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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 (NRA RETA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01053598
First Posted: January 21, 2010
Last Update Posted: February 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mbarara University of Science and Technology
Medecins Sans Frontieres, Netherlands
Information provided by (Responsible Party):
Epicentre
  Purpose

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.

Condition
Tuberculosis HIV AIDS HIV Infections

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Epicentre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • -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 ]

Estimated Enrollment: 600
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients presenting at the outpatient department of the MRRH will be eligible if they meet the inclusion criteria
Criteria

Inclusion Criteria:

  • Pulmonary TB suspects as defined by a cough for more than 2 weeks
  • Age 15 years and above
  • Written informed consent signed

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053598


Locations
Uganda
Epicentre
Mbarara, Uganda, 1956
Sponsors and Collaborators
Epicentre
Mbarara University of Science and Technology
Medecins Sans Frontieres, Netherlands
  More Information

Responsible Party: Epicentre
ClinicalTrials.gov Identifier: NCT01053598     History of Changes
Other Study ID Numbers: 821183
First Submitted: January 19, 2010
First Posted: January 21, 2010
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Epicentre:
Mycobacterium tuberculosis
Nitrate Reductase Assay
NRA
REMA
RETA
Rezazurine

Additional relevant MeSH terms:
HIV Infections
Tuberculosis
Mycobacterium Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections