TuberculosisERASE-TBNCT04781257
Early Risk Assessment in Household Contacts (≥10 Years) of TB Patients by New Diagnostic Tests in 3 African Countries
An observational study of Tuberculosis, run by Michael Hoelscher at 3 sites in 3 countries.
Trial summary
The ERASE - TB study will be conducted in order to fill a critical unmet need for tuberculosis control. Persons who are in contact with an infectious TB case may become infected themselves. Among those who are infected, most will stay healthy but some will develop TB themselves. Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- New test candidates
- How many people
- 2,100 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Mar 2021to 30 Apr 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: TB index cases will be recruited at the primary health care clinics where the patient is receiving TB treatment. Household contacts have substantial recent exposure to the TB index case in the household (defined as sleeping at least 3/7 nights in the same household in the last 4 weeks).
Who may be able to join
- TB index case:
- Aged at least 18 years
- Having at least one other person living in the household aged ≥10 years
- Written informed consent to conduct socio-economic and clinical questionnaire, to provide a sputum sample for culture and sequencing, and to approach the household members.
- Recently diagnosed with active pulmonary TB within the last 4 weeks
- Has taken less than 7 daily doses of anti-TB treatment since diagnosis; ensuring a positive culture can still be obtained
Show all 14Show fewer
- Able to spontaneously produce sputum
- Sputum microscopy positive in Ziehl-Neelsen or Auramine-O staining of ideally 2+ or higher, but at least 1+ on the IUATLD/WHO scale, OR (in case no sputum microscopy done) GeneXpert positive, at least TB "medium"
- A firm home address, maintained unchanged for the last 6 months, that is accessible to visiting
- Household Contact:
- Aged at least 10 years
- Written informed consent for study participation, including HIV testing, and home visits by the study team for follow-up (for minors <18 yr.: consent of the parent/guardian, assent of the participant)
- Recent (in the last 4 weeks), substantial exposure to an infectious TB case in the household, defined as sleeping at least 3/7 nights in the same household
- If HIV negative: not on preventive therapy (preventive therapy is not an exclusion criterion for HIV positive persons)
Who cannot join
- Household Contact
- Circumstances that raise doubt on free, uncoerced informed consent (e.g. in a mentally handicapped person)
- Prisoners
- Recent treatment for active TB, completed within the last 30 days OR on current TB treatment for active TB.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Mozambique1 site
Instituto Nacional de Saúde (INS) Centro de Investigação e Treino em Saúde da Polana Caniço
Maputo
About this study
Official title: Early Risk Assessment in TB contactS by New Diagnostic tEsts
The ERASE - TB study will be conducted in order to fill a critical unmet need for tuberculosis control. Persons who are in contact with an infectious TB case may become infected themselves. Among those who are infected, most will stay healthy but some will develop TB themselves.
These people would benefit from preventive treatment, which would also stop TB from being spread to other persons.
Read more
The problem currently is that it is impossible to determine with certainty who would require preventive treatment, and who will remain healthy. Out of 100 persons exposed to an infectious TB patient, only 2 will go on to have TB according to a study in Vietnam, but there are no good tests available to identify those with a risk for TB disease. Treating 100 persons to prevent 2 cases of TB is not effective, so preventive treatment is not used in adults and adolescents in Tanzania, Mozambique and Zimbabwe, where this study will be conducted, but also in many other settings.
The ERASE - TB project will evaluate a number of newly developed diagnostic tests, to see which of those will be able to predict TB in persons at risk, and therefore steer preventive treatment well.
For this, the investigators will invite 2,100 household contacts (HHC) of infectious TB patients, who are at least 10 years old, into the study. Everyone will be examined initially, and again in regular intervals, for 1.5 to 2 years; and whenever the participants will present with symptoms that could indicate that they develop TB.
At every visit, the investigators will perform an X-ray and take some blood and urine samples to perform new candidate tests. At the first/baseline visit, all household contacts without TB will undergo a spirometry to evaluate their pulmonary function.
If someone is unwell, the investigators will also examine sputum for the presence of TB bacilli. In the end, the investigators will then be able to say who of the persons in the study developed TB, and who remained healthy. From all samples taken at different timepoints, the investigators will then determine which test found TB early, and clearly distinguished between persons developing TB, and persons who would remain healthy .
- Conditions
- Tuberculosis
- Being tested
- New test candidates
- Keywords
- Tuberculosis, Latent Tuberculosis, Pulmonary Tuberculosis, Case-Control Studies, Disease Transmission, Infectious, Blood Specimen Collection, Urine Specimen Collection, Sputum, Diagnostic Techniques and Procedures, Biomarkers, Interferon-gamma Release Tests, Mass Chest X-ray, Radiography, Respiratory Function Tests, Spirometry, Artificial Intelligence, Transcriptome, Biological Specimen Banks, Models, Theoretical, Housing
- Medical subject headings
- Tuberculosis, Latent Tuberculosis, Tuberculosis, Pulmonary, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New test candidatesDiagnostic test
The following new diagnostic tests will be done after the completion of the study with the samples (blood, sputum, urine) and data (digital X-ray) obtained during the study period:
CAD4TB / qXR Xpert Ultra® FLOW-TB TAM-TB 4RISK and COR Cepheid 3-gene signature cartridge BioMérieux ISIT TB blood transcription signature assay Multiplex LSHTM in-house host biomarker assay TB Screen biosignature SeroSelect
Retrospective testing of participants' samples and data acquired during the study period, differentiated between participants with co-prevalent/incipient TB and participants staying health throughout the trial
| Study group | Role | What they receive |
|---|---|---|
| Household contacts with co-prevalent/incipient TB | Household contacts diagnosed with active TB at baseline/during the study period Receives: Diagnostic Test: New test candidates | |
| Household contacts staying healthy | Household contacts without active TB who remain healthy throughout the study Receives: Diagnostic Test: New test candidates |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of new diagnostics to diagnose co-prevalent TB against a clinica/microbiological reference standard case definition
to determine sensitivity and specificity of new diagnostics for diagnosing TB earlier with a special focus on subclinical disease.
New diagnostics will be evaluated against a reference standard for classification of presence of, or development of TB disease in a person exposed to a source case; with the following possibilities:
- Co--prevalent symptomatic TB
- Co--prevalent subclinical TB
- Minimal TB, with incident TB during follow-up
- Remained healthy
Measured: Co-prevalent TB disease can be diagnosed at Baseline (Month 0)
Evaluation of novel diagnostics for detection of developing, minimal TB against a clinica/microbiological reference standard case definition
to evaluate novel diagnostics for detection of developing, minimal TB that would cause infectious disease in the future.
For reference standard case classification, see 1.
Measured: TB disease can be diagnosed through study completion, up to Month 24
Enhancement of diagnostic performance by simulating testing algorithms coupled with a risk estimate from a mathematical model
to enhance diagnostic performance by simulating testing algorithms coupled with a risk estimate from a mathematical model For reference standard case classification, see 1.
Measured: TB disease can be diagnosed through study completion, up to Month 24
Secondary outcomes (3)
M.tb infection status as measured by an immunological assay
M.tb infection status as measured by an immunological assay:
- M.tb infected at baseline
- M.tb uninfected at baseline through to end of study
- Change of M.tb infection status from negative (baseline) to positive during follow-up
Measured: through study completion, up to Month 24
Classification of cases of co-prevalent or incident TB; through M.tb isolate sequencing and comparison with the source case isolate
Classification of cases of co-prevalent or incident TB; through M.tb isolate sequencing and comparison with the source case isolate:
- Secondary, infected by source case - defined timepoint of infection
- Other, unknown source of infection - unknown timepoint of infection
Measured: through study completion, up to Month 24
Assessment of the proportion of HHC (without co-prevalent TB) with abnormal pulmonary function at baseline
to assess the proportion of HHC (without co-prevalent TB) with abnormal pulmonary function at baseline, the type and severity of impairments, the relationship between pre-existing abnormal pulmonary function and incident TB (and the changes in pulmonary function measured by spirometry after incident TB and TB treatment completion).
Measured: Spirometry will be done only at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Mar 2021
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Hoelscher
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Sponsor-investigator, Michael Hoelscher, Ludwig-Maximilians - University of Munich
- Investigators
- Theodora Mbunda, MD, PhD, Principal investigator, National Institute of Medical Research - Mbeya Medical Research CentreDenise F Banze, MD, Principal investigator, Instituto Nacional de Saúde (INS)Junior Mutsvangwa, MD, Principal investigator, Biomedical Research & Training Institute (BRTI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781257
- Sponsor's protocol ID
- LMU-IMPH-AIDA-03
- Acronym
- ERASE-TB
- Status last verified
- Nov 2023
- First submitted
- 21 Dec 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Accordance with EU General Data Protection Regulation and local data protection law needs to be worked out.
Publications
Drain PK, Bajema KL, Dowdy D, Dheda K, Naidoo K, Schumacher SG, Ma S, Meermeier E, Lewinsohn DM, Sherman DR. Incipient and Subclinical Tuberculosis: a Clinical Review of Early Stages and Progression of Infection. Clin Microbiol Rev. 2018 Jul 18;31(4):e00021-18. doi: 10.1128/CMR.00021-18. Print 2018 Oct.
PubMed 30021818Fox GJ, Nhung NV, Sy DN, Hoa NLP, Anh LTN, Anh NT, Hoa NB, Dung NH, Buu TN, Loi NT, Nhung LT, Hung NV, Lieu PT, Cuong NK, Cuong PD, Bestrashniy J, Britton WJ, Marks GB. Household-Contact Investigation for Detection of Tuberculosis in Vietnam. N Engl J Med. 2018 Jan 18;378(3):221-229. doi: 10.1056/NEJMoa1700209.
PubMed 29342390Swindells S, Ramchandani R, Gupta A, Benson CA, Leon-Cruz J, Mwelase N, Jean Juste MA, Lama JR, Valencia J, Omoz-Oarhe A, Supparatpinyo K, Masheto G, Mohapi L, da Silva Escada RO, Mawlana S, Banda P, Severe P, Hakim J, Kanyama C, Langat D, Moran L, Andersen J, Fletcher CV, Nuermberger E, Chaisson RE; BRIEF TB/A5279 Study Team. One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis. N Engl J Med. 2019 Mar 14;380(11):1001-1011. doi: 10.1056/NEJMoa1806808.
PubMed 30865794Larsson L, Olaru ID, Behnke AL, Marambire ET, Chipinduro M, Calderwood CJ, Banze D, Mfinanga A, Nhamuave C, Mwambola HL, Held K, Gupta RK, Minja LT, Khosa C, Heinrich N, Kranzer K; ERASE-TB consortium. Diagnostic and prognostic accuracy of the Mycobacterium tuberculosis host response 3-gene cartridge among tuberculosis household contacts in Mozambique, Tanzania, and Zimbabwe: a prospective, longitudinal, diagnostic and prognostic accuracy cohort study. Lancet Infect Dis. 2026 Aug;26(8):858-870. doi: 10.1016/S1473-3099(26)00114-3. Epub 2026 Apr 20.
PubMed 42026013Marambire ET, Banze D, Mfinanga A, Mutsvangwa J, Mbunda TD, Ntinginya NE, Celso K, Kallenius G, Calderwood CJ, Geldmacher C, Held K, Appalarowthu T, Riess F, Panzner U, Heinrich N, Kranzer K; ERASE-TB Consortium. Early risk assessment in paediatric and adult household contacts of confirmed tuberculosis cases by novel diagnostic tests (ERASE-TB): protocol for a prospective, non-interventional, longitudinal, multicountry cohort study. BMJ Open. 2022 Jul 19;12(7):e060985. doi: 10.1136/bmjopen-2022-060985.
PubMed 36427173
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Risk Assessment in TB contactS by New Diagnostic tEsts
- ClinicalTrials.gov ID
- NCT04781257
- Acronym / sponsor ID
- ERASE-TB / LMU-IMPH-AIDA-03
- Conditions
- Tuberculosis
- Keywords
- Tuberculosis, Latent Tuberculosis, Pulmonary Tuberculosis, Case-Control Studies, Disease Transmission, Infectious, Blood Specimen Collection, Urine Specimen Collection, Sputum
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,100 participants (estimated)
- Lead sponsor
- Michael HoelscherUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 4 Mar 2021 (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.
The ERASE - TB study will be conducted in order to fill a critical unmet need for tuberculosis control. Persons who are in contact with an infectious TB case may become infected themselves. Among those who are infected, most will stay healthy but some will develop TB themselves.
These people would benefit from preventive treatment, which would also stop TB from being spread to other persons.
The problem currently is that it is impossible to determine with certainty who would require preventive treatment, and who will remain healthy. Out of 100 persons exposed to an infectious TB patient, only 2 will go on to have TB according to a study in Vietnam, but there are no good tests available to identify those with a risk for TB disease. Treating 100 persons to prevent 2 cases of TB is not effective, so preventive treatment is not used in adults and adolescents in Tanzania, Mozambique and Zimbabwe, where this study will be conducted, but also in many other settings.
The ERASE - TB project will evaluate a number of newly developed diagnostic tests, to see which of those will be able to predict TB in persons at risk, and therefore steer preventive treatment well.
For this, the investigators will invite 2,100 household contacts (HHC) of infectious TB patients, who are at least 10 years old, into the study. Everyone will be examined initially, and again in regular intervals, for 1.5 to 2 years; and whenever the participants will present with symptoms that could indicate that they develop TB.
At every visit, the investigators will perform an X-ray and take some blood and urine samples to perform new candidate tests. At the first/baseline visit, all household contacts without TB will undergo a spirometry to evaluate their pulmonary function.
If someone is unwell, the investigators will also examine sputum for the presence of TB bacilli. In the end, the investigators will then be able to say who of the persons in the study developed TB, and who remained healthy. From all samples taken at different timepoints, the investigators will then determine which test found TB early, and clearly distinguished between persons developing TB, and persons who would remain healthy .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Household contacts with co-prevalent/incipient TB | – | Diagnostic Test: New test candidatesHousehold contacts diagnosed with active TB at baseline/during the study period |
| Household contacts staying healthy | – | Diagnostic Test: New test candidatesHousehold contacts without active TB who remain healthy throughout the study |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- TB index cases will be recruited at the primary health care clinics where the patient is receiving TB treatment. Household contacts have substantial recent exposure to the TB index case in the household (defined as sleeping at least 3/7 nights in the same household in the last 4 weeks).
Key inclusion criteria (14 listed)
- Aged at least 18 years
- Having at least one other person living in the household aged ≥10 years
- Written informed consent to conduct socio-economic and clinical questionnaire, to provide a sputum sample for culture and sequencing, and to approach the household members.
- Recently diagnosed with active pulmonary TB within the last 4 weeks
- Has taken less than 7 daily doses of anti-TB treatment since diagnosis; ensuring a positive culture can still be obtained
Key exclusion criteria (4 listed)
- Household Contact
- Circumstances that raise doubt on free, uncoerced informed consent (e.g. in a mentally handicapped person)
- Prisoners
- Recent treatment for active TB, completed within the last 30 days OR on current TB treatment for active TB.
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 |
|---|---|---|
| New test candidatesThe following new diagnostic tests will be done after the completion of the study with the samples (blood, sputum, urine) and data (digital X-ray) obtained during the study period: CAD4TB / qXR Xpert Ultra® FLOW-TB TAM-TB 4RISK and COR Cepheid 3-gene signature cartridge BioMérieux ISIT TB blood transcription signature assay Multiplex LSHTM in-house host biomarker assay TB Screen biosignature SeroSelect Retrospective testing of participants' samples and data acquired during the study period, differentiated between participants with co-prevalent/incipient TB and participants staying health throughout the trial | Diagnostic test | Household contacts staying healthy, Household contacts with co-prevalent/incipient TB |
Primary outcome
Sensitivity and specificity of new diagnostics to diagnose co-prevalent TB against a clinica/microbiological reference standard case definition
Time frame: Co-prevalent TB disease can be diagnosed at Baseline (Month 0)
to determine sensitivity and specificity of new diagnostics for diagnosing TB earlier with a special focus on subclinical disease. New diagnostics will be evaluated against a reference standard for classification of presence of, or development of TB disease in a person exposed to a source case; with the following possibilities: * Co--prevalent symptomatic TB * Co--prevalent subclinical TB * Minimal TB, with incident TB during follow-up * Remained healthy
Evaluation of novel diagnostics for detection of developing, minimal TB against a clinica/microbiological reference standard case definition
Time frame: TB disease can be diagnosed through study completion, up to Month 24
to evaluate novel diagnostics for detection of developing, minimal TB that would cause infectious disease in the future. For reference standard case classification, see 1.
Enhancement of diagnostic performance by simulating testing algorithms coupled with a risk estimate from a mathematical model
Time frame: TB disease can be diagnosed through study completion, up to Month 24
to enhance diagnostic performance by simulating testing algorithms coupled with a risk estimate from a mathematical model For reference standard case classification, see 1.
3 secondary outcomes
M.tb infection status as measured by an immunological assay
Time frame: through study completion, up to Month 24
Classification of cases of co-prevalent or incident TB; through M.tb isolate sequencing and comparison with the source case isolate
Time frame: through study completion, up to Month 24
Assessment of the proportion of HHC (without co-prevalent TB) with abnormal pulmonary function at baseline
Time frame: Spirometry will be done only at baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 30021818Drain PK, Bajema KL, Dowdy D, Dheda K, Naidoo K, Schumacher SG, Ma S, Meermeier E, Lewinsohn DM, Sherman DR. Incipient and Subclinical Tuberculosis: a Clinical Review of Early Stages and Progression of Infection. Clin Microbiol Rev. 2018 Jul 18;31(4):e00021-18. doi: 10.1128/CMR.00021-18. Print 2018 Oct.
- Background: PubMed 29342390Fox GJ, Nhung NV, Sy DN, Hoa NLP, Anh LTN, Anh NT, Hoa NB, Dung NH, Buu TN, Loi NT, Nhung LT, Hung NV, Lieu PT, Cuong NK, Cuong PD, Bestrashniy J, Britton WJ, Marks GB. Household-Contact Investigation for Detection of Tuberculosis in Vietnam. N Engl J Med. 2018 Jan 18;378(3):221-229. doi: 10.1056/NEJMoa1700209.
- Background: PubMed 30865794Swindells S, Ramchandani R, Gupta A, Benson CA, Leon-Cruz J, Mwelase N, Jean Juste MA, Lama JR, Valencia J, Omoz-Oarhe A, Supparatpinyo K, Masheto G, Mohapi L, da Silva Escada RO, Mawlana S, Banda P, Severe P, Hakim J, Kanyama C, Langat D, Moran L, Andersen J, Fletcher CV, Nuermberger E, Chaisson RE; BRIEF TB/A5279 Study Team. One Month of Rifapentine plus Isoniazid to Prevent HIV-Related Tuberculosis. N Engl J Med. 2019 Mar 14;380(11):1001-1011. doi: 10.1056/NEJMoa1806808.
- Derived from this study: PubMed 42026013Larsson L, Olaru ID, Behnke AL, Marambire ET, Chipinduro M, Calderwood CJ, Banze D, Mfinanga A, Nhamuave C, Mwambola HL, Held K, Gupta RK, Minja LT, Khosa C, Heinrich N, Kranzer K; ERASE-TB consortium. Diagnostic and prognostic accuracy of the Mycobacterium tuberculosis host response 3-gene cartridge among tuberculosis household contacts in Mozambique, Tanzania, and Zimbabwe: a prospective, longitudinal, diagnostic and prognostic accuracy cohort study. Lancet Infect Dis. 2026 Aug;26(8):858-870. doi: 10.1016/S1473-3099(26)00114-3. Epub 2026 Apr 20.
- Derived from this study: PubMed 36427173Marambire ET, Banze D, Mfinanga A, Mutsvangwa J, Mbunda TD, Ntinginya NE, Celso K, Kallenius G, Calderwood CJ, Geldmacher C, Held K, Appalarowthu T, Riess F, Panzner U, Heinrich N, Kranzer K; ERASE-TB Consortium. Early risk assessment in paediatric and adult household contacts of confirmed tuberculosis cases by novel diagnostic tests (ERASE-TB): protocol for a prospective, non-interventional, longitudinal, multicountry cohort study. BMJ Open. 2022 Jul 19;12(7):e060985. doi: 10.1136/bmjopen-2022-060985.
- WHO Global Tuberculosis Report 2019Link provided by the sponsor.
- Consensus Meeting Report: Development of a Target Product Profile (TPP) and a framework for evaluation for a test for predicting progression from tuberculosis infection to active diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Accordance with EU General Data Protection Regulation and local data protection law needs to be worked out.
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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.
Theodora Mbunda, MD, PhD principal investigator
National Institute of Medical Research - Mbeya Medical Research Centre
Denise F Banze, MD principal investigator
Instituto Nacional de Saúde (INS)
Junior Mutsvangwa, MD principal investigator
Biomedical Research & Training Institute (BRTI)
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, run by Michael Hoelscher at 3 sites in 3 countries.
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 14 inclusion and 4 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 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Mozambique, Tanzania, Zimbabwe. 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?
Results are not available in the source record.
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?
Sensitivity and specificity of new diagnostics to diagnose co-prevalent TB against a clinica/microbiological reference standard case definition (time frame: Co-prevalent TB disease can be diagnosed at Baseline (Month 0)). The study lists 3 primary outcomes in all. 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 NCT04781257, which also lists 5 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 28 Nov 2023.