TuberculosisNCT01167647
The Role of Routine Bacterial Culture Including Tuberculosis During Bronchoscopy: A Prospective Study
An observational study of Tuberculosis, run by Meir Medical Center at 2 sites in Israel.
Trial summary
Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when infections including tuberculosis (TB) are not strongly suspected. However, the value of this practice has been poorly defined. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- How many people
- 300 participants
- Where
- 2 sitesIsrael
- Study dates
- Jul 2010to Oct 2012
- Phase
- Observational
- 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
Study population: All patients who will undergo a bronchoscopy examination at pulmonary department in Meir Medical Center and will sign on informed consent.
Who may be able to join
- patients who will undergo a bronchoscopy examination at pulmonary department in Meir Medical Center
- patients who will sign on informed consent. -
Who cannot join
- 1)age under 18 years
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Pulmonary department, Meir Medical Center
Kfar Saba, Israel, 49100
Pulmonary department, Meir Medical Center
Kfar Saba, 49100
About this study
Official title: The Role of Routine Bacterial Culture Including Tuberculosis During
Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when infections including tuberculosis (TB) are not strongly suspected. However, the value of this practice has been poorly defined.
Read the detailed description
Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when infections including tuberculosis (TB) are not strongly suspected. However, the value of this practice has been poorly defined. Unnecessary bronchial cultures of bacteria may lead to over treatment in patients without clinical evidence of infections and may increase the drug resistant strains.
In areas with a high prevalence of TB, routine bronchial cultures may detect clinically unsuspected TB in an appreciable proportion of cases. However, in population with a low prevalence of TB, routine culture of bronchial aspirates may incur an unnecessary expanse and may lead to over diagnosis and over treatment of patients with non pathogenic atypical mycobacteria detected by acid-fast bacillus strains.
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, culture, bronchoscopy
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| bronchoscopy patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of positive tuberculosis culture
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2012
- Study completionOct 2012
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 TuberculosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Shitrit, MD, Principal investigator, Meir Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01167647
- Sponsor's protocol ID
- MMC10-087-10.CTIL
- Status last verified
- Mar 2012
- First submitted
- 21 Jul 2010
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Talker O, Matveychuk A, Guber A, Mandelbaum-Livnat MM, Varsano S, Shitrit D. Is routine bronchoscopic culture indicated in areas with low tuberculosis prevalence? Int J Tuberc Lung Dis. 2013 Aug;17(8):1100-3. doi: 10.5588/ijtld.12.0997.
PubMed 23827036
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Routine Bacterial Culture Including Tuberculosis During
- ClinicalTrials.gov ID
- NCT01167647
- Acronym / sponsor ID
- MMC10-087-10.CTIL
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, culture, bronchoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Jul 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.
Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when infections including tuberculosis (TB) are not strongly suspected. However, the value of this practice has been poorly defined.
Detailed description
Many centers routinely culture bronchoscopy samples for bacteria and mycobacteria even when infections including tuberculosis (TB) are not strongly suspected. However, the value of this practice has been poorly defined. Unnecessary bronchial cultures of bacteria may lead to over treatment in patients without clinical evidence of infections and may increase the drug resistant strains.
In areas with a high prevalence of TB, routine bronchial cultures may detect clinically unsuspected TB in an appreciable proportion of cases. However, in population with a low prevalence of TB, routine culture of bronchial aspirates may incur an unnecessary expanse and may lead to over diagnosis and over treatment of patients with non pathogenic atypical mycobacteria detected by acid-fast bacillus strains.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bronchoscopy patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who will undergo a bronchoscopy examination at pulmonary department in Meir Medical Center and will sign on informed consent.
Key inclusion criteria (2 listed)
- patients who will undergo a bronchoscopy examination at pulmonary department in Meir Medical Center
- patients who will sign on informed consent. -
Key exclusion criteria (1 listed)
- 1)age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of positive tuberculosis culture
Time frame: 12 months
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 6 Mar 2013.
- Derived from this study: PubMed 23827036Talker O, Matveychuk A, Guber A, Mandelbaum-Livnat MM, Varsano S, Shitrit D. Is routine bronchoscopic culture indicated in areas with low tuberculosis prevalence? Int J Tuberc Lung Dis. 2013 Aug;17(8):1100-3. doi: 10.5588/ijtld.12.0997.
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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.
David Shitrit, MD principal investigator
Meir Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Meir Medical Center at 2 sites in Israel.
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 2 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 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
number of positive tuberculosis culture (time frame: 12 months). 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 NCT01167647, 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 6 Mar 2013.