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Gene Xpert Diagnosis of TB Using Tracheal Aspirates From Intensive Care Unit (ICU) Patients

NCT01530568 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 341

Last updated 2015-01-07

No results posted yet for this study

Summary

Aim:

To evaluate the diagnostic utility and impact on patient outcomes of an automated PCR (Gene Xpert® MTB/RIF), in a group of patients with suspected pulmonary TB who are mechanically ventilated in ICU, using tracheal aspirates.

Hypothesis:

Gene Xpert is an accurate tool for the diagnosis of TB in the Intensive Care Unit and will impact on rates of treatment initiation and hospital stay.

Conditions

Interventions

OTHER

Xpert

This arm receives the GeneXpert test

OTHER

Smear

This arm receives smear microscopy

Sponsors & Collaborators

  • University of Cape Town

    lead OTHER

Principal Investigators

  • Keertan Dheda, PhD · University of Cape Town

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • South Africa

Study Locations

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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 NCT01530568 on ClinicalTrials.gov