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Role of Genexpert in Extra Pulmonary Tuberculosis

Role of Genexpert in Extra Pulmonary Tuberculosis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03173261
Enrollment
2
Registered
2017-06-01
Start date
2017-06-30
Completion date
2018-09-30
Last updated
2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extra Pulmonary Tuberculosis

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).

Interventions

DIAGNOSTIC_TESTGenexpert

diagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frameDescription
the percentage of positive patients for extra pulmonary tuberculosis10 minutesCount of tuberculosis bacilli in the specimen

Contacts

Primary ContactLamiaa wafie, master
lamiasaad079@gmail.com01153715388

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026