Respiratory Tract DiseasesNCT00122057
Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis
A study testing antibiotic treatment in people with Respiratory Tract Diseases and Nosocomial Infections, run by University Hospital, Lille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Diseases, Nosocomial Infections
- What is being tested?
- antibiotic treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2005to Jun 2007
- Phase
- Interventional
- 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
Who may be able to join
- Patients with tracheobronchitis diagnosed after 48h of invasive mechanical ventilation
Who cannot join
- Immunodepressed patients
- Patients with tracheostomy at ICU admission
- Patients who developed ventilator-associated pneumonia before ventilator-associated tracheobronchitis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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 (α = 0.025, β = 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.
- Conditions
- Respiratory Tract Diseases, Nosocomial Infections
- Being tested
- antibiotic treatment
- Keywords
- ventilator-associated tracheobronchitis, nosocomial tracheobronchitis
- Medical subject headings
- Respiratory Tract Diseases, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic treatmentDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of mechanical ventilation
Secondary outcomes (3)
length of intensive care unit (ICU) stay
mortality rate
ventilator-associated pneumonia rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJun 2005
- Primary completionMay 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory Tract DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Investigators
- Saad Nseir, MD, Principal investigator, University Hospital of Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122057
- Sponsor's protocol ID
- 2005/0506
- Status last verified
- Sep 2006
- First submitted
- 14 Jul 2005
- Last updated
- 1 Jun 2011
- Results posted
- No
Publications
Nseir S, Favory R, Jozefowicz E, Decamps F, Dewavrin F, Brunin G, Di Pompeo C, Mathieu D, Durocher A; VAT Study Group. Antimicrobial treatment for ventilator-associated tracheobronchitis: a randomized, controlled, multicenter study. Crit Care. 2008;12(3):R62. doi: 10.1186/cc6890. Epub 2008 May 2.
PubMed 18454864
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Antibiotic Treatment on Outcome in Patients With Ventilator-Associated Tracheobronchitis
- ClinicalTrials.gov ID
- NCT00122057
- Acronym / sponsor ID
- 2005/0506
- Conditions
- Respiratory Tract Diseases, Nosocomial Infections
- Keywords
- ventilator-associated tracheobronchitis, nosocomial tracheobronchitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- May 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 21 Jul 2005 (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.
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.
Detailed description
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 (α = 0.025, β = 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with tracheobronchitis diagnosed after 48h of invasive mechanical ventilation
Key exclusion criteria (3 listed)
- Immunodepressed patients
- Patients with tracheostomy at ICU admission
- Patients who developed ventilator-associated pneumonia before ventilator-associated tracheobronchitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antibiotic treatment | Drug | – |
Primary outcome
duration of mechanical ventilation
3 secondary outcomes
length of intensive care unit (ICU) stay
mortality rate
ventilator-associated pneumonia rate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
- Derived from this study: PubMed 18454864Nseir S, Favory R, Jozefowicz E, Decamps F, Dewavrin F, Brunin G, Di Pompeo C, Mathieu D, Durocher A; VAT Study Group. Antimicrobial treatment for ventilator-associated tracheobronchitis: a randomized, controlled, multicenter study. Crit Care. 2008;12(3):R62. doi: 10.1186/cc6890. Epub 2008 May 2.
Related trials for Respiratory Tract Diseases
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Saad Nseir, MD principal investigator
University Hospital of Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antibiotic treatment in people with Respiratory Tract Diseases and Nosocomial Infections, run by University Hospital, Lille 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 1 Jun 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of mechanical ventilation. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00122057, which also lists 1 linked publication.
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 1 Jun 2011.