MedTrace Logo

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

NCT01053598 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2013-02-20

No results posted yet for this study

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.

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.

Conditions

Sponsors & Collaborators

  • Mbarara University of Science and Technology

    collaborator OTHER

  • Medecins Sans Frontieres, Netherlands

    collaborator OTHER

  • Epicentre

    lead OTHER

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-09-30
Completion
2012-12-31

Countries

  • Uganda

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01053598 on ClinicalTrials.gov