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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence and Patterns of Drug Resistance of Mycobacterium Tuberculosis Using GeneXpert (MTB/RIF) and Xpert (MTB/XDR) Assays
- ClinicalTrials.gov ID
- NCT07169149
- Acronym / sponsor ID
- Soh-Med-25-8---3MD
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with geneXpert positive samples whether rifampicin resistant or sensitive
Key inclusion criteria (1 listed)
- geneXpert positive patients in pulmonary and extrapulmonary cases
Key exclusion criteria (1 listed)
- age below 12 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of number of cases resistant to Rifampicin and other anti- TB drugs
Time frame: within 6 months of starting treatment
Using of GeneXpert (MTB/RIF) and Xpert (MTB/XDR) assays to detect resistance to Rifampicin and other anti -TB drugs among TB positive cases
1 secondary outcome
Detection of common Risk factors associated with resistant cases
Time frame: within 6 months of starting treatment coarse
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary and Extra- Pulmonary Tuberculosis (TB)
RecruitingPhase 3
Shortened Regimen for Drug-susceptible TB in Children
Tuberculosis, Tuberculosis, Pulmonary
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary and Extra- Pulmonary Tuberculosis (TB), run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omnia Abdelazeem Zahran (+2 01113328989, omnia_zahran@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of number of cases resistant to Rifampicin and other anti- TB drugs (time frame: within 6 months of starting treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.