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

NCT01530568 | Completed

• 1 other identifier: TB Xpert ICU
• Study Type: interventional
• Target: 341
• Locations: 1 country
• Sites: 1

Brief 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

Tuberculosis

Keywords

Intensive care, TB, tracheal aspirates, Gene Xpert

Outcome Measures

Primary Outcomes (1)

• Rates of TB treatment initiation

  The proportion of patients on TB treatment in each arm will be compared longitudinally

  48 hours

Secondary Outcomes (3)

• Mortality in ICU

  up to 2 months

• Duration of mechanical ventilation

  Up to 2 weeks

• ICU length of stay

  up to 3 months

Study Arms (2)

Smear

ACTIVE COMPARATOR

Routine microbiology based diagnostics for TB

Other: Smear

GeneXpert

EXPERIMENTAL

Arm that will receive the Xpert test

Other: Xpert

Interventions

Xpert OTHER

This arm receives the GeneXpert test

GeneXpert

Smear OTHER

This arm receives smear microscopy

Smear

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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)).

You may not qualify if:

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

Sponsors & Collaborators

• University of Cape Town: lead

Study Sites (1)

Groote Schuur Hospital, which operates within the Cape Town Central Health District of the Metro Region

Cape Town, Western Cape, 7925, South Africa

Location

Related Publications (1)

• Calligaro GL, Theron G, Khalfey H, Peter J, Meldau R, Matinyenya B, Davids M, Smith L, Pooran A, Lesosky M, Esmail A, Miller MG, Piercy J, Michell L, Dawson R, Raine RI, Joubert I, Dheda K. Burden of tuberculosis in intensive care units in Cape Town, South Africa, and assessment of the accuracy and effect on patient outcomes of the Xpert MTB/RIF test on tracheal aspirate samples for diagnosis of pulmonary tuberculosis: a prospective burden of disease study with a nested randomised controlled trial. Lancet Respir Med. 2015 Aug;3(8):621-30. doi: 10.1016/S2213-2600(15)00198-8. Epub 2015 Jul 22.

  PMID: 26208996 DERIVED

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Keertan Dheda, PhD

  University of Cape Town

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 24, 2012
• First Posted: February 10, 2012
• Study Start: August 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: January 7, 2015

Record last verified: 2015-01

Locations

ZA (1)