Tuberculosis, PulmonaryNCT01381757
Utility of MODS for Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing in Mali
An observational study of Tuberculosis, Pulmonary and Mycobacterium Tuberculous, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
Trial summary
Background: -Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed with a test that is fast and inexpensive but not always accurate. The purpose of this study is to test a new method for diagnosing TB, called the microscopic-observation drug-susceptibility (MODS) test. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary, Mycobacterium Tuberculous, Antitubercular Agents
- How many people
- 34 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 May 2011to 5 Mar 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals (12 years of age) who meet the following criteria are eligible for enrollment in the study:
- Have a sputum smear that is positive for acid-fast bacilli by microscopy or have clinical symptoms and abnormal findings compatible with active TB on a previously performed chest radiograph.
- Have either completed at least 5 months of treatment with antituberculous therapy within the past year or have not received any antituberculous treatment in the preceding 5 years.
- Willingness to provide a sputum sample for the study.
- Ability to follow verbal instructions for producing sputum.
- Willingness to undergo testing for HIV.
- Willingness to allow storage of samples for future research.
Who cannot join
- Subjects who meet any of the following criteria are not eligible for enrollment in the study:
- Any condition that in the investigator s opinion places the subject at undue risk by participating in the study.
- Subjects younger than 12 years of age will be excluded from the study due to the difficulty of obtaining adequate sputum samples for the diagnosis of TB in this population and because there are no means for obtaining gastric aspirates at the reference centers.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pi
Bethesda, Maryland, 20892
About this study
Official title: Uitlity of MODS for the Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing in Mali
Background:
-Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed with a test that is fast and inexpensive but not always accurate. The purpose of this study is to test a new method for diagnosing TB, called the microscopic-observation drug-susceptibility (MODS) test. The MODS test takes 7 days to show results. The test also gives information on which drugs will work best in each case.
Read more
Objective:
-To test a new method for diagnosing tuberculosis called the microscopic observation drug susceptibility test.
Eligibility:
- Participants must be 12 years of age or older.
- They must have a diagnosis of TB from a sputum smear, or have symptoms of TB and an x-ray indicating that TB is present.
Design:
- Participants will take part in the study from 6 months to 21 months and be assigned to one of three groups, depending on what type of TB they have.
- At the first visit, researchers ask questions about general health and symptoms of TB. They check vital signs, draw blood, and ask for a sputum sample. The blood is used to check for HIV infection and for the number of CD4 cells, which measures the severity of the HIV infection.
- The 2-, 5-, and 6-month visits are similar to the first. Those who do not have multidrug-resistant (MDR) TB will end their participation after the 6-month visit. MDR TB is tuberculosis that has not responded to isoniazid and rifampicin. Participants with MDR TB will remain in the study for 21 months.
- No treatment is provided as part of this study.
Read the detailed description
Approximately one-third of the world s population is infected with tuberculosis (TB), and over 1 million deaths occur annually worldwide because of it (1,2). Accurate diagnosis and TB drug susceptibility testing is necessary to treat the infection appropriately and bring this epidemic under control. Inappropriate treatment of TB, on the other hand, has led to the recent spread in multidrug-resistant TB (MDR-TB), estimated to affect over half of million people worldwide (2,4,5). Sputum smear microscopy, the diagnostic method commonly used in developing countries, is not as sensitive at detecting TB as culture-based techniques utilized in developed countries. Furthermore, drug-susceptibility testing is not routinely performed in resource-limited settings. Consequently, many individuals with TB in developing countries are treated with inadequate regimens, and MDR-TB continues to spread.
The microscopic-observation drug-sensitivity (MODS) assay has been recently developed for rapid diagnosis of TB and simultaneous detection of resistance to first-line TB medications in resource-limited settings (11). MODS has been shown to be as sensitive as traditional culturebased methods for the detection of TB, providing results for drug susceptibility testing that are highly concordant with standard techniques (10).
We propose to study the utility of the MODS assay for the diagnosis of TB in subjects who are sputum-smear positive or sputum-smear negative, and those with chronic TB. Susceptibility testing will be performed for first-line antituberculous drugs and, subsequently, second-line drugs, if subjects are found to have MDR-TB. The first primary objective is to calculate the sensitivity of detection of the MODS assay, compared with the Middlebrook culture method, in subjects suspected of having TB who are sputum-smear positive by microscopy. The second primary objective is to calculate the concordance of drug-susceptibility testing between the MODS assay and the agar proportion method for subjects who are sputum-smear positive, sputum-smear negative, or diagnosed with chronic TB.
Secondary objectives include evaluating the utility of the MODS assay in the diagnosis of TB in subjects who are sputum-smear negative and those with chronic TB, the performance of second-line drug-susceptibility testing using the MODS assay in subjects diagnosed with MDRTB, the utility of the MODS assay in the diagnosis of TB in subjects coinfected with human immunodeficiency virus (HIV)-1 or -2, and the ability of the MODS assay to identify nontuberculous mycobacteria in subjects harboring these organisms.
- Conditions
- Tuberculosis, Pulmonary, Mycobacterium Tuberculous, Antitubercular Agents, Tuberculosis, Mulutidrug-Resistant, Extensively Drug-Resistant, Extensibely Drug-Resistant Tuberculosis
- Keywords
- Extensively Drug-Resistant Tuberculosis, First-Line Antituberculous Drugs, Second-Line Antituberculous Drugs, Middlebrook Culture, Agar Proportion Method
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis, Extensively Drug-Resistant Tuberculosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study start31 May 2011
- Study completion5 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Sophia B Siddiqui, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381757
- Sponsor's protocol ID
- 999911175
- Other IDs
- 11-I-N175
- Status last verified
- 5 Mar 2013
- First submitted
- 23 Jun 2011
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Chan ED, Iseman MD. Multidrug-resistant and extensively drug-resistant tuberculosis: a review. Curr Opin Infect Dis. 2008 Dec;21(6):587-95. doi: 10.1097/QCO.0b013e328319bce6.
PubMed 18978526Nathanson E, Nunn P, Uplekar M, Floyd K, Jaramillo E, Lonnroth K, Weil D, Raviglione M. MDR tuberculosis--critical steps for prevention and control. N Engl J Med. 2010 Sep 9;363(11):1050-8. doi: 10.1056/NEJMra0908076. No abstract available.
PubMed 20825317Gandhi NR, Nunn P, Dheda K, Schaaf HS, Zignol M, van Soolingen D, Jensen P, Bayona J. Multidrug-resistant and extensively drug-resistant tuberculosis: a threat to global control of tuberculosis. Lancet. 2010 May 22;375(9728):1830-43. doi: 10.1016/S0140-6736(10)60410-2.
PubMed 20488523
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uitlity of MODS for the Diagnosis of MDR-TB and Second-Line Antituberculous Drug Susceptibility Testing in Mali
- ClinicalTrials.gov ID
- NCT01381757
- Acronym / sponsor ID
- 999911175
- Conditions
- Tuberculosis, Pulmonary, Mycobacterium Tuberculous, Antitubercular Agents, Tuberculosis, Mulutidrug-Resistant, Extensively Drug-Resistant, Extensibely Drug-Resistant Tuberculosis
- Keywords
- Extensively Drug-Resistant Tuberculosis, First-Line Antituberculous Drugs, Second-Line Antituberculous Drugs, Middlebrook Culture, Agar Proportion Method
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 31 May 2011
- Study completion
- 5 Mar 2013
- First posted
- 27 Jun 2011 (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.
Background:
-Tuberculosis (TB) is an infection of the lungs caused by bacteria. In Mali, TB is diagnosed with a test that is fast and inexpensive but not always accurate. The purpose of this study is to test a new method for diagnosing TB, called the microscopic-observation drug-susceptibility (MODS) test. The MODS test takes 7 days to show results. The test also gives information on which drugs will work best in each case.
Objective:
-To test a new method for diagnosing tuberculosis called the microscopic observation drug susceptibility test.
Eligibility:
- Participants must be 12 years of age or older.
- They must have a diagnosis of TB from a sputum smear, or have symptoms of TB and an x-ray indicating that TB is present.
Design:
- Participants will take part in the study from 6 months to 21 months and be assigned to one of three groups, depending on what type of TB they have.
- At the first visit, researchers ask questions about general health and symptoms of TB. They check vital signs, draw blood, and ask for a sputum sample. The blood is used to check for HIV infection and for the number of CD4 cells, which measures the severity of the HIV infection.
- The 2-, 5-, and 6-month visits are similar to the first. Those who do not have multidrug-resistant (MDR) TB will end their participation after the 6-month visit. MDR TB is tuberculosis that has not responded to isoniazid and rifampicin. Participants with MDR TB will remain in the study for 21 months.
- No treatment is provided as part of this study.
Detailed description
Approximately one-third of the world s population is infected with tuberculosis (TB), and over 1 million deaths occur annually worldwide because of it (1,2). Accurate diagnosis and TB drug susceptibility testing is necessary to treat the infection appropriately and bring this epidemic under control. Inappropriate treatment of TB, on the other hand, has led to the recent spread in multidrug-resistant TB (MDR-TB), estimated to affect over half of million people worldwide (2,4,5). Sputum smear microscopy, the diagnostic method commonly used in developing countries, is not as sensitive at detecting TB as culture-based techniques utilized in developed countries. Furthermore, drug-susceptibility testing is not routinely performed in resource-limited settings. Consequently, many individuals with TB in developing countries are treated with inadequate regimens, and MDR-TB continues to spread.
The microscopic-observation drug-sensitivity (MODS) assay has been recently developed for rapid diagnosis of TB and simultaneous detection of resistance to first-line TB medications in resource-limited settings (11). MODS has been shown to be as sensitive as traditional culturebased methods for the detection of TB, providing results for drug susceptibility testing that are highly concordant with standard techniques (10).
We propose to study the utility of the MODS assay for the diagnosis of TB in subjects who are sputum-smear positive or sputum-smear negative, and those with chronic TB. Susceptibility testing will be performed for first-line antituberculous drugs and, subsequently, second-line drugs, if subjects are found to have MDR-TB. The first primary objective is to calculate the sensitivity of detection of the MODS assay, compared with the Middlebrook culture method, in subjects suspected of having TB who are sputum-smear positive by microscopy. The second primary objective is to calculate the concordance of drug-susceptibility testing between the MODS assay and the agar proportion method for subjects who are sputum-smear positive, sputum-smear negative, or diagnosed with chronic TB.
Secondary objectives include evaluating the utility of the MODS assay in the diagnosis of TB in subjects who are sputum-smear negative and those with chronic TB, the performance of second-line drug-susceptibility testing using the MODS assay in subjects diagnosed with MDRTB, the utility of the MODS assay in the diagnosis of TB in subjects coinfected with human immunodeficiency virus (HIV)-1 or -2, and the ability of the MODS assay to identify nontuberculous mycobacteria in subjects harboring these organisms.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Individuals (12 years of age) who meet the following criteria are eligible for enrollment in the study:
- Have a sputum smear that is positive for acid-fast bacilli by microscopy or have clinical symptoms and abnormal findings compatible with active TB on a previously performed chest radiograph.
- Have either completed at least 5 months of treatment with antituberculous therapy within the past year or have not received any antituberculous treatment in the preceding 5 years.
- Willingness to provide a sputum sample for the study.
- Ability to follow verbal instructions for producing sputum.
Key exclusion criteria (3 listed)
- Subjects who meet any of the following criteria are not eligible for enrollment in the study:
- Any condition that in the investigator s opinion places the subject at undue risk by participating in the study.
- Subjects younger than 12 years of age will be excluded from the study due to the difficulty of obtaining adequate sputum samples for the diagnosis of TB in this population and because there are no means for obtaining gastric aspirates at the reference centers.
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
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 18978526Chan ED, Iseman MD. Multidrug-resistant and extensively drug-resistant tuberculosis: a review. Curr Opin Infect Dis. 2008 Dec;21(6):587-95. doi: 10.1097/QCO.0b013e328319bce6.
- Background: PubMed 20825317Nathanson E, Nunn P, Uplekar M, Floyd K, Jaramillo E, Lonnroth K, Weil D, Raviglione M. MDR tuberculosis--critical steps for prevention and control. N Engl J Med. 2010 Sep 9;363(11):1050-8. doi: 10.1056/NEJMra0908076. No abstract available.
- Background: PubMed 20488523Gandhi NR, Nunn P, Dheda K, Schaaf HS, Zignol M, van Soolingen D, Jensen P, Bayona J. Multidrug-resistant and extensively drug-resistant tuberculosis: a threat to global control of tuberculosis. Lancet. 2010 May 22;375(9728):1830-43. doi: 10.1016/S0140-6736(10)60410-2.
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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.
Sophia B Siddiqui, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary and Mycobacterium Tuberculous, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in 2 countries.
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 7 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: stopped early, as of the sponsor's last update on 5 Apr 2018. 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 United States, Mali. 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 stopped early. Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01381757, which also lists 3 linked publications.
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 5 Apr 2018.