HIV InfectionsNCT04600232
TB-LAM in the Diagnosis of TB
A study testing Alere TB-LAM in people with HIV Infections and Tuberculosis, run by Shanghai Public Health Clinical Center.
Trial summary
Tuberculosis (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients. Urine based detection of lipoarabinomannan (LAM) provides promising methods for quick diagnosis of TB in HIV-infected patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HIV Infections, Tuberculosis, Non-Tuberculous Mycobacterial Pneumonia
- What is being tested?
- Alere TB-LAM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Feb 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitalized HIV-infected patients.
- Willing to participate into the study.
Who cannot join
- Already diagnosed with active TB
- Received any anti-tuberculosis drugs and/or quinolone for more than 7 days.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Utility of TB-LAM in the Diagnosis of Active TB in Hospitalized HIV-infected Patients
Tuberculosis (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients. Urine based detection of lipoarabinomannan (LAM) provides promising methods for quick diagnosis of TB in HIV-infected patients. However, the sensitivity and specificity of TB-LAM is still not well established, especially in area where non-tuberculosis mycobacterium is also prevalence. Here we aimed to evaluate the clinical utility of TB-LAM in diagnosis of active TB in hospitalized HIV-infected patients.
- Being tested
- Alere TB-LAM
- Medical subject headings
- HIV Infections, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alere TB-LAMDiagnostic test
Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis arm | Experimental | Urine TB-LAM, sputum smear, Gene Xpert, mycobacterial culture Receives: Diagnostic Test: Alere TB-LAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity against microbiological reference standard
Number of TB-LAM positive/Number of positive by culture or Gene Xpert
Measured: 2 months
Specificity against microbiological reference standard
1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear
Measured: 2 months
Secondary outcomes (2)
Sensitivity against composite reference standard
Number of TB-LAM positive/Number of active TB diagnosed clinically
Measured: 2 months
Specificity against composite reference standard
1-Number of TB-LAM negative/Number of TB excluded
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Public Health Clinical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jun Chen, Shanghai Public Health Clinical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600232
- Sponsor's protocol ID
- TB-LAM
- Status last verified
- Oct 2020
- First submitted
- 20 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant data without individual identification can be provided upon request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Utility of TB-LAM in the Diagnosis of Active TB in Hospitalized HIV-infected Patients
- ClinicalTrials.gov ID
- NCT04600232
- Acronym / sponsor ID
- TB-LAM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Public Health Clinical CenterOther government
- Study start
- Oct 2020 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 23 Oct 2020 (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 (TB) is still the leading cause of death in HIV-infected patients. Early diagnosis of TB substantially improves the survival of HIV-infected patients. Urine based detection of lipoarabinomannan (LAM) provides promising methods for quick diagnosis of TB in HIV-infected patients. However, the sensitivity and specificity of TB-LAM is still not well established, especially in area where non-tuberculosis mycobacterium is also prevalence. Here we aimed to evaluate the clinical utility of TB-LAM in diagnosis of active TB in hospitalized HIV-infected patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis arm | Experimental | Diagnostic Test: Alere TB-LAMUrine TB-LAM, sputum smear, Gene Xpert, mycobacterial culture |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized HIV-infected patients.
- Willing to participate into the study.
Key exclusion criteria (2 listed)
- Already diagnosed with active TB
- Received any anti-tuberculosis drugs and/or quinolone for more than 7 days.
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 |
|---|---|---|
| Alere TB-LAMSubjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture. | Diagnostic test | Diagnosis arm |
Primary outcome
Sensitivity against microbiological reference standard
Time frame: 2 months
Number of TB-LAM positive/Number of positive by culture or Gene Xpert
Specificity against microbiological reference standard
Time frame: 2 months
1-Number of TB-LAM negative/Number of negative by culture or Gene Xpert or smear
2 secondary outcomes
Sensitivity against composite reference standard
Time frame: 2 months
Specificity against composite reference standard
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No. Participant data without individual identification can be provided upon request.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Alere TB-LAM in people with HIV Infections and Tuberculosis, run by Shanghai Public Health Clinical Center.
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 2 inclusion and 2 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 23 Oct 2020. 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 Jun Chen, M.D (+86-21-37990333 ext. 3222, qtchenjun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity against microbiological reference standard (time frame: 2 months). The study lists 2 primary outcomes in all. 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 23 Oct 2020.