Study of GeneXpert Mycobacterium Tuberculosis/ Rifampicin (MTB/RIF) Versus the Routine Methods for Detection of Mycobacterium Tuberculosis

NCT06409572 | Not Yet Recruiting

• 1 other identifier: Soh-Med-24-4-08MD
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 2.To assess the GeneXpert MTB/RIF assay performance in detection of Mycobacterium tuberculosis in smear-negative sputum samples.

Conditions

Tuberculosis

Outcome Measures

Primary Outcomes (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.

  Baseline

Interventions

GeneXpert MTB/RIF DIAGNOSTIC_TEST

Rapid and accurate method for detection of tuberculosis.

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1. Sampling:Morning sputum samples or any suspected fluid as pleural or pus. 2. Laboratory investigations: 1. Direct Smear Preparation and Ziehl-Neelsen staining. 2. MTB culture on Lowenstein-Jensen (LJ) media 3. Gene-Xpert MTB/RIF assay.

You may qualify if:

• All suspected tuberculous patients.

You may not qualify if:

• children
• Previously diagnosed patients.

Sponsors & Collaborators

• Sohag University: lead

Related Publications (1)

• AGRAWAL, M., BAJAJ, A., BHATIA, V. & DUTT, S. 2016. Comparative study of GeneXpert with ZN stain and culture in samples of suspected pulmonary tuberculosis. Journal of clinical and diagnostic research: JCDR, 10, DC09. GONG, X., HE, Y., ZHOU, K., HUA, Y. & LI, Y. 2023. Efficacy of Xpert in tuberculosis diagnosis based on various specimens: a systematic review and meta-analysis. Frontiers in Cellular and Infection Microbiology, 13, 500. GUENAOUI, K., HARIR, N., OUARDI, A., ZEGGAI, S., SELLAM, F., BEKRI, F. & TOUIL, S. C. 2016. Use of GeneXpert Mycobacterium tuberculosis/rifampicin for rapid detection of rifampicin resistant Mycobacterium tuberculosis strains of clinically suspected multi-drug resistance tuberculosis cases. Annals of translational medicine, 4. KHAN, A. S., ALI, S., KHAN, M. T., AHMED, S., KHATTAK, Y., IRFAN, M. & SAJJAD, W. 2018. Comparison of GeneXpert MTB/RIF assay and LED-FM microscopy for the diagnosis of extra pulmonary tuberculosis in Khyber Pakhtunkhwa, Pakistan. brazilian journal of microbiology, 49, 909-913. KHATER, E. S. & ABDO, K. H. 2022. Role of Gene-Xpert MTB/RIF assay in detection of Mycobacterium tuberculosis in smear-negative sputum samples. Microbes and Infectious Diseases, 3, 606-614. WILLIAM, T., PARAMESWARAN, U., LEE, W. K., YEO, T. W., ANSTEY, N. M. & RALPH, A. P. 2015. Pulmonary tuberculosis in outpatients in Sabah, Malaysia: advanced disease but low incidence of HIV co-infection. BMC infectious diseases, 15, 1-9. ZUMLA, A., GEORGE, A., SHARMA, V., HERBERT, R. H. N., OXLEY, A. & OLIVER, M. 2015. The WHO 2014 global tuberculosis report-further to go. The Lancet Global Health, 3, e10-e12.

  BACKGROUND

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Central Study Contacts

Esraa Hussien Mahran Shehata, MD

CONTACT

01009003285; e.shehata90@yahoo.com

Laila Mohammed yousef, Prof.Dr.

CONTACT

01002976973; lelysaeed@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 13, 2024

Record last verified: 2024-05