Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06409572
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-07
Brief Title:
Study of GeneXpert Mycobacterium Tuberculosis Rifampicin MTBRIF Versus the Routine Methods for Detection of Mycobacterium Tuberculosis
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Study of GeneXpert MTBRIF Versus the Routine Methods for Detection of Mycobacterium Tuberculosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
1 Compare the performance of GeneXpert method with the routine methods including smear microscopy and Lowenstein-Jensen LJ media culture to choose the best available test for the diagnosis of TB
2 To assess the GeneXpert MTBRIF assay performance in detection of Mycobacterium tuberculosis in smear-negative sputum samples
2 To assess the GeneXpert MTBRIF assay performance in detection of Mycobacterium tuberculosis in smear-negative sputum samples
Detailed Description:
Tuberculosis TB infection caused by Mycobacterium tuberculosis is a leading cause of mortality worldwide and ranks among the deadliest infectious diseases including HIV and malaria Despite global efforts TB remains a significant public health threat particularly in developing and underdeveloped countries The World Health Organization WHO has reported that an estimated 104 million people contract new TB infections yearly with 18 million TB-related deaths occurring annually
TB usually affects the lungs but it can also affect other parts of the body such as the brain spine and many other organ systems The most common form is pulmonary TB which is easily spread by aerosol droplets If another person inhales air containing these droplet nuclei the probability of getting infected is very high The chance of transmissibility increases if there is a delay in disease detection and treatment initiation
Tuberculosis is an infection that requires extensive treatment Active pulmonary TB patients can transmit the infection through the air then the droplet nuclei move through upper respiratory tract and bronchi to reach the lungs alveoli
It is critical to treat active pulmonary TB patients as soon as possible in order to decrease the danger of infection spreading to others The initial stage in TB diagnosis is sputum acid fast bacillus AFB staining which has an advantage of having an average turnaround time TAT about 24 hours
There are a number of tests available for the diagnosis of tuberculosis each having their own limitations Conventional microscopy has low sensitivity and culture requires longer time for positivity The commercially available automated liquid Mycobacterium Growth Indicator tube MGIT culture system is time-consuming and requires specialized laboratories On the other side nucleic acid amplification techniques not only provide the advantage of rapidity of diagnosis but also detect even low genomic copies in various specimens and curtail the transmission of the disease
The World Health Organization WHO has endorsed the implementation of GeneXpert MTBRIF assay for national tuberculosis programs in developing countries The GeneXpert MTBRIF is an automated user friendly and rapid test based on nested real-time polymerase chain reaction PCR assay and molecular beacon technology for MTB detection and RIF resistance
The results are obtained within a short period of time 2 h Moreover this technique is not prone to cross-contamination requires minimal Biosafety facilities and has a high sensitivity in smear-negative pulmonary TB The diagnosis of extrapulmonary tuberculosis EPTB is often difficult to establish considering that number of bacteria in specimens is often very low a collection often requires invasive procedures and it is not easy to obtain multiple samples In this scenario GeneXpert is a potentially useful tool for extrapulmonary specimens
TB usually affects the lungs but it can also affect other parts of the body such as the brain spine and many other organ systems The most common form is pulmonary TB which is easily spread by aerosol droplets If another person inhales air containing these droplet nuclei the probability of getting infected is very high The chance of transmissibility increases if there is a delay in disease detection and treatment initiation
Tuberculosis is an infection that requires extensive treatment Active pulmonary TB patients can transmit the infection through the air then the droplet nuclei move through upper respiratory tract and bronchi to reach the lungs alveoli
It is critical to treat active pulmonary TB patients as soon as possible in order to decrease the danger of infection spreading to others The initial stage in TB diagnosis is sputum acid fast bacillus AFB staining which has an advantage of having an average turnaround time TAT about 24 hours
There are a number of tests available for the diagnosis of tuberculosis each having their own limitations Conventional microscopy has low sensitivity and culture requires longer time for positivity The commercially available automated liquid Mycobacterium Growth Indicator tube MGIT culture system is time-consuming and requires specialized laboratories On the other side nucleic acid amplification techniques not only provide the advantage of rapidity of diagnosis but also detect even low genomic copies in various specimens and curtail the transmission of the disease
The World Health Organization WHO has endorsed the implementation of GeneXpert MTBRIF assay for national tuberculosis programs in developing countries The GeneXpert MTBRIF is an automated user friendly and rapid test based on nested real-time polymerase chain reaction PCR assay and molecular beacon technology for MTB detection and RIF resistance
The results are obtained within a short period of time 2 h Moreover this technique is not prone to cross-contamination requires minimal Biosafety facilities and has a high sensitivity in smear-negative pulmonary TB The diagnosis of extrapulmonary tuberculosis EPTB is often difficult to establish considering that number of bacteria in specimens is often very low a collection often requires invasive procedures and it is not easy to obtain multiple samples In this scenario GeneXpert is a potentially useful tool for extrapulmonary specimens
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None