Tuberculosis, PulmonaryNCT03732014
Bronchial Washings in Sputum Scarce Cases of Pulmonary Tuberculosis
An observational study of Tuberculosis, Pulmonary, run by Faisal Faiyaz Zuberi at 1 site in Pakistan.
Trial summary
This study will be conducted in Ojha Institute of Chest Diseases and Department of Medicine, Dow Medical College, Karachi both affiliated with Dow University of Health Sciences, Karachi, Pakistan after IRB approval. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Tuberculosis, Pulmonary
- How many people
- 0 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Jan 2019to 30 Nov 2019
- 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 12 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sputum-scarce suspected pulmonary TB
Who may be able to join
- Suspicion of Pulmonary TB on history, examination and CXR
- Unable to produce sputum
Who cannot join
- extra pulmonary tuberculosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Xpert MTB/RIF, Microscopy and AFB Culture in Bronchial Washings in Sputum Scarce Cases of Suspected Pulmonary Tuberculosis
This study will be conducted in Ojha Institute of Chest Diseases and Department of Medicine, Dow Medical College, Karachi both affiliated with Dow University of Health Sciences, Karachi, Pakistan after IRB approval. All patients of either gender with clinical suspicion of PTB on history, examination and CXR and not expectorating sputum or less than 1 ml will be included in the study. Patients with extra pulmonary tuberculosis, those with age < 12 years will be excluded. Demographic data of selected patients including age, gender, contact with PTB patient will be collected. Data will be entered in study proforma.
Selected patients will undergo bronchoscopy using Olympus 180 series video bronchoscope. Bronchial Wash will be done and 3 aliquots of BW samples will be collected by suctioning. One part of washing will be immediately inoculated in AFB Culture media and second will be submitted for Xpert MTB/RIF testing. Third part will be centrifuged, and sediment will be subjected to AFB microscopy after staining with Ziehl-Neelsen technique.
Read more
Results of microscopy and Xpert MTB/RIF will be collected next day, and treatment will be started if MTB comes positive, while results of AFB Culture will be collected after 6 weeks and treatment will be started if not already started on previous reports. Sensitivity/Resistance pattern will be recorded for both Xpert MTB/RIF and ABF Culture.
The sample size of 72 was taken for conduct of study. Sample size calculations were done using PASS software version 15.0. Frequency of positive tests will be calculated. Mean age will be calculated according to gender and compared by Student's t-test. Sensitivity \& specificity of tests will be calculated using online calculator by VassarStats. Frequency of positive yield of Xpert MTB/RIF will be compared to that of microscopy by χ2- test. P-value of <0.05 was considered significant.
Read the detailed description
This cross-sectional study will be conducted in Ojha Institute of Chest Diseases and Department of Medicine, Dow Medical College, Karachi both affiliated with Dow University of Health Sciences, Karachi, Pakistan after IRB approval. Patients were informed of study protocol, benefits and risks and written consent will be taken. All patients of either gender with clinical suspicion of PTB on history, examination and CXR and not expectorating sputum or less than 1 ml will be included in the study. Patients with extra pulmonary tuberculosis, those with age < 12 years will be excluded. Demographic data of selected patients including age, gender, contact with PTB patient will be collected. Data will be entered in study proforma.
Selected patients will undergo bronchoscopy using Olympus 180 series video bronchoscope. BW will be done by instilling 60 ml of normal saline via bronchoscope and 3 aliquots of BW samples will be collected by suctioning. One part of washing will be immediately inoculated in AFB Culture media and second will be submitted for Xpert MTB/RIF testing. Third part will be centrifuged, and sediment will be subjected to AFB microscopy after staining with Ziehl-Neelsen technique.
Results of microscopy and Xpert MTB/RIF will be collected next day, and treatment will be started if MTB comes positive, while results of AFB Culture will be collected after 6 weeks and treatment will be started if not already started on previous reports. Sensitivity/Resistance pattern will be recorded for both Xpert MTB/RIF and ABF Culture.
Sample size was calculated using reported both for smear microscopy and Xpert MTB/RIF. Using the reported sensitivity of Xpert MTB/RIF of 82.4% by Rakotoarivelo R, et al and keeping the power at 95% and alpha at 0.05 the sample size for Xpert MTB/RIF is estimated as 25. For smear microscopy the reported sensitivity of 70.47% by Chowdhury R et al was used and sample size of 72 was calculated using same parameters as those for Xpert MTB/RIF. Higher sample size of 72 was taken for conduct of study. Sample size calculations were done using PASS software version 15.0. Frequency of positive tests will be calculated. Mean age will be calculated according to gender and compared by Student's t-test. Sensitivity \& specificity of tests will be calculated using online calculator by VassarStats. Frequency of positive yield of Xpert MTB/RIF will be compared to that of microscopy by χ2- test. P-value of <0.05 was considered significant.
- Conditions
- Tuberculosis, Pulmonary
- Keywords
- Bronchial wash, Xpert MTB/RIF, AFB Culture, AFB microscopy, Bronchoscopy
- Medical subject headings
- Tuberculosis, Pulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
AFB Positivity
AFB positivity on Xpert RIF/MTB, Culture \& Microscopy
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2018
- Study start2 Jan 2019
- Primary completion1 Sep 2019
- Study completion30 Nov 2019
Why it stopped: Funding could not be secured
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 Tuberculosis, PulmonaryStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faisal Faiyaz Zuberi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Faisal Faiyaz Zuberi, Dow University of Health Sciences
- Investigators
- Bader F Zuberi, FCPS, Study director, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03732014
- Sponsor's protocol ID
- BrWash
- Status last verified
- Aug 2021
- First submitted
- 4 Nov 2018
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rakotoarivelo R, Ambrosioni J, Rasolofo V, Raberahona M, Rakotosamimanana N, Andrianasolo R, Ramanampamonjy R, Tiaray M, Razafimahefa J, Rakotoson J, Randria M, Bonnet F, Calmy A; MadaXpert Study Group. Evaluation of the Xpert MTB/RIF assay for the diagnosis of smear-negative pulmonary and extrapulmonary tuberculosis in Madagascar. Int J Infect Dis. 2018 Apr;69:20-25. doi: 10.1016/j.ijid.2018.01.017. Epub 2018 Mar 1.
PubMed 29408360
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Xpert MTB/RIF, Microscopy and AFB Culture in Bronchial Washings in Sputum Scarce Cases of Suspected Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT03732014
- Acronym / sponsor ID
- BrWash
- Conditions
- Tuberculosis, Pulmonary
- Keywords
- Bronchial wash, Xpert MTB/RIF, AFB Culture, AFB microscopy, Bronchoscopy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funding could not be secured
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Faisal Faiyaz ZuberiUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 6 Nov 2018 (actual)
- 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.
This study will be conducted in Ojha Institute of Chest Diseases and Department of Medicine, Dow Medical College, Karachi both affiliated with Dow University of Health Sciences, Karachi, Pakistan after IRB approval. All patients of either gender with clinical suspicion of PTB on history, examination and CXR and not expectorating sputum or less than 1 ml will be included in the study. Patients with extra pulmonary tuberculosis, those with age < 12 years will be excluded. Demographic data of selected patients including age, gender, contact with PTB patient will be collected. Data will be entered in study proforma.
Selected patients will undergo bronchoscopy using Olympus 180 series video bronchoscope. Bronchial Wash will be done and 3 aliquots of BW samples will be collected by suctioning. One part of washing will be immediately inoculated in AFB Culture media and second will be submitted for Xpert MTB/RIF testing. Third part will be centrifuged, and sediment will be subjected to AFB microscopy after staining with Ziehl-Neelsen technique.
Results of microscopy and Xpert MTB/RIF will be collected next day, and treatment will be started if MTB comes positive, while results of AFB Culture will be collected after 6 weeks and treatment will be started if not already started on previous reports. Sensitivity/Resistance pattern will be recorded for both Xpert MTB/RIF and ABF Culture.
The sample size of 72 was taken for conduct of study. Sample size calculations were done using PASS software version 15.0. Frequency of positive tests will be calculated. Mean age will be calculated according to gender and compared by Student's t-test. Sensitivity \& specificity of tests will be calculated using online calculator by VassarStats. Frequency of positive yield of Xpert MTB/RIF will be compared to that of microscopy by χ2- test. P-value of <0.05 was considered significant.
Detailed description
This cross-sectional study will be conducted in Ojha Institute of Chest Diseases and Department of Medicine, Dow Medical College, Karachi both affiliated with Dow University of Health Sciences, Karachi, Pakistan after IRB approval. Patients were informed of study protocol, benefits and risks and written consent will be taken. All patients of either gender with clinical suspicion of PTB on history, examination and CXR and not expectorating sputum or less than 1 ml will be included in the study. Patients with extra pulmonary tuberculosis, those with age < 12 years will be excluded. Demographic data of selected patients including age, gender, contact with PTB patient will be collected. Data will be entered in study proforma.
Selected patients will undergo bronchoscopy using Olympus 180 series video bronchoscope. BW will be done by instilling 60 ml of normal saline via bronchoscope and 3 aliquots of BW samples will be collected by suctioning. One part of washing will be immediately inoculated in AFB Culture media and second will be submitted for Xpert MTB/RIF testing. Third part will be centrifuged, and sediment will be subjected to AFB microscopy after staining with Ziehl-Neelsen technique.
Results of microscopy and Xpert MTB/RIF will be collected next day, and treatment will be started if MTB comes positive, while results of AFB Culture will be collected after 6 weeks and treatment will be started if not already started on previous reports. Sensitivity/Resistance pattern will be recorded for both Xpert MTB/RIF and ABF Culture.
Sample size was calculated using reported both for smear microscopy and Xpert MTB/RIF. Using the reported sensitivity of Xpert MTB/RIF of 82.4% by Rakotoarivelo R, et al and keeping the power at 95% and alpha at 0.05 the sample size for Xpert MTB/RIF is estimated as 25. For smear microscopy the reported sensitivity of 70.47% by Chowdhury R et al was used and sample size of 72 was calculated using same parameters as those for Xpert MTB/RIF. Higher sample size of 72 was taken for conduct of study. Sample size calculations were done using PASS software version 15.0. Frequency of positive tests will be calculated. Mean age will be calculated according to gender and compared by Student's t-test. Sensitivity \& specificity of tests will be calculated using online calculator by VassarStats. Frequency of positive yield of Xpert MTB/RIF will be compared to that of microscopy by χ2- test. P-value of <0.05 was considered significant.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sputum-scarce suspected pulmonary TB
Key inclusion criteria (2 listed)
- Suspicion of Pulmonary TB on history, examination and CXR
- Unable to produce sputum
Key exclusion criteria (1 listed)
- extra pulmonary tuberculosis
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
AFB Positivity
Time frame: 24 Hours
AFB positivity on Xpert RIF/MTB, Culture \& Microscopy
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Background: PubMed 29408360Rakotoarivelo R, Ambrosioni J, Rasolofo V, Raberahona M, Rakotosamimanana N, Andrianasolo R, Ramanampamonjy R, Tiaray M, Razafimahefa J, Rakotoson J, Randria M, Bonnet F, Calmy A; MadaXpert Study Group. Evaluation of the Xpert MTB/RIF assay for the diagnosis of smear-negative pulmonary and extrapulmonary tuberculosis in Madagascar. Int J Infect Dis. 2018 Apr;69:20-25. doi: 10.1016/j.ijid.2018.01.017. Epub 2018 Mar 1.
- Individual participant dataSharing planned: No
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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.
Bader F Zuberi, FCPS study director
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary, run by Faisal Faiyaz Zuberi at 1 site in Pakistan.
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: withdrawn, as of the sponsor's last update on 23 Aug 2021. 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 Pakistan. 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 was withdrawn before enrolling participants, so there are no results.
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?
AFB Positivity (time frame: 24 Hours). 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 NCT03732014, 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 23 Aug 2021.