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The Utility of Intensified Case Finding Combined With a Package of Novel TB Diagnostics Using a Mobile Clinic in Africa

NCT01990274 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 875

Last updated 2015-11-25

No results posted yet for this study

Summary

The purpose of this study is to compare two different methods of intensified tuberculosis (TB) case finding in the community. These methods all involve the use of a mobile clinic to reach people with TB symptoms who are not able to readily access clinic services. A standard diagnostics package consisting of smear microscopy and culture (with smear result available the next day) will be compared with a novel diagnostics package involving point-of-care sputum GeneXpert MTB/RIF performed at a mobile or conventional clinic (with same day result), sputum culture, and lateral flow urinary lipoarabinomannan (LAM) testing (in HIV +ve subjects only). The primary outcome is a comparison between the number of culture +ve subjects on TB treatment in each group at the end of two months. A secondary aim is an evaluation of the accuracy and feasibility of GeneXpert performed in a mobile clinic. Additional study aims include using chest X-rays obtained during the study to develop and validate of an computer-aided diagnosis (CAD) software package for TB (together with collaborators in the Netherlands), as well as establishing whether LAM is detectable at sub-ELISA concentrations in the urine of those with TB.

Conditions

Interventions

PROCEDURE

GeneXpert 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

  • University of Zimbabwe

    collaborator OTHER

  • Università degli Studi di Sassari

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Keertan Dheda, MBChB, PhD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Italy
  • Netherlands
  • South Africa
  • Zimbabwe

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 NCT01990274 on ClinicalTrials.gov