Pulmonary and Extra- Pulmonary Tuberculosis (TB)NCT07169149
Study About Drug Resistance of Mycobacterium Tuberculosis
An observational study of Pulmonary and Extra- Pulmonary Tuberculosis (TB), run by Sohag University at 1 site in Egypt.
Trial summary
Tuberculosis is a major cause of ill health and one of the leading causes of death worldwide. Early, rapid and accurate diagnosis of all TB patients and prompt treatment with any form of drug-susceptible or drug resistant TB is fundamental. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pulmonary and Extra- Pulmonary Tuberculosis (TB)
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2025to Feb 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Child, Adult, Older adult
Study population: patients with geneXpert positive samples whether rifampicin resistant or sensitive
Who may be able to join
- geneXpert positive patients in pulmonary and extrapulmonary cases
Who cannot join
- age below 12 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Sohag University
Sohag
Omnia abdelazeem Zahran, specialist, +2 01113328989, omnia_zahran@med.sohag.edu.eg
About this study
Official title: Study of the Prevalence and Patterns of Drug Resistance of Mycobacterium Tuberculosis Using GeneXpert (MTB/RIF) and Xpert (MTB/XDR) Assays
Tuberculosis is a major cause of ill health and one of the leading causes of death worldwide. Early, rapid and accurate diagnosis of all TB patients and prompt treatment with any form of drug-susceptible or drug resistant TB is fundamental. Identifying the pattern of drug resistance will ensure that the most effective therapy can be selected. The aim of this study is to assess the prevalence and patterns of drug resistance of mycobacterium tuberculosis and to detect the possible risk factors associated with resistant cases.
- Medical subject headings
- Tuberculosis, Extrapulmonary
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of number of cases resistant to Rifampicin and other anti- TB drugs
Using of GeneXpert (MTB/RIF) and Xpert (MTB/XDR) assays to detect resistance to Rifampicin and other anti -TB drugs among TB positive cases
Measured: within 6 months of starting treatment
Secondary outcomes (1)
Detection of common Risk factors associated with resistant cases
collection of (in common) data among cases to detect risk factors associated with drug resistance e.g is drug resistance more common in diabetic patients?, is resistance more common among drug addict patients? , also is there common co-morbid conditions among resistant cases
Measured: within 6 months of starting treatment coarse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary and Extra- Pulmonary Tuberculosis (TB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnia Abdelazim Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169149
- Sponsor's protocol ID
- Soh-Med-25-8---3MD
- Status last verified
- Sep 2025
- First submitted
- 19 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided