Role of Genexpert in Extra Pulmonary Tuberculosis

May 31, 2017 updated by: lamia saad, Assiut University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 90 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients with extra pulmonary tuberculosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the percentage of positive patients for extra pulmonary tuberculosis
Time Frame: 10 minutes
Count of tuberculosis bacilli in the specimen
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Raafat Talett, Assiut University
  • Study Chair: Yaser Ahmed, Assiut University
  • Study Chair: Ahmed Metwally, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 1, 2017

Primary Completion (ANTICIPATED)

April 1, 2018

Study Completion (ANTICIPATED)

September 1, 2018

Study Registration Dates

First Submitted

May 23, 2017

First Submitted That Met QC Criteria

May 31, 2017

First Posted (ACTUAL)

June 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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