Role of Genexpert in Extra Pulmonary Tuberculosis
Primary Purpose
Extra Pulmonary Tuberculosis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Genexpert
Sponsored by
About this trial
This is an interventional diagnostic trial for Extra Pulmonary Tuberculosis
Eligibility Criteria
Inclusion Criteria:
- All patients with extra pulmonary tuberculosis
Exclusion Criteria:
- Severe co morbid diseases.
- pulmonary tuberculosis
- patients refuse to do genexpert or refusing
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
tuberculous pleural effusion
Arm Description
diagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate
Outcomes
Primary Outcome Measures
the percentage of positive patients for extra pulmonary tuberculosis
Count of tuberculosis bacilli in the specimen
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03173261
Brief Title
Role of Genexpert in Extra Pulmonary Tuberculosis
Official Title
Role of Genexpert in Extra Pulmonary Tuberculosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extra Pulmonary Tuberculosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tuberculous pleural effusion
Arm Type
Other
Arm Description
diagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate
Intervention Type
Diagnostic Test
Intervention Name(s)
Genexpert
Intervention Description
diagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate
Primary Outcome Measure Information:
Title
the percentage of positive patients for extra pulmonary tuberculosis
Description
Count of tuberculosis bacilli in the specimen
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with extra pulmonary tuberculosis
Exclusion Criteria:
Severe co morbid diseases.
pulmonary tuberculosis
patients refuse to do genexpert or refusing
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lamiaa wafie, master
Phone
01153715388
Ext
0882130164
Email
lamiasaad079@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raafat Talett
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Yaser Ahmed
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Metwally
Organizational Affiliation
Assiut University
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20825313
Citation
Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.
Results Reference
background
PubMed Identifier
21420161
Citation
Lawn SD, Zumla AI. Tuberculosis. Lancet. 2011 Jul 2;378(9785):57-72. doi: 10.1016/S0140-6736(10)62173-3. Epub 2011 Mar 21.
Results Reference
result
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Role of Genexpert in Extra Pulmonary Tuberculosis
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