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Role of Genexpert in Extra Pulmonary Tuberculosis

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: NCT03173261
Recruitment Status : Unknown
Verified May 2017 by lamia saad, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Information provided by (Responsible Party):
lamia saad, Assiut University

Brief Summary:

Diagnosis of extra pulmonary tuberculosis remains especially challenging since the number of Mycobacterium tuberculosis bacilli present in tissues at sites of disease is often low and clinical specimens from deep-seated organs may be difficult to obtain. Histology is time-consuming to undertake and establishing a diagnosis of tuberculosis with high specificity remains difficult. Tissue microscopy after special staining is often negative and when mycobacteria are seen, it is impossible to distinguish Mycobacterium tuberculosis from non tuberculous mycobacterial disease. Reliance on culture, the mainstay of diagnosis, often leads to considerable delays, compromising patient care and outcomes.

Evidence from 138 studies published before 2008 suggested that nucleic acid amplification technologies could not replace conventional mycobacterial tests (microscopy, culture) for diagnosing pulmonary and, especially, extra pulmonary tuberculosis

Condition or disease Intervention/treatment Phase
Extra Pulmonary Tuberculosis Diagnostic Test: Genexpert Not Applicable

Detailed Description:
Only a few years later, GeneXpert technology has changed this paradigm, with a recent systematic review showing pooled sensitivity of 88% and pooled specificity of 98% for diagnosis of pulmonary tuberculosis, but evidence (as of March 2012) for using Xpert MTB/RIF for diagnosing extra pulmonary tuberculosis is still comparatively weak Globally, there is still a dearth of studies involving the use of Xpert MTB/RIF in extra pulmonary tuberculosis specimens, and few provide definitive answers. This is due mostly to the studies having small sample sizes across a range of various specimen types and differences in pre-processing methodologies and in input volumes and to studies having been conducted in different populations (adults, children, Human immunodeficiency virus infected).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Genexpert in Extra Pulmonary Tuberculosis
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : April 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
tuberculous pleural effusion
diagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate
Diagnostic Test: Genexpert
diagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate

Primary Outcome Measures :
  1. the percentage of positive patients for extra pulmonary tuberculosis [ Time Frame: 10 minutes ]
    Count of tuberculosis bacilli in the specimen

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients with extra pulmonary tuberculosis

Exclusion Criteria:

  • Severe co morbid diseases.
  • pulmonary tuberculosis
  • patients refuse to do genexpert or refusing

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): NCT03173261

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Contact: Lamiaa wafie, master 01153715388 ext 0882130164

Sponsors and Collaborators
Assiut University
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Study Chair: Raafat Talett Assiut University
Study Chair: Yaser Ahmed Assiut University
Study Chair: Ahmed Metwally Assiut University
Publications of Results:
Other Publications:
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Responsible Party: lamia saad, principal investigator, Assiut University Identifier: NCT03173261    
Other Study ID Numbers: PTB
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections