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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Extra Pulmonary Tuberculosis

Eligibility Criteria

16 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    May 23, 2017
    Last Updated
    May 31, 2017
    Sponsor
    Assiut University
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    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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