Tuberculosis Clinical Trial
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
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Diagnostic
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