TuberculosisNRA RETANCT01053598
Evaluation Of The Performance Of The Nitrate Reductase And Resazurin Titre Assay For The Detection of Mycobacterium Tuberculosis Complex From Sputum In A High Tb and Hiv Setting
An observational study of Tuberculosis and HIV, run by Epicentre at 1 site in Uganda.
Trial summary
The Principle objective of this study is To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Tuberculosis, HIV, AIDS
- How many people
- 600 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2011to Dec 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients presenting at the outpatient department of the MRRH will be eligible if they meet the inclusion criteria
Who may be able to join
- Pulmonary TB suspects as defined by a cough for more than 2 weeks
- Age 15 years and above
- Written informed consent signed
Who cannot join
- Producing pure blood sputum or clear saliva
- Producing less than 1 mL of sputum
- Receiving anti TB treatment (isoniazid, rifampicin, streptomycin, pyrazinamide, ethambutol) or quinolone for more than 1 week in the month before inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF THE PERFORMANCE OF THE NITRATE REDUCTASE AND RESAZURIN TITRE ASSAY FOR THE DETECTION OF MYCOBACTERIUM TUBERCULOSIS COMPLEX FROM SPUTUM IN A HIGH TB AND HIV SETTING
The Principle objective of this study is To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard.
The Secondary objectives are:
- To measure the performance of each assay (NRA, NRA-p, REMA-p) in sputum smear-negative patients
- To describe the results of the colorimetric methods in HIV-positive and HIV-negative patients
- To assess the time to detection of both NRA/NRA-p, REMA-p methods.
- To evaluate the feasibility of the NRA, NRA-p, REMA-p methods.
- To determine the rate of contamination of the NRA, NRA-p and REMA-p assays.
- To evaluate the proportion and the clinical relevance of NTM among TB suspects in a high TB and HIV prevalence setting.
- To provide capacity building for TB diagnosis in Mbarara.
Read the detailed description
Tuberculosis (TB) remains a leading cause of death in developing countries and its burden has been exacerbated by the concurrent HIV epidemic. Despite the advances in medicine, TB diagnosis still remains a challenge, especially in developing countries where diagnosis relies mostly on the detection of Mycobacterium tuberculosis complex (MTBC) by smear microscopy and/or culture. Smear microscopy is rapid, simple and not expensive but it lacks sensitivity. Culture on solid medium, which is performed in some well equipped laboratories, is more sensitive than microscopy but takes up to 8 weeks to obtain the result.
Colorimetric methods have been used for the rapid detection of drug sensitivity in M. tuberculosis either from isolates or directly from sputum. These methods rely on the detection of live bacteria through either enzymatic activity (nitrate reduction) or their ability to reduce an oxidation-reduction indicator, either in solid or liquid medium. They are fast, simple, and offer a good potential that should be evaluated for the diagnosis of TB.
The objective of this study is to evaluate the performance of colorimetric assays for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using Löwenstein Jensen (LJ) and Mycobacterium growth indicator tube (MGIT) culture as gold standard. The colorimetric methods evaluated here will be the solid medium-based nitrate reductase assay as described (NRA) or with an additional step using para Nitrobenzoic (PNB) acid for differentiation of MTBC and NTM (NRA-p), and the modified resazurin microplate assay, also using PNB for differentiation of MTBC and NTM (REMA-p).
. If any of the colorimetric assays is found to be accurate, significantly faster than conventional culture methods, and easy to perform, then it could be implemented in a tuberculosis culture laboratory. By reducing the time to detection compared to conventional culture and the costs compared to recent commercial methods, these assays offer a good alternative to conventional methods and might help to improve TB diagnosis in developing countries.
- Conditions
- Tuberculosis, HIV, AIDS, HIV Infections
- Keywords
- Mycobacterium tuberculosis, Nitrate Reductase Assay, NRA, REMA, RETA, Rezazurine
- Medical subject headings
- Tuberculosis, Acquired Immunodeficiency Syndrome, HIV Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard
Measured: 7 Month
Secondary outcomes (1)
-To measure the performance of each assay (NRA, NRA-p, REMA-p) in sputum smear-negative patients -To describe the results of the colorimetric methods in HIV-positive and HIV-negative patients
Measured: 7 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2010 (estimated)
- Study startSep 2011
- Primary completionSep 2012
- Study completionDec 2012
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Epicentre
- Sponsor type
- University, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Medecins Sans Frontieres, Netherlands
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01053598
- Sponsor's protocol ID
- 821183
- Acronym
- NRA RETA
- Status last verified
- Feb 2013
- First submitted
- 19 Jan 2010
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE PERFORMANCE OF THE NITRATE REDUCTASE AND RESAZURIN TITRE ASSAY FOR THE DETECTION OF MYCOBACTERIUM TUBERCULOSIS COMPLEX FROM SPUTUM IN A HIGH TB AND HIV SETTING
- ClinicalTrials.gov ID
- NCT01053598
- Acronym / sponsor ID
- NRA RETA / 821183
- Conditions
- Tuberculosis, HIV, AIDS, HIV Infections
- Keywords
- Mycobacterium tuberculosis, Nitrate Reductase Assay, NRA, REMA, RETA, Rezazurine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- EpicentreUniversity, hospital or other
- Collaborators
- Mbarara University of Science and Technology, Medecins Sans Frontieres, Netherlands
- Study start
- Sep 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 21 Jan 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.
The Principle objective of this study is To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard.
The Secondary objectives are:
- To measure the performance of each assay (NRA, NRA-p, REMA-p) in sputum smear-negative patients
- To describe the results of the colorimetric methods in HIV-positive and HIV-negative patients
- To assess the time to detection of both NRA/NRA-p, REMA-p methods.
- To evaluate the feasibility of the NRA, NRA-p, REMA-p methods.
- To determine the rate of contamination of the NRA, NRA-p and REMA-p assays.
- To evaluate the proportion and the clinical relevance of NTM among TB suspects in a high TB and HIV prevalence setting.
- To provide capacity building for TB diagnosis in Mbarara.
Detailed description
Tuberculosis (TB) remains a leading cause of death in developing countries and its burden has been exacerbated by the concurrent HIV epidemic. Despite the advances in medicine, TB diagnosis still remains a challenge, especially in developing countries where diagnosis relies mostly on the detection of Mycobacterium tuberculosis complex (MTBC) by smear microscopy and/or culture. Smear microscopy is rapid, simple and not expensive but it lacks sensitivity. Culture on solid medium, which is performed in some well equipped laboratories, is more sensitive than microscopy but takes up to 8 weeks to obtain the result.
Colorimetric methods have been used for the rapid detection of drug sensitivity in M. tuberculosis either from isolates or directly from sputum. These methods rely on the detection of live bacteria through either enzymatic activity (nitrate reduction) or their ability to reduce an oxidation-reduction indicator, either in solid or liquid medium. They are fast, simple, and offer a good potential that should be evaluated for the diagnosis of TB.
The objective of this study is to evaluate the performance of colorimetric assays for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using Löwenstein Jensen (LJ) and Mycobacterium growth indicator tube (MGIT) culture as gold standard. The colorimetric methods evaluated here will be the solid medium-based nitrate reductase assay as described (NRA) or with an additional step using para Nitrobenzoic (PNB) acid for differentiation of MTBC and NTM (NRA-p), and the modified resazurin microplate assay, also using PNB for differentiation of MTBC and NTM (REMA-p).
. If any of the colorimetric assays is found to be accurate, significantly faster than conventional culture methods, and easy to perform, then it could be implemented in a tuberculosis culture laboratory. By reducing the time to detection compared to conventional culture and the costs compared to recent commercial methods, these assays offer a good alternative to conventional methods and might help to improve TB diagnosis in developing countries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients presenting at the outpatient department of the MRRH will be eligible if they meet the inclusion criteria
Key inclusion criteria (3 listed)
- Pulmonary TB suspects as defined by a cough for more than 2 weeks
- Age 15 years and above
- Written informed consent signed
Key exclusion criteria (3 listed)
- Producing pure blood sputum or clear saliva
- Producing less than 1 mL of sputum
- Receiving anti TB treatment (isoniazid, rifampicin, streptomycin, pyrazinamide, ethambutol) or quinolone for more than 1 week in the month before inclusion.
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
To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard
Time frame: 7 Month
1 secondary outcome
-To measure the performance of each assay (NRA, NRA-p, REMA-p) in sputum smear-negative patients -To describe the results of the colorimetric methods in HIV-positive and HIV-negative patients
Time frame: 7 Month
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 20 Feb 2013.
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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?
An observational study of Tuberculosis and HIV, 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 3 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 20 Feb 2013. 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?
To evaluate the performance of NRA, NRA-p and REMA-p for the detection of M. tuberculosis complex from sputum samples from adult pulmonary TB suspects in a high TB and HIV prevalence setting, using LJ and MGIT culture as gold standard (time frame: 7 Month). 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 20 Feb 2013.