Trial of Point-of-treatment Xpert MTB/RIF Assay

Summary

Xpert MTB/RIF assay is a novel automated molecular tool for the diagnosis of TB. Xpert can detect TB genetic material in sputum samples as well as test for genetic resistance to rifampicin providing results within 2 hours. Xpert received WHO endorsement in December 2010. There is limited data on the impact of Xpert on time-to-treatment and TB-related patient morbidity in primary care clinics. No studies have yet evaluated Xpert performed at the point-of-treatment (POT) i.e. in primary care clinic location. The investigators hypothesize that one sputum GeneXpert MTB/RIF assay performed at the POT will improve time-to-diagnosis, time-to-treatment and TB related patient morbidity for patients with suspected TB presenting to primary level TB clinics in high HIV prevalent settings.

Conditions

• Tuberculosis

Interventions

PROCEDURE

Xpert MTB/RIF assay

Automated nucleic-acid amplification test (fully integrated) test for TB

PROCEDURE

Smear microscopy

Smear microscopy involve sputum smear with either ziehl-neelsen or auramine-O staining of slides and light or fluorescence microscopy reading

Sponsors & Collaborators

• Biomedical Research and Training Institute

  collaborator OTHER

• University of Zimbabwe

  collaborator OTHER

• University of Zambia

  collaborator OTHER

• Medical Research Council, South Africa

  collaborator OTHER

• Mbeya medical research program

  collaborator UNKNOWN

• McGill University

  collaborator OTHER

• Radboud University Medical Center

  collaborator OTHER

• University of Cape Town Lung Institute

  collaborator OTHER

• University of Cape Town

  lead OTHER

Principal Investigators

• Keertan Dheda, MD PhD · University of Cape Town

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2012-07-31

Completion

2012-07-31

Countries

• South Africa
• Zambia
• Zimbabwe

Study Locations