TuberculosisNCT06058065
Sensitivity and Specificity of Xpert MTB/RIF Ultra
An observational study of Tuberculosis, run by Assiut University.
Trial summary
To estimate diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for extrapulmonary tuberculosis and rifampicin resistance in adults suspected to be infected with mycobacterium tuberculosis. In addition, this study will estimate the pattern of rifampicin resistance among TB cases in Assiut population. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tuberculosis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 11 Dec 2023to 25 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to Assiut University Hospital with suspected Tuberculosis from July 2023 to June 2024 will be included in the study.
Who may be able to join
- Patients presented to Chest Department with suspected pulmonary or extrapulmonary Tuberculosis will be sequentially included
Who cannot join
- Age: less than 18 years. Patients who received anti tuberculous drugs in the past 6 months. Unstable patients or need for ICU admission
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Value of Xpert® MTB/RIF Ultra in Cases With Suspected Tuberculosis
To estimate diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for extrapulmonary tuberculosis and rifampicin resistance in adults suspected to be infected with mycobacterium tuberculosis. In addition, this study will estimate the pattern of rifampicin resistance among TB cases in Assiut population.
Read the detailed description
Xpert MTB/RIF was introduced recently and added great benefit in management of TB. Xpert MTB/RIF revolutionized the management of Mycobacterium tuberculosis (MTB) infections by providing faster and more accurate MTB diagnosis that detects MTB and rifampicin (RIF) resistance simultaneously. Following World Health Organization (WHO) endorsement in 2010, Xpert MTB/RIF has helped improve TB programs in over 130 countries5.
Building on this success, faster and more accurate detection of MTB from the first point of encounter in the community is critical. Partnered with GeneXpert® Systems, Xpert MTB/RIF Ultra was delivered with the advantages of improved performance and faster time to result (results within 80 minutes). It has higher sensitivity especially in smear-negative TB cases. The processing of the new assay is easy to use and does not need special expertise5. Xpert MTB/RIF Ultra has increased accuracy of Rifampicin results and improved detection of mixed infections. Recently published recommendations by global experts demonstrate the efficiency of using Xpert MTB/RIF Ultra as a frontline test over smear microscopy or line probe assays followed by culture-based methods for drug susceptibility testing. Thus, a single modification of the diagnostic algorithm to detect smear-positive and smear-negative TB patients improves active case management, is more cost-efficient and could potentially reduce the relative rate of transmission. Using Xpert MTB/RIF Ultra has the potential to reduce the number of missed smear-negative TB patients and may lead to a decrease in total costs of patient care due to the detection of MTB in patient specimens and RIF-resistance in a single test. There is great need for further research to assess the diagnostic value of Xpert MTB/RIF Ultra in patients with pulmonary tuberculosis.
- Conditions
- Tuberculosis
- Medical subject headings
- Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Xpert MTB/RIF Ultra
By compare with other test
Measured: Baseline
Secondary outcomes (1)
Prevalence of rifampicin resistance among patients with TB active infection presented to Chest Department in Assiut University Hospital
from results
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start11 Dec 2023 (estimated)
- Primary completion28 Nov 2024 (estimated)
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hend Mohamed Sayed Mohamed, Assiut University
- Investigators
- Mohamed yassen, MD, Study chair, Assiut UniversityAbd-Elmalek Abd-Elmalek, MD, Study chair, Assiut Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058065
- Sponsor's protocol ID
- Ultra Xpert® MTB/RIF
- Status last verified
- Oct 2023
- First submitted
- 22 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kay AW, Ness T, Verkuijl SE, Viney K, Brands A, Masini T, Gonzalez Fernandez L, Eisenhut M, Detjen AK, Mandalakas AM, Steingart KR, Takwoingi Y. Xpert MTB/RIF Ultra assay for tuberculosis disease and rifampicin resistance in children. Cochrane Database Syst Rev. 2022 Sep 6;9(9):CD013359. doi: 10.1002/14651858.CD013359.pub3.
PubMed 36065889Park M, Kon OM. Use of Xpert MTB/RIF and Xpert Ultra in extrapulmonary tuberculosis. Expert Rev Anti Infect Ther. 2021 Jan;19(1):65-77. doi: 10.1080/14787210.2020.1810565. Epub 2020 Sep 24.
PubMed 32806986
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Xpert® MTB/RIF Ultra in Cases With Suspected Tuberculosis
- ClinicalTrials.gov ID
- NCT06058065
- Acronym / sponsor ID
- Ultra Xpert® MTB/RIF
- Conditions
- Tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 11 Dec 2023 (estimated)
- Primary completion
- 28 Nov 2024 (estimated)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 28 Sep 2023 (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.
To estimate diagnostic accuracy of Xpert Ultra and Xpert MTB/RIF for extrapulmonary tuberculosis and rifampicin resistance in adults suspected to be infected with mycobacterium tuberculosis. In addition, this study will estimate the pattern of rifampicin resistance among TB cases in Assiut population.
Detailed description
Xpert MTB/RIF was introduced recently and added great benefit in management of TB. Xpert MTB/RIF revolutionized the management of Mycobacterium tuberculosis (MTB) infections by providing faster and more accurate MTB diagnosis that detects MTB and rifampicin (RIF) resistance simultaneously. Following World Health Organization (WHO) endorsement in 2010, Xpert MTB/RIF has helped improve TB programs in over 130 countries5.
Building on this success, faster and more accurate detection of MTB from the first point of encounter in the community is critical. Partnered with GeneXpert® Systems, Xpert MTB/RIF Ultra was delivered with the advantages of improved performance and faster time to result (results within 80 minutes). It has higher sensitivity especially in smear-negative TB cases. The processing of the new assay is easy to use and does not need special expertise5. Xpert MTB/RIF Ultra has increased accuracy of Rifampicin results and improved detection of mixed infections. Recently published recommendations by global experts demonstrate the efficiency of using Xpert MTB/RIF Ultra as a frontline test over smear microscopy or line probe assays followed by culture-based methods for drug susceptibility testing. Thus, a single modification of the diagnostic algorithm to detect smear-positive and smear-negative TB patients improves active case management, is more cost-efficient and could potentially reduce the relative rate of transmission. Using Xpert MTB/RIF Ultra has the potential to reduce the number of missed smear-negative TB patients and may lead to a decrease in total costs of patient care due to the detection of MTB in patient specimens and RIF-resistance in a single test. There is great need for further research to assess the diagnostic value of Xpert MTB/RIF Ultra in patients with pulmonary tuberculosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to Assiut University Hospital with suspected Tuberculosis from July 2023 to June 2024 will be included in the study.
Key inclusion criteria (1 listed)
- Patients presented to Chest Department with suspected pulmonary or extrapulmonary Tuberculosis will be sequentially included
Key exclusion criteria (1 listed)
- Age: less than 18 years. Patients who received anti tuberculous drugs in the past 6 months. Unstable patients or need for ICU admission
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
Sensitivity and Specificity of Xpert MTB/RIF Ultra
Time frame: Baseline
By compare with other test
1 secondary outcome
Prevalence of rifampicin resistance among patients with TB active infection presented to Chest Department in Assiut University Hospital
Time frame: base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Results publication: PubMed 36065889Kay AW, Ness T, Verkuijl SE, Viney K, Brands A, Masini T, Gonzalez Fernandez L, Eisenhut M, Detjen AK, Mandalakas AM, Steingart KR, Takwoingi Y. Xpert MTB/RIF Ultra assay for tuberculosis disease and rifampicin resistance in children. Cochrane Database Syst Rev. 2022 Sep 6;9(9):CD013359. doi: 10.1002/14651858.CD013359.pub3.
- Results publication: PubMed 32806986Park M, Kon OM. Use of Xpert MTB/RIF and Xpert Ultra in extrapulmonary tuberculosis. Expert Rev Anti Infect Ther. 2021 Jan;19(1):65-77. doi: 10.1080/14787210.2020.1810565. Epub 2020 Sep 24.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mohamed yassen, MD study chair
Assiut University
Abd-Elmalek Abd-Elmalek, MD study chair
Assiut Chest Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hend saleh, MD (01098988712, hend.m.saleh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and Specificity of Xpert MTB/RIF Ultra (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06058065, which also lists 2 linked publications.
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 4 Oct 2023.