TuberculosisMLWBCGCHIMNCT06178666
A Controlled Human Infection Model (CHIM) With Intradermal BCG in Malawi
A study testing BCG in people with Tuberculosis, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial summary
Despite tremendous efforts, an effective tuberculosis (TB) vaccine remains elusive. TB continues to infect and kill many. In 2021, TB infected more than 10 million and killed 1.6 million people. To date, the M.bovis bacille Calmette Guerin (BCG) is the only licensed vaccine against tuberculosis (TB). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- BCG
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteMalawi
- Study dates
- 1 Mar 2024to 1 Mar 2026
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults aged 18-50 (inclusive)
- Resident near QECH, Blantyre (\<1 hour drive) for the duration of the study period
- Allows the investigators to review the volunteer's medical history in the health passport book.
- Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate birth control measures during the study.
- Fluent spoken English or Chichewa - to ensure a comprehensive understanding of the research project and their proposed involvement.
- Capacity to provide informed consent before joining the study.
- Able and willing (in the investigators opinion) to comply with all the study requirements.
Who cannot join
- Laboratory evidence at screening of subclinical M. tb infection as indicated by a positive ELISPOT response to ESAT-6 or CFP-10 antigens. Volunteers discovered to have evidence of latent M. tb infection as defined by a positive ELISPOT test will be referred to the chest clinic for investigation for tuberculosis according to Malawi standard protocols.
- Clinical, radiological, or laboratory evidence of current active TB disease
- Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, or psychiatric disorder.
- Current medical issues. Volunteers who are excluded from the study because they have been discovered to have a previously undiagnosed condition thought to require further medical attention will be referred appropriately to QECH specialist services for further investigation and treatment.
- Acute respiratory tract infection in the four weeks preceding recruitment
- Any uncontrolled medical or surgical condition at the discretion of the study doctor
Show all 22Show fewer
- Female participants who are pregnant, or intending to become pregnant, lactating or who Female participants who are unable to take contraception measures during the study.
- Smoking: Current (defined as ≥5/week) or ex-smoker (cigarettes / cigars / smoking of recreational drugs) in the last 6 months. Previous significant smoking history (more than 20 cigarettes per day for 20 years or the equivalent [\>20 pack years]).Current alcohol and recreational drug use
- Regularly drinks ≥3units/day (male) or ≥2units/day (female)
- Uses recreational drugs.
- Participants may be excluded at the discretion of the research clinician.
- Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents
- History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the challenge agent.
- Has received any vaccination within one month of screening visit.
- Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the volunteer in the study.
- Current involvement in another trial that involves regular blood tests or an investigational medicinal product.
- Use of an investigational medicinal product or non-registered drug, live vaccine, or investigational medical device for four weeks prior to dosing with the study challenge agent
- Participants who meet STOP criteria at the time of screening (see table 4)
- Any other issue which, in the opinion of the study staff, may
- Put the participant or their contacts at risk because of participation in the study,
- Adversely affect the interpretation of the study results, or
- Impair the participant's ability to participate in the study.
Trial locations and contacts
1 site in 1 country.
Malawi1 site
Queen Elizabeth Central Hospital
Blantyre, BT3
Neema Toto, SRN MRes, 265992892182, ntoto@mlw.mw
Maureen Mkutumula, +265992552382, mmkutumula@mlw.mw
About this study
Official title: A Feasibility Study of a Controlled Human Infection Model (CHIM) With Intradermal Bacillus Calmette-Guérin (BCG) Injection in Malawi
Despite tremendous efforts, an effective tuberculosis (TB) vaccine remains elusive. TB continues to infect and kill many. In 2021, TB infected more than 10 million and killed 1.6 million people. To date, the M.bovis bacille Calmette Guerin (BCG) is the only licensed vaccine against tuberculosis (TB). Efforts to come up with new and effective vaccines have not been successful. Partially, the lack of suitable disease models and protection correlates hinders the research of new vaccines. Controlled human infection model studies (CHIM) involve administering disease-causing microbes to healthy individuals, with continued monitoring of disease response. These studies have been used to study malaria, typhoid, pneumococcal pneumonia and the recent SARS-CoV-2 vaccines. The BCG-Controlled Human Infection Model (BCG-CHIM) will allow accurate dosing with safe mycobacteria as well as minimal tissue sampling to understand immunity to mycobacteria. Considering that the M. bovis BCG is a safe living Mycobacteria, it can be used as a CHIM against which to test new vaccines.
Read the detailed description
Tuberculosis (TB) is a leading cause of death from a single infectious agent worldwide and is an acknowledged major challenge in Malawi. Globally in 2021, there were an estimated 10.6 million people unwell with TB and an estimated 1.6 million deaths caused by TB. Furthermore, the global TB incidence could be accelerated to an average of 17% per year between 2025 and 2035 owing to the disruption to TB services caused by the COVID pandemic. TB diagnosis is challenging, and drug treatment can be prolonged, harmful, costly, and complex, especially in the increasingly common context of drug resistant M. tuberculosis. For these reasons an effective vaccine to prevent disease is a global public health priority, and drugs to allow shorter courses of effective therapy are urgently needed.
At present, the only licensed vaccine is the bacille Calmette-Guérin (BCG) vaccine (BCG Bulgaria is the Malawi licensed strain). BCG has been administered globally to several billion people over the last 100 years and it has been part of the expanded program on immunisations since the early-1970s. BCG is effective in preventing disseminated TB disease, including tuberculous meningitis in childhood. However, it does not protect against pulmonary TB in many parts of the world, especially in the tropics where the incidence of TB is at its greatest. Since pulmonary TB is associated with the highest morbidity and mortality, the need to develop an effective vaccine against this disease is paramount, especially in Malawi where BCG protection is known to be minimal.
There are several novel vaccines for TB in clinical development, the most clinically advanced of which is M72/AS01E. The evaluation of candidate TB vaccines is challenging, and progress in the field is hampered by the lack of an immunological correlate of protection. Most routinely administered vaccines generate a quantifiable antibody response that correlates strongly with protection. In contrast, protection against TB is critically dependent on the cellular immune response, in particular CD4+ and also probably CD8+ T cell mediated cellular responses. The mechanisms of these responses are not fully understood .
Currently, to assess vaccine efficacy against TB there is no alternative to large randomized controlled trials. These efficacy trials for novel TB vaccines are difficult, long and very costly. For this reason, there is an urgent need for a valid, reliable, and strong evaluation technique to help distinguish between candidate TB vaccines' likely efficacy at Phase 3. Candidate vaccines which have passed successfully through phase I trials and are in Phase 2b efficacy studies could be included in human challenge protocols which could be designed to either measure prevention of infection (POI) or immunological endpoints. This would allow vaccine discovery to accelerate in a cost-effective manner. Similarly, successful development of new, safe and effective TB therapies face multiple challenges. A responsive controlled human infection model of TB infection could accelerate the development of new drugs and promote refinement of drug combination regimens.
Controlled human infection models (CHIMs) provide insight into disease pathogenesis and correlates of immune protection to support the development of novel vaccines.
The Malawi Liverpool Wellcome Trust has extensive experience of delivering CHIM studies in Malawi with Streptococcus pneumoniae and established technology transfer processes with previous successful transfer of the experimental human pneumococcal carriage model from Liverpool to Blantyre, Malawi. Before the Malawi BCG study, the team will also confirm feasibility of this established BCG model in Liverpool. The Liverpool team will be able to share techniques and expertise and compare data as the Liverpool population will have a different experience of BCG and tuberculosis in the community and are likely to show different results. A TB CHIM established in both the UK and Malawi has the potential to rapidly advance development of vaccines and therapeutics fit for use in populations that need them most.
- Conditions
- Tuberculosis
- Being tested
- BCG
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCGBiological
Also called Bacille Calmette Guerin
Three dose levels of intradermal BCG
| Study group | Role | What they receive |
|---|---|---|
| Low dose of BCG being tested in dose ranging study | Experimental | The lowest dose of BCG (standard Malawi BCG vaccine (BCG Bulgaria 150000-600000 cfu) given as intradermal injection) will be used to determine safety and feasibility. The investigators do not expect to be able to meet study endpoints in this arm which will recruit 10 subjects. Receives: Biological: BCG |
| Mid-range dose BCG being tested in dose ranging study | Experimental | The mid-range dose of BCG (4x standard Malawi dose (BCG Bulgaria 600000-2400000 cfu intradermal) and equal to the model tested in Oxford, UK) will be used to determine safety and feasibility. The investigators hope to to be able to meet study endpoints (measuring microbiological and immunological features of BCG skin lesion) in this arm which will recruit 10 subjects. Receives: Biological: BCG |
| High dose BCG being tested in dose ranging study | Experimental | The highest dose of BCG (10x standard Malawi dose (BCG Bulgaria 2400000-9600000 cfu intradermal) and equal to USA dose used in Seattle) will be used to determine safety and feasibility. The investigators expect to be able to meet study endpoints in this arm which will recruit 10 subjects. In the event that study endpoints are met in the mid-range dose, the investigators will introduce a rifampicin dosing schedule to this arm. Receives: Biological: BCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Culture and PCR ascertainment of BCG load
BCG will be quantified in 4mm skin punch biopsy
Measured: 14 days
Secondary outcomes (1)
Immunological response to BCG
Innate, humoral and cellular immune functions will be quantified in 4mm skin punch biopsy, mucosal and blood samples using ELISA, flow cytometry, 10X single cell and geospatial transcriptomics.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (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.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- A feasibility study of a controlled human infection model (CHIM) with intradermal bacillus Calmette-Guérin (BCG) injection in Malawi
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool School of Tropical Medicine, United Kingdom, Fred Hutchinson Cancer Center, University of Liverpool, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Oxford
- Responsible party
- Sponsor
- Investigators
- Stephen Gordon, MD, Principal investigator, Malawi Liverpool Wellcome Programme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178666
- Sponsor's protocol ID
- 23-Marvels-003
- Other IDs
- 23-083
- Acronym
- MLWBCGCHIM
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymised data will be shared in an online database. IPD would breach data protection guidelines and will not be necessary to interpret the study.
Publications
Lin LL, Prow TW, Raphael AP, Harrold Iii RL, Primiero CA, Ansaldo AB, Soyer HP. Microbiopsy engineered for minimally invasive and suture-free sub-millimetre skin sampling. F1000Res. 2013 May 2;2:120. doi: 10.12688/f1000research.2-120.v2. eCollection 2013.
PubMed 24627782Lei BUW, Yamada M, Hoang VLT, Belt PJ, Moore MH, Lin LL, Flewell-Smith R, Dang N, Tomihara S, Prow TW. Absorbent Microbiopsy Sampling and RNA Extraction for Minimally Invasive, Simultaneous Blood and Skin Analysis. J Vis Exp. 2019 Feb 21;(144). doi: 10.3791/58614.
PubMed 30855573
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Controlled Human Infection Model (CHIM) With Intradermal Bacillus Calmette-Guérin (BCG) Injection in Malawi
- ClinicalTrials.gov ID
- NCT06178666
- Acronym / sponsor ID
- MLWBCGCHIM / 23-Marvels-003
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Liverpool School of Tropical Medicine, United Kingdom, Fred Hutchinson Cancer Center, University of Liverpool, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, University of Oxford
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Dec 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.
Despite tremendous efforts, an effective tuberculosis (TB) vaccine remains elusive. TB continues to infect and kill many. In 2021, TB infected more than 10 million and killed 1.6 million people. To date, the M.bovis bacille Calmette Guerin (BCG) is the only licensed vaccine against tuberculosis (TB). Efforts to come up with new and effective vaccines have not been successful. Partially, the lack of suitable disease models and protection correlates hinders the research of new vaccines. Controlled human infection model studies (CHIM) involve administering disease-causing microbes to healthy individuals, with continued monitoring of disease response. These studies have been used to study malaria, typhoid, pneumococcal pneumonia and the recent SARS-CoV-2 vaccines. The BCG-Controlled Human Infection Model (BCG-CHIM) will allow accurate dosing with safe mycobacteria as well as minimal tissue sampling to understand immunity to mycobacteria. Considering that the M. bovis BCG is a safe living Mycobacteria, it can be used as a CHIM against which to test new vaccines.
Detailed description
Tuberculosis (TB) is a leading cause of death from a single infectious agent worldwide and is an acknowledged major challenge in Malawi. Globally in 2021, there were an estimated 10.6 million people unwell with TB and an estimated 1.6 million deaths caused by TB. Furthermore, the global TB incidence could be accelerated to an average of 17% per year between 2025 and 2035 owing to the disruption to TB services caused by the COVID pandemic. TB diagnosis is challenging, and drug treatment can be prolonged, harmful, costly, and complex, especially in the increasingly common context of drug resistant M. tuberculosis. For these reasons an effective vaccine to prevent disease is a global public health priority, and drugs to allow shorter courses of effective therapy are urgently needed.
At present, the only licensed vaccine is the bacille Calmette-Guérin (BCG) vaccine (BCG Bulgaria is the Malawi licensed strain). BCG has been administered globally to several billion people over the last 100 years and it has been part of the expanded program on immunisations since the early-1970s. BCG is effective in preventing disseminated TB disease, including tuberculous meningitis in childhood. However, it does not protect against pulmonary TB in many parts of the world, especially in the tropics where the incidence of TB is at its greatest. Since pulmonary TB is associated with the highest morbidity and mortality, the need to develop an effective vaccine against this disease is paramount, especially in Malawi where BCG protection is known to be minimal.
There are several novel vaccines for TB in clinical development, the most clinically advanced of which is M72/AS01E. The evaluation of candidate TB vaccines is challenging, and progress in the field is hampered by the lack of an immunological correlate of protection. Most routinely administered vaccines generate a quantifiable antibody response that correlates strongly with protection. In contrast, protection against TB is critically dependent on the cellular immune response, in particular CD4+ and also probably CD8+ T cell mediated cellular responses. The mechanisms of these responses are not fully understood .
Currently, to assess vaccine efficacy against TB there is no alternative to large randomized controlled trials. These efficacy trials for novel TB vaccines are difficult, long and very costly. For this reason, there is an urgent need for a valid, reliable, and strong evaluation technique to help distinguish between candidate TB vaccines' likely efficacy at Phase 3. Candidate vaccines which have passed successfully through phase I trials and are in Phase 2b efficacy studies could be included in human challenge protocols which could be designed to either measure prevention of infection (POI) or immunological endpoints. This would allow vaccine discovery to accelerate in a cost-effective manner. Similarly, successful development of new, safe and effective TB therapies face multiple challenges. A responsive controlled human infection model of TB infection could accelerate the development of new drugs and promote refinement of drug combination regimens.
Controlled human infection models (CHIMs) provide insight into disease pathogenesis and correlates of immune protection to support the development of novel vaccines.
The Malawi Liverpool Wellcome Trust has extensive experience of delivering CHIM studies in Malawi with Streptococcus pneumoniae and established technology transfer processes with previous successful transfer of the experimental human pneumococcal carriage model from Liverpool to Blantyre, Malawi. Before the Malawi BCG study, the team will also confirm feasibility of this established BCG model in Liverpool. The Liverpool team will be able to share techniques and expertise and compare data as the Liverpool population will have a different experience of BCG and tuberculosis in the community and are likely to show different results. A TB CHIM established in both the UK and Malawi has the potential to rapidly advance development of vaccines and therapeutics fit for use in populations that need them most.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- A feasibility study of a controlled human infection model (CHIM) with intradermal bacillus Calmette-Guérin (BCG) injection in Malawi
| Arm | Type | Receives |
|---|---|---|
| Low dose of BCG being tested in dose ranging study | Experimental | Biological: BCGThe lowest dose of BCG (standard Malawi BCG vaccine (BCG Bulgaria 150000-600000 cfu) given as intradermal injection) will be used to determine safety and feasibility. The investigators do not expect to be able to meet study endpoints in this arm which will recruit 10 subjects. |
| Mid-range dose BCG being tested in dose ranging study | Experimental | Biological: BCGThe mid-range dose of BCG (4x standard Malawi dose (BCG Bulgaria 600000-2400000 cfu intradermal) and equal to the model tested in Oxford, UK) will be used to determine safety and feasibility. The investigators hope to to be able to meet study endpoints (measuring microbiological and immunological features of BCG skin lesion) in this arm which will recruit 10 subjects. |
| High dose BCG being tested in dose ranging study | Experimental | Biological: BCGThe highest dose of BCG (10x standard Malawi dose (BCG Bulgaria 2400000-9600000 cfu intradermal) and equal to USA dose used in Seattle) will be used to determine safety and feasibility. The investigators expect to be able to meet study endpoints in this arm which will recruit 10 subjects. In the event that study endpoints are met in the mid-range dose, the investigators will introduce a rifampicin dosing schedule to this arm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy adults aged 18-50 (inclusive)
- Resident near QECH, Blantyre (\<1 hour drive) for the duration of the study period
- Allows the investigators to review the volunteer's medical history in the health passport book.
- Females of childbearing potential with a negative urine pregnancy test at screening and willing to practice adequate birth control measures during the study.
- Fluent spoken English or Chichewa - to ensure a comprehensive understanding of the research project and their proposed involvement.
Key exclusion criteria (22 listed)
- Laboratory evidence at screening of subclinical M. tb infection as indicated by a positive ELISPOT response to ESAT-6 or CFP-10 antigens. Volunteers discovered to have evidence of latent M. tb infection as defined by a positive ELISPOT test will be referred to the chest clinic for investigation for tuberculosis according to Malawi standard protocols.
- Clinical, radiological, or laboratory evidence of current active TB disease
- Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, or psychiatric disorder.
- Current medical issues. Volunteers who are excluded from the study because they have been discovered to have a previously undiagnosed condition thought to require further medical attention will be referred appropriately to QECH specialist services for further investigation and treatment.
- Acute respiratory tract infection in the four weeks preceding recruitment
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 |
|---|---|---|
| BCGAlso: Bacille Calmette GuerinThree dose levels of intradermal BCG | Biological | High dose BCG being tested in dose ranging study, Low dose of BCG being tested in dose ranging study, Mid-range dose BCG being tested in dose ranging study |
Primary outcome
Culture and PCR ascertainment of BCG load
Time frame: 14 days
BCG will be quantified in 4mm skin punch biopsy
1 secondary outcome
Immunological response to BCG
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Background: PubMed 24627782Lin LL, Prow TW, Raphael AP, Harrold Iii RL, Primiero CA, Ansaldo AB, Soyer HP. Microbiopsy engineered for minimally invasive and suture-free sub-millimetre skin sampling. F1000Res. 2013 May 2;2:120. doi: 10.12688/f1000research.2-120.v2. eCollection 2013.
- Background: PubMed 30855573Lei BUW, Yamada M, Hoang VLT, Belt PJ, Moore MH, Lin LL, Flewell-Smith R, Dang N, Tomihara S, Prow TW. Absorbent Microbiopsy Sampling and RNA Extraction for Minimally Invasive, Simultaneous Blood and Skin Analysis. J Vis Exp. 2019 Feb 21;(144). doi: 10.3791/58614.
- Individual participant dataSharing planned: No. Anonymised data will be shared in an online database. IPD would breach data protection guidelines and will not be necessary to interpret the study.
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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.
Stephen Gordon, MD principal investigator
Malawi Liverpool Wellcome Programme
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BCG in people with Tuberculosis, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
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 7 inclusion and 22 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 21 Dec 2023. 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 Malawi. 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?
Contact Stephen B Gordon, MD (265992552382, sgordon@mlw.mw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Culture and PCR ascertainment of BCG load (time frame: 14 days). 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 NCT06178666, 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 21 Dec 2023.