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Impact of Antibiotic Treatment On Outcome in Patients with Ventilator-Associated Tracheobronchitis - Article


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Respiratory Diseases

Lung Diseases; Pleurisy 




Clinical Trial: Impact of Antibiotic Treatment On Outcome in Patients with Ventilator-Associated Tracheobronchitis

This study is currently recruiting patients.

Sponsored by: University Hospital, Lille
Information provided by: University Hospital, Lille

Purpose

The aim of this study is to determine whether antibiotic treatment could reduce mechanical ventilation duration in patients with nosocomial tracheobronchitis acquired under mechanical ventilation.
Condition Intervention
Respiratory Tract Diseases
Nosocomial Infections
 Drug: antibiotic treatment

MedlinePlus related topics:  Respiratory Diseases

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Further Study Details: 
Primary Outcomes: duration of mechanical ventilation
Secondary Outcomes: length of intensive care unit (ICU) stay; mortality rate; ventilator-associated pneumonia rate
Expected Total Enrollment:  390

Study start: June 2005;  Expected completion: December 2008
Last follow-up: June 2008;  Data entry closure: June 2008

Rationale: Ventilator-associated tracheobronchitis (VAT) is common in intensive care unit (ICU) patients, rates of 2.7%-10.6% are reported in the literature. This nosocomial infection is associated with weaning difficulties resulting in prolonged duration of mechanical ventilation (MV) and ICU stay. A case-control study performed in chronic obstructive pulmonary disease (COPD) patients with VAT found antibiotic treatment to be significantly associated with reduced duration of MV. Another case control-study, performed in VAT patients without chronic respiratory failure, found no significant difference in duration of MV between patients who received adequate antibiotic treatment and those who received inadequate antibiotic treatment. In addition, antibiotic use is known to be associated with subsequent multidrug-resistant bacteria (MRB), longer duration of MV, and mortality rates. Therefore, a randomized controlled study is necessary to determine the impact of antibiotic treatment on outcome in VAT patients.

Patients and methods: 390 patients will be included in this prospective randomized open multicenter study. Inclusion of 390 patients is required to demonstrate a significant reduction of MV duration of 5 days ( = 0.025,  = 0.10). An intermediate analysis will be performed. All patients intubated and ventilated > 48h who developed a first episode of VAT are eligible. Primary endpoint is the duration of MV. Secondary end points are ICU length of stay, mortality, ventilator-associated pneumonia, ICU-acquired infection, MRB, and yeast rates.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Patients with tracheobronchitis diagnosed after 48h of invasive mechanical ventilation

Exclusion Criteria:

  • Immunodepressed patients
  • Patients with tracheostomy at ICU admission
  • Patients who developed ventilator-associated pneumonia before ventilator-associated tracheobronchitis

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00122057

Saad Nseir, MD      (33) 320444495    s-nseir@chru-lille.fr

France
      12 ICUs in north of France, Lille,  France; Recruiting
Saad Nseir, MD

Study chairs or principal investigators

Saad Nseir, MD,  Principal Investigator,  University Hospital of Lille   

More Information

Study ID Numbers:  2005/0506
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00122057
Health Authority: France: Ministry of Health
ClinicalTrials.gov processed this record on 2005-07-26

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December 6, 2009



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