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OpenTrials
Completed

NCT Number: NCT03763799

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Amiens Picardie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PCR-based microbiological diagnosis strategy

Procedure

A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation

Standard microbiological diagnosis strategy

Procedure

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

Primary outcomes

  1. The percentage of patients who will benefit from an early stop of the probabilist antibiotic treatment

    Time frame: 48 hours after antibiotic treatment initiation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: APAPI

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2018
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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