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

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. Identifier: NCT01530568
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : January 7, 2015
Information provided by (Responsible Party):
Keertan Dheda, University of Cape Town

Brief Summary:


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.


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.

Condition or disease Intervention/treatment Phase
Tuberculosis Other: Xpert Other: Smear Not Applicable

Detailed Description:

Background Tuberculosis (TB) is a serious global public health emergency and there is a great need for the improvement of current diagnostic tools and the evaluation of newer and novel technologies for the rapid diagnosis of TB. The most common testing method for TB is sputum smear microscopy, which has remained largely unchanged in its sophistication and sensitivity. Smear microscopy detects around 50% of all active TB cases and is not capable of identifying drug resistance. Furthermore, even though culture is more accurate results are only available in several weeks. Treating patients empirically for TB exposes patients to the toxic side-effects of drugs, and if there is no response to treatment, raises the question of MDR-TB. These considerations apply to clinical decision-making in the ICU where TB is not infrequently encountered. A diagnosis of TB in this setting has important implications for drug-drug interactions, route of administration, and drug toxicity.

The Gene Xpert® system's MTB/RIF Assay, an on-demand molecular test for simultaneous detection of Mycobacterium tuberculosis (M.tb) and rifampicin (RIF) resistance, has recently been released. This is the only system that combines on-board sample preparation with real-time PCR [1]. Helb and colleagues developed and performed the first analysis of the Cepheid Gene Xpert System's MTB/RIF assay. They evaluated the diagnostic utility of the system using sputum samples and showed that the system was highly sensitive and simple-to-use [2]. A recent paper (NEJM, 2010, in press) that enrolled almost 2000 patients found Xpert to have a sensitivity of almost 90% in smear-negative TB. However, how the test will perform when using tracheal aspirates is unknown. It is also unclear whether the test will have any impact in the ICU where the decision to treat is often made clinically and empiric treatment is initiated. To address these questions we aim to obtain tracheal aspirates from about 120 mechanically ventilated patients with suspected TB from the Groote Schuur Hospital Intensive Care Unit. Tests will be conducted at the Lung Infection and Immunity Unit laboratory (Groote Schuur Hospital, Cape Town) to evaluate the diagnostic utility of the Xpert® MTB/RIF Assay in this group of patients. The expected study period will be 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 341 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Diagnostic
Official Title: A Randomised Control Trial of a Standardised and User-friendly Real-time PCR Assay for the Diagnosis of TB Using Tracheal Aspirates Obtained From Patients in the ICU
Study Start Date : August 2010
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Smear
Routine microbiology based diagnostics for TB
Other: Smear
This arm receives smear microscopy

Experimental: GeneXpert
Arm that will receive the Xpert test
Other: Xpert
This arm receives the GeneXpert test

Primary Outcome Measures :
  1. Rates of TB treatment initiation [ Time Frame: 48 hours ]
    The proportion of patients on TB treatment in each arm will be compared longitudinally

Secondary Outcome Measures :
  1. Mortality in ICU [ Time Frame: up to 2 months ]
    The time-specific proportion of patients who have died prior to discharge will be compared across arms

  2. Duration of mechanical ventilation [ Time Frame: Up to 2 weeks ]
    The median Duration of mechanical ventilation will be compared between arms prior to discharge up to 2 weeks

  3. ICU length of stay [ Time Frame: up to 3 months ]
    The median ICU length of stay will be compared up to 3 months

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

1. Any ventilated patients over 18 years of age with suspected TB (suggestive pulmonary infiltrates, a history of constitutional symptoms preceding the ICU admission, or patients known or suspected to be infected with the human immunodeficiency virus (HIV)).

Exclusion criteria:

1. Patients known to have active TB or to already be on antituberculous medication.

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 identifier (NCT number): NCT01530568

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South Africa
Groote Schuur Hospital, which operates within the Cape Town Central Health District of the Metro Region
Cape Town, Western Cape, South Africa, 7925
Sponsors and Collaborators
University of Cape Town
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Principal Investigator: Keertan Dheda, PhD University of Cape Town
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Keertan Dheda, Professor, University of Cape Town Identifier: NCT01530568    
Other Study ID Numbers: TB Xpert ICU
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015
Keywords provided by Keertan Dheda, University of Cape Town:
Intensive care, TB, tracheal aspirates, Gene Xpert
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections