Extra Pulmonary TuberculosisNCT03173261
Role of Genexpert in Extra Pulmonary Tuberculosis
A study testing Genexpert in people with Extra Pulmonary Tuberculosis, run by Assiut University.
Trial summary
Diagnosis of extra pulmonary tuberculosis remains especially challenging since the number of Mycobacterium tuberculosis bacilli present in tissues at sites of disease is often low and clinical specimens from deep-seated organs may be difficult to obtain. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Extra Pulmonary Tuberculosis
- What is being tested?
- Genexpert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Sep 2018
- Phase
- Interventional
- 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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients with extra pulmonary tuberculosis
Who cannot join
- Severe co morbid diseases.
- pulmonary tuberculosis
- patients refuse to do genexpert or refusing
Trial locations and contacts
No sites are listed yet.
About this study
Diagnosis of extra pulmonary tuberculosis remains especially challenging since the number of Mycobacterium tuberculosis bacilli present in tissues at sites of disease is often low and clinical specimens from deep-seated organs may be difficult to obtain. Histology is time-consuming to undertake and establishing a diagnosis of tuberculosis with high specificity remains difficult. Tissue microscopy after special staining is often negative and when mycobacteria are seen, it is impossible to distinguish Mycobacterium tuberculosis from non tuberculous mycobacterial disease. Reliance on culture, the mainstay of diagnosis, often leads to considerable delays, compromising patient care and outcomes.
Evidence from 138 studies published before 2008 suggested that nucleic acid amplification technologies could not replace conventional mycobacterial tests (microscopy, culture) for diagnosing pulmonary and, especially, extra pulmonary tuberculosis
Read the detailed description
Only a few years later, GeneXpert technology has changed this paradigm, with a recent systematic review showing pooled sensitivity of 88% and pooled specificity of 98% for diagnosis of pulmonary tuberculosis, but evidence (as of March 2012) for using Xpert MTB/RIF for diagnosing extra pulmonary tuberculosis is still comparatively weak Globally, there is still a dearth of studies involving the use of Xpert MTB/RIF in extra pulmonary tuberculosis specimens, and few provide definitive answers. This is due mostly to the studies having small sample sizes across a range of various specimen types and differences in pre-processing methodologies and in input volumes and to studies having been conducted in different populations (adults, children, Human immunodeficiency virus infected).
- Conditions
- Extra Pulmonary Tuberculosis
- Being tested
- Genexpert
- Medical subject headings
- Tuberculosis, Extrapulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenexpertDiagnostic test
diagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate
| Study group | Role | What they receive |
|---|---|---|
| tuberculous pleural effusion | Other | diagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate Receives: Diagnostic Test: Genexpert |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of positive patients for extra pulmonary tuberculosis
Count of tuberculosis bacilli in the specimen
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionSep 2018 (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 Extra Pulmonary 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lamia saad, Assiut University
- Investigators
- Raafat Talett, Study chair, Assiut UniversityYaser Ahmed, Study chair, Assiut UniversityAhmed Metwally, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173261
- Sponsor's protocol ID
- PTB
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.
PubMed 20825313Lawn SD, Zumla AI. Tuberculosis. Lancet. 2011 Jul 2;378(9785):57-72. doi: 10.1016/S0140-6736(10)62173-3. Epub 2011 Mar 21.
PubMed 21420161
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Genexpert in Extra Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT03173261
- Acronym / sponsor ID
- PTB
- Conditions
- Extra Pulmonary Tuberculosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 1 Jun 2017 (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.
Diagnosis of extra pulmonary tuberculosis remains especially challenging since the number of Mycobacterium tuberculosis bacilli present in tissues at sites of disease is often low and clinical specimens from deep-seated organs may be difficult to obtain. Histology is time-consuming to undertake and establishing a diagnosis of tuberculosis with high specificity remains difficult. Tissue microscopy after special staining is often negative and when mycobacteria are seen, it is impossible to distinguish Mycobacterium tuberculosis from non tuberculous mycobacterial disease. Reliance on culture, the mainstay of diagnosis, often leads to considerable delays, compromising patient care and outcomes.
Evidence from 138 studies published before 2008 suggested that nucleic acid amplification technologies could not replace conventional mycobacterial tests (microscopy, culture) for diagnosing pulmonary and, especially, extra pulmonary tuberculosis
Detailed description
Only a few years later, GeneXpert technology has changed this paradigm, with a recent systematic review showing pooled sensitivity of 88% and pooled specificity of 98% for diagnosis of pulmonary tuberculosis, but evidence (as of March 2012) for using Xpert MTB/RIF for diagnosing extra pulmonary tuberculosis is still comparatively weak Globally, there is still a dearth of studies involving the use of Xpert MTB/RIF in extra pulmonary tuberculosis specimens, and few provide definitive answers. This is due mostly to the studies having small sample sizes across a range of various specimen types and differences in pre-processing methodologies and in input volumes and to studies having been conducted in different populations (adults, children, Human immunodeficiency virus infected).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tuberculous pleural effusion | Other | Diagnostic Test: Genexpertdiagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with extra pulmonary tuberculosis
Key exclusion criteria (3 listed)
- Severe co morbid diseases.
- pulmonary tuberculosis
- patients refuse to do genexpert or refusing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genexpertdiagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate | Diagnostic test | tuberculous pleural effusion |
Primary outcome
the percentage of positive patients for extra pulmonary tuberculosis
Time frame: 10 minutes
Count of tuberculosis bacilli in the specimen
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Background: PubMed 20825313Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.
- Results publication: PubMed 21420161Lawn SD, Zumla AI. Tuberculosis. Lancet. 2011 Jul 2;378(9785):57-72. doi: 10.1016/S0140-6736(10)62173-3. Epub 2011 Mar 21.
- Individual participant dataSharing planned: No
Related trials for Extra Pulmonary Tuberculosis
RecruitingObservational study
Biomarker Analysis for Diagnosing and Treatment Monitoring in Extrapulmonary Tuberculosis Patients in Nairobi, Kenya
Tuberculosis, Extrapulmonary Tuberculosis
RecruitingPhase 2
BPaLMZ for TB Meningitis
Tuberculous Meningitis, HIV
RecruitingObservational study
Diagnostic Utility of Mycobacterium Tuberculosis Cell-free DNA in Hong Kong
Tuberculosis, Pleural, Pleural Biopsy
Not yet recruitingObservational study
MBLA to Differentiate IRIS From Treatment Failure in Extrapulmonary Tuberculosis
Extrapulmonary Tuberculosis
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. This study is not recruiting at the moment.
Raafat Talett study chair
Assiut University
Yaser Ahmed study chair
Assiut University
Ahmed Metwally study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Genexpert in people with Extra Pulmonary 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 3 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 1 Jun 2017. 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 Lamiaa wafie, master (01153715388 ext. 0882130164, lamiasaad079@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of positive patients for extra pulmonary tuberculosis (time frame: 10 minutes). 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 NCT03173261, 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 1 Jun 2017.