence of a reliable clinical or biological marker to differentiate between these two conditions, most patients with suspected aspiration are treated empirically with antibiotics. De-escalation of initial antibiotic treatment is encouraged based on the results of microbiological results, usually performed before starting antimicrobial treatment. However, in most hospitals, 48-72h are required to obtain the results of microbiological cultures, and to de-escalate empirical large spectrum antibiotic treatment.

The use of the Unyvero®, a multiplex PCR-based testing system, for detection of respiratory bacterial pathogens would allow decreasing the percentage of patients with aspiration syndrome who will receive unappropriated antibiotic treatment at Day 3.


Condition or disease Intervention/treatment Phase
Aspiration Pneumonia Procedure: PCR-based microbiological diagnosis strategy Procedure: Standard microbiological diagnosis strategy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Impact of a Strategy Based on the Unyvero® Testing System on Appropriate Antimicrobial Treatment in Patients With Suspected Aspiration Pneumonia Requiring Mechanical Ventilation : a Randomized Controlled Unblinded Trial
Estimated Study Start Date : December 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: multiplex PCR strategy Procedure: PCR-based microbiological diagnosis strategy
Unyvero®, a multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation

Active Comparator: standard strategy Procedure: Standard microbiological diagnosis strategy
Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation




Primary Outcome Measures :
  1. The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment [ Time Frame: 72 hours after antibiotic treatment initiation ]

Secondary Outcome Measures :
  1. the percentage of patients who will receive appropriate antibiotic treatment. [ Time Frame: at Day 28 and Day 90 after antibiotic treatment initiation ]
  2. the percentage of patients who will receive targeted antibiotic treatment. [ Time Frame: at Day 28 and Day 90 after antibiotic treatment initiation ]
  3. mechanical ventilation free days. [ Time Frame: at Day 28 and Day 90 after antibiotic treatment initiation ]
  4. length of ICU stay. [ Time Frame: up to Day 90 ]
  5. ICU mortality. [ Time Frame: up to Day 90 ]
  6. antibiotic free days. [ Time Frame: up to Day 90 ]
  7. percentage of patients with colonization or infection related to multidrug-resistant bacteria (MDR) [ Time Frame: at Day 28 and Day 90 after antibiotic treatment initiation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of risk factors for aspiration :
  • known or likely swallowing dysfunction,
  • altered consciousness,
  • cardiac arrest,
  • difficult intubation
  • witnessed aspiration
  • symptoms and signs suggestive of lower respiratory tract pathology
  • temperature ≥38.5°C or <36°C
  • leukocyte count ≥10 000/µL or <1500/µL
  • purulent sputum or tracheal aspirate.
  • new radiographic infiltrate on chest X-ray
  • tracheal intubation and mechanical ventilation since less than 48 hours

Exclusion Criteria:

  • pregnant women
  • refuse to participate to the study
  • no informed consent
  • documented bacteremia
  • septic shock
  • severe immunosuppression: leukocytes<1000/L or neutrophils<500/L, chemotherapy during the last 3 months, organ transplant with chronic immunosuppressors use, HIV (CD4<50), and chronic corticosteroid use (>0.5 mg/kg day for at least one month during the last three months).
  • moribund patients (SAPS II >90).

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03763799     History of Changes
Other Study ID Numbers: 2018_40
2018-A02219-46 ( Other Identifier: ID-RCB number, ANSM )
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Aspiration pneumonia
Invasive ventilation
PCR
Antibiotics
Tracheal aspirate
Additional relevant MeSH terms:
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Pneumonia
Pneumonia, Aspiration
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Anti-Bacterial Agents
Anti-Infective Agents