Hospital-acquired PneumoniaNCT01266863
E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.
A study testing E test method in people with Hospital-acquired Pneumonia, run by Université Victor Segalen Bordeaux 2 at 1 site in France.
Trial summary
To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital-acquired Pneumonia
- What is being tested?
- E test method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Dec 2013
- 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
- all patients with suspected HAP undergoing BAL will be eligible
Who cannot join
- contraindications for BAL (PaO2/FIO2 <100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria <104 CFU/ml.
Trial locations and contacts
1 site in 1 country.
About this study
To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with the aim of validating a new method increasing the rapidity of antibiogram analysis compared to standard methods of culture. This antibiogram will be provided by E test strips directly applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour after its completion. The occurrence of major errors (S with E test method, I or R with standard method) and minor errors (I or R with E test method and S with standard method)will be observed and a comparison of H6, H10 and H24 results performed.
- Conditions
- Hospital-acquired Pneumonia
- Being tested
- E test method
- Keywords
- Hospital-acquired pneumonia, E test, Antibiogram, Bronchoalveolar lavage
- Medical subject headings
- Healthcare-Associated Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E test methodOther
E test strips directly applied to BAL
| Study group | Role | What they receive |
|---|---|---|
| E test method | Experimental | Not described Receives: Other: E test method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major error defined as the MIC(s) classified as R or I by E test method and S by referent method
Measured: 2 days
Secondary outcomes (1)
Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2013
- Study completionDec 2013
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 Hospital-acquired PneumoniaStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Victor Segalen Bordeaux 2
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexandre Boyer, Université Victor Segalen Bordeaux 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266863
- Sponsor's protocol ID
- ABoyer3
- Status last verified
- Jun 2015
- First submitted
- 22 Dec 2010
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Boyer A, Goret J, Clouzeau B, Romen A, Prevel R, Lhomme E, Vargas F, Hilbert G, Bebear C, Gruson D, M'Zali F. Tailoring Empirical Antimicrobial Therapy in Subjects With Ventilator-Associated Pneumonia With a 10-Hour E-Test Approach. Respir Care. 2019 Mar;64(3):307-312. doi: 10.4187/respcare.06255. Epub 2018 Dec 11.
PubMed 30538161
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E Test Strips Applied to Bronchoalveolar Lavage for Suspicion of Hospital-acquired Pneumonia to Accelerate Antibiogram Analysis.
- ClinicalTrials.gov ID
- NCT01266863
- Acronym / sponsor ID
- ABoyer3
- Conditions
- Hospital-acquired Pneumonia
- Keywords
- Hospital-acquired pneumonia, E test, Antibiogram, Bronchoalveolar lavage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Université Victor Segalen Bordeaux 2University, hospital or other
- Study start
- Sep 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Dec 2010 (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.
To rapidly adapt or deescalate the initially broad antibiotic treatment, an antibiogram analysis is required. E test strips have successfully provided an antibiogram 24 h after having been directly applied to bronchoalveolar lavage (BAL). An open-label, prospective cohort study of consecutive patients with hospital-acquired pneumonia will be conducted with the aim of validating a new method increasing the rapidity of antibiogram analysis compared to standard methods of culture. This antibiogram will be provided by E test strips directly applied to bronchoalveolar lavage (BAL) samples and analyzed from the 6th up to the 24th hour after its completion. The occurrence of major errors (S with E test method, I or R with standard method) and minor errors (I or R with E test method and S with standard method)will be observed and a comparison of H6, H10 and H24 results performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E test method | Experimental | Other: E test method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients with suspected HAP undergoing BAL will be eligible
Key exclusion criteria (1 listed)
- contraindications for BAL (PaO2/FIO2 <100, risk of bronchoscopy-related haemorrhagic complications), secondary exclusion of patients with negative cultures, defined by a threshold of bacteria <104 CFU/ml.
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 |
|---|---|---|
| E test methodE test strips directly applied to BAL | Other | E test method |
Primary outcome
Major error defined as the MIC(s) classified as R or I by E test method and S by referent method
Time frame: 2 days
1 secondary outcome
Minor error defined as the MIC(s) classified as R or I by E test method and S by referent method
Time frame: 2 days
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 10 Jun 2015.
- Derived from this study: PubMed 30538161Boyer A, Goret J, Clouzeau B, Romen A, Prevel R, Lhomme E, Vargas F, Hilbert G, Bebear C, Gruson D, M'Zali F. Tailoring Empirical Antimicrobial Therapy in Subjects With Ventilator-Associated Pneumonia With a 10-Hour E-Test Approach. Respir Care. 2019 Mar;64(3):307-312. doi: 10.4187/respcare.06255. Epub 2018 Dec 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E test method in people with Hospital-acquired Pneumonia, run by Université Victor Segalen Bordeaux 2 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 1 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 10 Jun 2015. 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?
Major error defined as the MIC(s) classified as R or I by E test method and S by referent method (time frame: 2 days). 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 NCT01266863, 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 10 Jun 2015.