Role of Genexpert in Extra Pulmonary Tuberculosis

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03173261
Collaborator
(none)
2
1
15

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Genexpert
N/A

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 Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Jun 1, 2017
Anticipated Primary Completion Date :
Apr 1, 2018
Anticipated Study Completion Date :
Sep 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. the percentage of positive patients for extra pulmonary tuberculosis [10 minutes]

    Count of tuberculosis bacilli in the specimen

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 90 Years
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
lamia saad, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT03173261
Other Study ID Numbers:
  • PTB
First Posted:
Jun 1, 2017
Last Update Posted:
Jun 1, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 1, 2017