TuberculosisPROVE-TBNCT04583904
Prospective Evaluation of Novel Diagnostics for Tuberculosis in KwaZulu-Natal, South Africa
An observational study of Tuberculosis, run by University of Washington at 1 site in South Africa.
Trial summary
Tuberculosis (TB) infects nearly two billion people and has become the leading infectious cause of mortality worldwide, due in part to inadequate diagnostic and prognostic tests. Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Tuberculosis
- How many people
- 843 participants
- Where
- 1 siteSouth Africa
- Study dates
- 18 Sep 2019to 31 Aug 2022
- 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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study may enroll 3 different types of patient cohorts, including (1) hospitalized adults (≥16 years old), (2) ambulatory adults (≥16 years old) in outpatient clinics, and (3) children <12 years suspected of having active TB disease.
Phase I
- Eligibility for hospitalized and ambulatory adults:
- ≥16 years old
- Positive Xpert MTB/RIF Ultra test (TB-positive cohort) or no suspicion of clinical TB (TB-negative cohort)
- Have a documented HIV test result or agrees to test for HIV
- Have NOT received IPT within prior 3 months
- Have NOT received anti-TB treatment for more than 24 hours
- Willing/able to provide written informed consent
Phase II:
- Eligibility for hospitalized adults:
- ≥16 years old
- Admitted to inpatient medical ward <72 hours
- Have a documented positive HIV test
- Have NOT received IPT within prior 3 months
- Have NOT received anti-TB treatment for more than 24 hours
- Willing/able to provide written informed consent Study population description:
- Eligibility for Xpert+ adults (hospitalized and attending outpatient clinics)
- ≥16 years old
- Have a documented HIV test result or agrees to test for HIV
- Positive Xpert MDR/RIF Ultra test documented.
- Have NOT received anti-TB treatment for more than 24 hours
- Willing/able to provide written informed consent
- Eligibility for children
- children <12 years of age
- suspected of having active TB disease by clinical team
- Have a documented HIV test result or agrees to test for HIV
- Have not had IPT within 3 months
- Have not received anti-TB treatment for more than 24 hours within the prior 5 days
- Parent or guardian is willing/able to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Tuberculosis (TB) infects nearly two billion people and has become the leading infectious cause of mortality worldwide, due in part to inadequate diagnostic and prognostic tests. Older diagnostic tools, such as acid-fast staining, and newer diagnostic tests, such as nucleic acid amplification, are either insensitive, expensive, or not suitable for use at the clinical point-of-care. Therefore, novel diagnostic tests are needed to diagnose active TB disease among adults, people living with HIV (PLHIV), and children in TB-endemic countries. In this project, the investigators will conduct clinical evaluation studies of emerging TB diagnostic tests among (1) hospitalized adults, (2) ambulatory adults in outpatient clinics, and (3) children <12 years suspected of having active TB disease. the investigators will also maintain a biorepository of well-characterized clinical specimens that can be used for either retrospective validation of TB diagnostic tests, establishing a reference LAM test, or to share with partners developing novel TB diagnostics, including new LAM antibodies. The project will be coordinated at the University of Washington, and conducted in partnership with clinical research partners in South Africa, including Umkhuseli Innovation and Research Management (UIRM) and the National Health Laboratory Service (NHLS). The project team is well-equipped to serve as a central clinical research site to evaluate new and emerging point-of-care TB diagnostics, particularly novel urinary LAM assays, at the on-site TB Diagnostics Research Laboratory at Edendale Hospital in KwaZulu-Natal, South Africa.
- Conditions
- Tuberculosis
- Keywords
- Urine-Lam, Diagnostics
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults - inpatient | Not described | |
| Adults- ambulatory | Not described | |
| Children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Classified with TB Case Definition
TB positive: A person with a positive Xpert MTB/RIF test or TB culture on any bodily fluid specimen that was obtained/tested within 5 days of enrollment.
Probable TB: A person with compatible symptoms, signs, histopathological specimens and imaging for TB, but without a positive TB culture or Xpert test on any specimen; empirically initiated on TB treatment.
TB negative: A person with a primary hospital diagnosis other than TB, who has no clinical suspicion for TB, and no diagnostic TB testing ordered by the treating team.
TB negative (TB excluded): A person with all reference microbiological testing for TB returning negative, including negative Xpert, negative TB culture, other investigations for TB negative (e.g. histopathology, imaging) and either clinical improvement in the absence of anti-TB therapy or alternate diagnosis determined. In addition, no incident TB diagnosis made (including empiric anti-TB treatment initiation) within the 2 months following enrollment.
Measured: Baseline
Secondary outcomes (1)
Number of Participants with TB Treatment Outcome
- Confirmed TB: Bacteriological confirmation obtained: culture or Xpert MTB/RIF from at least one specimen.
- Probable TB: Bacteriological confirmation not obtained AND at least 2 of the following:
- Symptoms/signs suggestive of TB (as defined)
- Chest radiograph or abdominal ultrasound consistent with TB
- Close TB exposure or immunologic evidence of M. tuberculosis infection
- Positive response to anti-TB treatment (requires documented positive clinical response on TB treatment)
- TB negative/unlikely: Bacteriological confirmation NOT obtained AND criteria for "unconfirmed tuberculosis" NOT met.
Measured: 2 Month, 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start18 Sep 2019
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 843 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Umkhuseli Innovation and Research Management (UIRM), University of KwaZulu, PATH, KwaZulu Natal Department of Health, Salus Ltd.
- Responsible party
- Principal investigator, Paul Drain, University of Washington
- Investigators
- Paul K. Drain, MD, MPH, FACP, Principal investigator, University of WashingtonDouglas Wilson, MD, Principal investigator, University of KwaZulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583904
- Sponsor's protocol ID
- STUDY00009092
- Other IDs
- OPP1213504
- Acronym
- PROVE-TB
- Status last verified
- Aug 2024
- First submitted
- 29 Sep 2020
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Novel Diagnostics for Tuberculosis in KwaZulu-Natal, South Africa
- ClinicalTrials.gov ID
- NCT04583904
- Acronym / sponsor ID
- PROVE-TB / STUDY00009092
- Conditions
- Tuberculosis
- Keywords
- Urine-Lam, Diagnostics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 843 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Umkhuseli Innovation and Research Management (UIRM), University of KwaZulu, PATH, KwaZulu Natal Department of Health, Salus Ltd.
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 12 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) infects nearly two billion people and has become the leading infectious cause of mortality worldwide, due in part to inadequate diagnostic and prognostic tests. Older diagnostic tools, such as acid-fast staining, and newer diagnostic tests, such as nucleic acid amplification, are either insensitive, expensive, or not suitable for use at the clinical point-of-care. Therefore, novel diagnostic tests are needed to diagnose active TB disease among adults, people living with HIV (PLHIV), and children in TB-endemic countries. In this project, the investigators will conduct clinical evaluation studies of emerging TB diagnostic tests among (1) hospitalized adults, (2) ambulatory adults in outpatient clinics, and (3) children <12 years suspected of having active TB disease. the investigators will also maintain a biorepository of well-characterized clinical specimens that can be used for either retrospective validation of TB diagnostic tests, establishing a reference LAM test, or to share with partners developing novel TB diagnostics, including new LAM antibodies. The project will be coordinated at the University of Washington, and conducted in partnership with clinical research partners in South Africa, including Umkhuseli Innovation and Research Management (UIRM) and the National Health Laboratory Service (NHLS). The project team is well-equipped to serve as a central clinical research site to evaluate new and emerging point-of-care TB diagnostics, particularly novel urinary LAM assays, at the on-site TB Diagnostics Research Laboratory at Edendale Hospital in KwaZulu-Natal, South Africa.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adults - inpatient | – | – |
| Adults- ambulatory | – | – |
| Children | – | – |
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study may enroll 3 different types of patient cohorts, including (1) hospitalized adults (≥16 years old), (2) ambulatory adults (≥16 years old) in outpatient clinics, and (3) children <12 years suspected of having active TB disease.
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
Number of Participants Classified with TB Case Definition
Time frame: Baseline
TB positive: A person with a positive Xpert MTB/RIF test or TB culture on any bodily fluid specimen that was obtained/tested within 5 days of enrollment. Probable TB: A person with compatible symptoms, signs, histopathological specimens and imaging for TB, but without a positive TB culture or Xpert test on any specimen; empirically initiated on TB treatment. TB negative: A person with a primary hospital diagnosis other than TB, who has no clinical suspicion for TB, and no diagnostic TB testing ordered by the treating team. TB negative (TB excluded): A person with all reference microbiological testing for TB returning negative, including negative Xpert, negative TB culture, other investigations for TB negative (e.g. histopathology, imaging) and either clinical improvement in the absence of anti-TB therapy or alternate diagnosis determined. In addition, no incident TB diagnosis made (including empiric anti-TB treatment initiation) within the 2 months following enrollment.
1 secondary outcome
Number of Participants with TB Treatment Outcome
Time frame: 2 Month, 6 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Paul K. Drain, MD, MPH, FACP principal investigator
University of Washington
Douglas Wilson, MD principal investigator
University of KwaZulu
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 Tuberculosis, run by University of Washington at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: finished, as of the sponsor's last update on 7 Aug 2024. 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 South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Classified with TB Case Definition (time frame: Baseline). 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 7 Aug 2024.