Antimicrobial Treatment in Patients With Ventilator-associated Tracheobronchitis

NCT03012360 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2025-12-11

No results posted yet for this study

Summary

Antimicrobial treatment could be beneficial in patients with ventilator-associated tracheobronchitis (VAT). The hypothesis of this study is that antibiotic treatment for VAT (3 or 7 days), compared with no antibiotic treatment, would reduce the incidence of transition from VAT to ventilator-associated pneumonia (VAP).

Conditions

  • Mechanical Ventilation Complication
  • Critical Illness

Interventions

DRUG

ceftriaxone

2 g iv every 24h

DRUG

ciprofloxacin

400 mg iv every 8h

DRUG

imipenem

1 g iv every 8h

DRUG

linezolid

600 mg iv every 12h

DRUG

placebo

The SSI 0.9% or dextrose 5% used are based on routine procedure in different participating centers.Placebo will be prepared using IV bags, with the same of quantity as IMP

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV
  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Saad NSEIR, MD, PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-08
Primary Completion
2024-07-07
Completion
2024-07-07

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03012360 on ClinicalTrials.gov