TuberculosisPTBNCT02701439
SMF to Improve Performance of Microscopy for the Diagnosis of PTB in a High HIV Prevalence Setting
An observational study of Tuberculosis, run by Epicentre at 1 site in Uganda.
Trial summary
This study is investigating a better method to see if someone has tuberculosis (TB) as compared to the method that is being used now. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Small membrane filtration
- Type of treatment
- Medical device
- How many people
- 1,050 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2012to Jun 2014
- 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: Adult patients with a suspected diagnosis of pulmonary TB attending two TB clinics in Mbarara, Uganda
Who may be able to join
- Adult (≥18 years)
- Pulmonary TB suspect defined as any person who presents with a productive cough for more than 2 weeks AND accompanied by at least one other respiratory symptom (shortness of breath, chest pains, hemoptysis) and/or constitutional symptom (loss of appetite, weight loss, fever, night sweats, and fatigue) (6).
- Willing to undergo TB evaluation and spontaneously expectorate ≥2 mL of sputum
- Willing to be tested for HIV, if no results available within past 6 months
Who cannot join
- Too ill or unable to provide written consent
- Treated with TB drugs for more than 3 days
- Extra-pulmonary or disseminated TB without pulmonary involvement (i.e. no cough)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Small Membrane Filtration (SMF) Method to Improve the Performance of Smear Microscopy for the Diagnosis of Pulmonary Tuberculosis in a High HIV Prevalence Setting
This study is investigating a better method to see if someone has tuberculosis (TB) as compared to the method that is being used now.
Read the detailed description
TB is a disease caused by a bacterium called Mycobacterium tuberculosis that can affect the lungs or other parts of the body. In most of the world and in Mbarara, Uganda, the method of diagnosis that is used is AFB smear microscopy. This method is widely available, inexpensive and rapid. However, this method's ability to truly detect people having TB is poor. That is, if someone has TB, the test results may say that they are negative, leading to delays in diagnosis, disease progression, and an ongoing transmission of the bacteria.
The new test for TB diagnosis we are studying is called the Small Membrane Filtration (SMF) method. This test that is being compared to the method currently being used and is very similar to the one that is currently used (standard smear microscopy) but has the advantage of concentrating the sputum (mucus) so that we can more easily see if bacteria are present in the sputum. It is hoped that a better way of knowing if someone has TB will help doctors decide when people need to be treated for TB and when not, which will improve the health of patients and help avoid passing the infection to others.
This study will enroll 740 HIV-infected and 310 HIV-uninfected adults with culture confirmed pulmonary TB. These individuals will be identified prospectively at two TB clinics in Mbarara, Uganda.
Study hypothesis: The investigators will assume that one sputum sample will be equivalent to two (null hypothesis) with respect to sensitivity unless we have evidence that the use of two has higher sensitivity (alternative hypothesis). The investigators will assume that SMF is equivalent to AFB smear with respect to sensitivity and specificity unless the investigators find evidence it is superior. The investigators will assume that SMF is equivalent to Xpert unless the investigators find evidence that Xpert is superior.
- Conditions
- Tuberculosis
- Being tested
- Small membrane filtration
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Small membrane filtrationDevice
Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation:
- Abbreviated demographic and clinical evaluation
- TB history and evaluation
- Obtain three sputum samples - one early morning sample and two spot samples
- HIV testing (and CD4 if positive)
- Chest radiograph
- Small membrane filtration intervention will be administered to both arms
| Study group | Role | What they receive |
|---|---|---|
| HIV-infected | Enrollment of 740 HIV-infected adults with suspicion of pulmonary TB.
Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation:
* Abbreviated demographic and clinical evaluation
* TB history and evaluation
* Obtain three sputum samples - one early morning sample and two spot samples
* HIV testing (and CD4 if positive)
* Chest radiograph
* Small membrane filtration intervention Receives: Device: Small membrane filtration | |
| HIV negative | Enrollment of 350 HIV negative adults with suspicion of pulmonary TB.
Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation:
* Abbreviated demographic and clinical evaluation
* TB history and evaluation
* Obtain three sputum samples - one early morning sample and two spot samples
* HIV testing (and CD4 if positive)
* Chest radiograph
* Small membrane filtration intervention Receives: Device: Small membrane filtration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of SMF method and Xpert MTB/RIF assay
The primary endpoints of this laboratory-based study will be to determine the sensitivity and specificity of the SMF method and Xpert MTB/RIF assay, using manual MGIT liquid culture as the gold standard
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 1,050 participants (actual)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Boston University, University of Florida
- Responsible party
- Sponsor
- Investigators
- Yap Boum II, PhD, Principal investigator, Epicentre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701439
- Sponsor's protocol ID
- SMF-01
- Acronym
- PTB
- Status last verified
- Feb 2016
- First submitted
- 16 Feb 2013
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Membrane Filtration (SMF) Method to Improve the Performance of Smear Microscopy for the Diagnosis of Pulmonary Tuberculosis in a High HIV Prevalence Setting
- ClinicalTrials.gov ID
- NCT02701439
- Acronym / sponsor ID
- PTB / SMF-01
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,050 participants (actual)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Boston University, University of Florida
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Mar 2016 (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.
This study is investigating a better method to see if someone has tuberculosis (TB) as compared to the method that is being used now.
Detailed description
TB is a disease caused by a bacterium called Mycobacterium tuberculosis that can affect the lungs or other parts of the body. In most of the world and in Mbarara, Uganda, the method of diagnosis that is used is AFB smear microscopy. This method is widely available, inexpensive and rapid. However, this method's ability to truly detect people having TB is poor. That is, if someone has TB, the test results may say that they are negative, leading to delays in diagnosis, disease progression, and an ongoing transmission of the bacteria.
The new test for TB diagnosis we are studying is called the Small Membrane Filtration (SMF) method. This test that is being compared to the method currently being used and is very similar to the one that is currently used (standard smear microscopy) but has the advantage of concentrating the sputum (mucus) so that we can more easily see if bacteria are present in the sputum. It is hoped that a better way of knowing if someone has TB will help doctors decide when people need to be treated for TB and when not, which will improve the health of patients and help avoid passing the infection to others.
This study will enroll 740 HIV-infected and 310 HIV-uninfected adults with culture confirmed pulmonary TB. These individuals will be identified prospectively at two TB clinics in Mbarara, Uganda.
Study hypothesis: The investigators will assume that one sputum sample will be equivalent to two (null hypothesis) with respect to sensitivity unless we have evidence that the use of two has higher sensitivity (alternative hypothesis). The investigators will assume that SMF is equivalent to AFB smear with respect to sensitivity and specificity unless the investigators find evidence it is superior. The investigators will assume that SMF is equivalent to Xpert unless the investigators find evidence that Xpert is superior.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-infected | – | Device: Small membrane filtrationEnrollment of 740 HIV-infected adults with suspicion of pulmonary TB. Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation: * Abbreviated demographic and clinical evaluation * TB history and evaluation * Obtain three sputum samples - one early morning sample and two spot samples * HIV testing (and CD4 if positive) * Chest radiograph * Small membrane filtration intervention |
| HIV negative | – | Device: Small membrane filtrationEnrollment of 350 HIV negative adults with suspicion of pulmonary TB. Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation: * Abbreviated demographic and clinical evaluation * TB history and evaluation * Obtain three sputum samples - one early morning sample and two spot samples * HIV testing (and CD4 if positive) * Chest radiograph * Small membrane filtration intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a suspected diagnosis of pulmonary TB attending two TB clinics in Mbarara, Uganda
Key inclusion criteria (4 listed)
- Adult (≥18 years)
- Pulmonary TB suspect defined as any person who presents with a productive cough for more than 2 weeks AND accompanied by at least one other respiratory symptom (shortness of breath, chest pains, hemoptysis) and/or constitutional symptom (loss of appetite, weight loss, fever, night sweats, and fatigue) (6).
- Willing to undergo TB evaluation and spontaneously expectorate ≥2 mL of sputum
- Willing to be tested for HIV, if no results available within past 6 months
Key exclusion criteria (3 listed)
- Too ill or unable to provide written consent
- Treated with TB drugs for more than 3 days
- Extra-pulmonary or disseminated TB without pulmonary involvement (i.e. no cough)
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 |
|---|---|---|
| Small membrane filtrationFollowing the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation: * Abbreviated demographic and clinical evaluation * TB history and evaluation * Obtain three sputum samples - one early morning sample and two spot samples * HIV testing (and CD4 if positive) * Chest radiograph * Small membrane filtration intervention will be administered to both arms | Device | HIV negative, HIV-infected |
Primary outcome
Sensitivity and specificity of SMF method and Xpert MTB/RIF assay
Time frame: 24 months
The primary endpoints of this laboratory-based study will be to determine the sensitivity and specificity of the SMF method and Xpert MTB/RIF assay, using manual MGIT liquid culture as the gold standard
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 8 Mar 2016.
- 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.
Yap Boum II, PhD principal investigator
Epicentre
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, run by Epicentre at 1 site in Uganda.
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 4 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 8 Mar 2016. 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 Uganda. 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?
Sensitivity and specificity of SMF method and Xpert MTB/RIF assay (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Mar 2016.