Performance of Xpert MTB/RIF and XDR Assay for Diagnosis of Pulmonary Tuberculosis and Resistant Pulmonary TB

NCT06392594 | Not Yet Recruiting

• 1 other identifier: Pulmonary Tuberculosis xpert
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine how accurate Xpert MTB/RIF and XDR for diagnosis of pulmonary TB and Rifampicin resistance

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

• To detect the performance of xpert MTB/RIF for detection of pulmonary tuberculosis and detection of rifampicin resistant • to detect the diagnostic accuracy of XDR in diagnosis of INH and rifampicin resistance in positive cases of xpert MTB /RIF

  All Patients with respiratory symptoms suggestive of pulmonary TB will go for • Sputum for * acid fast bacilli * culture (the gold standard ) * Gene xpert or ultra expert * XDR (For positive gene xpert or ultra xpert to detect the accuracy of gene xpert in diagnosis of pulmonary tuberculosios and rifampicin resistant

  baseline

Secondary Outcomes (1)

• To assess the frequency of Xpert Ultra trace positive results . to investigate the effect of smear positive and smear negative on test accuracy

  baseline

Interventions

xpert MTB , XDR assay GENETIC

To determine how accurate Xpert MTB/RIF and XDR for diagnosis of pulmonary TB and Rifampicin resistance

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with respiratory symptoms suggestive of pulmonary T.B like productive cough for \>3 weeks, cough of any duration accompanied by constitutional symptoms (fever for at least 3 days, night sweats or weight loss of at least 3 kg in the previous month), or hemoptysis with radiological finding suggestive of pulmonary tb

You may qualify if:

• \. Patients with respiratory symptoms suggestive of pulmonary T.B 2. Patients who were able to collect a sputum sample were included in the study 3. Patients with positive xpert MTB/RIF for XDR assay

You may not qualify if:

• Patients who were unable to collect a sputum sample Patient with negative xpert MTB/RIF for XDR assay Patients with extrapulmonary tb Patients with positive culture for MOTT

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Mohamed Esmat

CONTACT

01064780592; drmhmddr@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor of pulmonologist

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: April 23, 2024
• Primary Completion: April 23, 2025
• Study Completion: May 23, 2025
• Last Updated: April 30, 2024

Record last verified: 2024-04