TuberculosisNCT07157904
Evaluation of PATHFAST-LAM as a Tuberculosis Treatment Monitoring Tool in Kenya
An observational study of Tuberculosis and Pulmonary Tuberculoses, run by Nagasaki University at 2 sites in Kenya.
Trial summary
Tuberculosis (TB) can be treated; however, the standard 6-month treatment is long and challenging for many patients, and 10-20% still don't recover well by the end of treatment. Thus, it's important to regularly check if the treatment is working to help patients get better and prevent drug-resistant TB from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tuberculosis, Pulmonary Tuberculoses, Mycobacterium Tuberculosis
- How many people
- 300 participants
- Where
- 2 sitesKenya
- Study dates
- Jan 2026to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: To ensure a representative sample reflecting a broad spectrum of TB disease severity and healthcare access, investigators will recruit participants from multiple healthcare facilities at different levels of the Kenyan health system. The primary study sites include Rhodes Chest Clinic (RCC) and Mbagathi County Referral Hospital (MCH). RCC is a Level 2 healthcare facility which serves as a specialized primary care center for TB patients, recording approximately 700-800 new PTB cases every year. MCH is a Level 5 referral hospital offering both outpatient and inpatient care with a bed capacity of around 150. MCH manages 1,000 new TB cases annually.
Who may be able to join
- Adults aged 18 years or older
- Patients with a recent diagnosis of bacteriologically confirmed PTB who have not yet initiated TB treatment.
- Patients who are willing and able to visit to the facility for follow-up sample collection and interviews.
- Patients who are willing and able to provide written informed consent to participate in the study.
Who cannot join
- Patients with a history of TB treatment within the past 6 months, including retreatment.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kenya2 sites
Mbagathi County Referral Hospital
Nairobi
Nobuo Saito, MD, PhD, +254773406090, nsaito@nagasaki-u.ac.jp
Rhodes Chest Clinic
Nairobi
Nobuo Saito, MD, PhD, +254773406090, nsaito@nagasaki-u.ac.jp
About this study
Official title: Evaluating the PATHFAST TB LAM Ag Assay as a Treatment Monitoring Tool for Pulmonary Tuberculosis: A Prospective Longitudinal Study in Nairobi, Kenya
Tuberculosis (TB) can be treated; however, the standard 6-month treatment is long and challenging for many patients, and 10-20% still don't recover well by the end of treatment. Thus, it's important to regularly check if the treatment is working to help patients get better and prevent drug-resistant TB from developing. It can, however, be especially hard to check if TB treatment is working in places with limited resources. Traditional methods, such as testing sputum samples for microscopy and culture, have limitations. Lipoarabinomannan (LAM) is a substance that is found in the cell wall of the bacteria that cause TB, which can be used as an indicator for TB diagnosis and treatment monitoring. The PATHFAST TB LAM Ag test is a fully automatic machine that checks for LAM in sputum. It could offer a faster and more accurate way to see if TB treatment is working. This study aims to find out how helpful the PATHFAST-LAM test is in monitoring TB treatment progress among Kenyan TB patients.
The primary objective of this study is to assess whether changes in sputum LAM levels can help predict unfavorable results.
Read more
In this study, investigators will recruit adult patients diagnosed with pulmonary TB from multiple healthcare facilities in Nairobi, Kenya. Investigators will follow them during their TB treatment and collect sputum and urine samples at the beginning of treatment, then, every week for the first month, every two weeks for the next two months, and monthly for months 3-6. Investigators will use the PATHFAST-LAM test to measure LAM levels in sputum and urine. Since there are no previous studies that have evaluated the relationship between sputum LAM and treatment outcome, investigators will do an initial analysis with 30 participants, and based on that, investigators will determine the final number of participants needed for our study.
It is expected that sputum LAM decreases when the treatment is successful and remains positive (does not decrease) when treatment is unsuccessful, with patients experiencing unfavorable results. How LAM decreases during the earlier course of TB treatment may be useful in predicting patients' outcomes. The results of this study could provide a faster and effective way for monitoring TB treatment. This could contribute to improved patient outcomes and help reduce the global burden of TB.
- Keywords
- Tuberculosis, Treatment Monitoring Tool, Lipoarabinomannan
- Medical subject headings
- Tuberculosis, Tuberculosis, Pulmonary
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 |
|---|---|---|
| Pulmonary Tuberculosis Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Poor Outcome
Patients who meet any of the following criteria: (1) Death due to any cause, (2) Discontinuation of TB treatment for more than 2 months consecutively, (3) Early relapse (within 3 months after completing TB treatment), (4) Change in TB treatment regimen for any reason, or (5) No culture conversion at the end of TB treatment.
Measured: From enrollment to 3 months after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study startJan 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagasaki University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nobuo Saito, Nagasaki University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07157904
- Sponsor's protocol ID
- KEMRI/SERU/CRDR/124/5241
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Takaizumi Y, Kinoti J, Hikone M, Orina F, Meme H, Ong'ang'o JR, Muriithi B, Mueni E, Kaneko S, MacLean EL, Sato S, Saito N. Evaluating the PATHFAST TB LAM Ag assay as a treatment monitoring tool for pulmonary tuberculosis: protocol for a prospective longitudinal study in Nairobi, Kenya. BMJ Open. 2026 Jan 13;16(1):e113578. doi: 10.1136/bmjopen-2025-113578.
PubMed 41529882
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the PATHFAST TB LAM Ag Assay as a Treatment Monitoring Tool for Pulmonary Tuberculosis: A Prospective Longitudinal Study in Nairobi, Kenya
- ClinicalTrials.gov ID
- NCT07157904
- Acronym / sponsor ID
- KEMRI/SERU/CRDR/124/5241
- Keywords
- Tuberculosis, Treatment Monitoring Tool, Lipoarabinomannan
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Nagasaki UniversityUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 5 Sep 2025 (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) can be treated; however, the standard 6-month treatment is long and challenging for many patients, and 10-20% still don't recover well by the end of treatment. Thus, it's important to regularly check if the treatment is working to help patients get better and prevent drug-resistant TB from developing. It can, however, be especially hard to check if TB treatment is working in places with limited resources. Traditional methods, such as testing sputum samples for microscopy and culture, have limitations. Lipoarabinomannan (LAM) is a substance that is found in the cell wall of the bacteria that cause TB, which can be used as an indicator for TB diagnosis and treatment monitoring. The PATHFAST TB LAM Ag test is a fully automatic machine that checks for LAM in sputum. It could offer a faster and more accurate way to see if TB treatment is working. This study aims to find out how helpful the PATHFAST-LAM test is in monitoring TB treatment progress among Kenyan TB patients.
The primary objective of this study is to assess whether changes in sputum LAM levels can help predict unfavorable results.
In this study, investigators will recruit adult patients diagnosed with pulmonary TB from multiple healthcare facilities in Nairobi, Kenya. Investigators will follow them during their TB treatment and collect sputum and urine samples at the beginning of treatment, then, every week for the first month, every two weeks for the next two months, and monthly for months 3-6. Investigators will use the PATHFAST-LAM test to measure LAM levels in sputum and urine. Since there are no previous studies that have evaluated the relationship between sputum LAM and treatment outcome, investigators will do an initial analysis with 30 participants, and based on that, investigators will determine the final number of participants needed for our study.
It is expected that sputum LAM decreases when the treatment is successful and remains positive (does not decrease) when treatment is unsuccessful, with patients experiencing unfavorable results. How LAM decreases during the earlier course of TB treatment may be useful in predicting patients' outcomes. The results of this study could provide a faster and effective way for monitoring TB treatment. This could contribute to improved patient outcomes and help reduce the global burden of TB.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Tuberculosis Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- To ensure a representative sample reflecting a broad spectrum of TB disease severity and healthcare access, investigators will recruit participants from multiple healthcare facilities at different levels of the Kenyan health system. The primary study sites include Rhodes Chest Clinic (RCC) and Mbagathi County Referral Hospital (MCH). RCC is a Level 2 healthcare facility which serves as a specialized primary care center for TB patients, recording approximately 700-800 new PTB cases every year. MCH is a Level 5 referral hospital offering both outpatient and inpatient care with a bed capacity of around 150. MCH manages 1,000 new TB cases annually.
Key inclusion criteria (4 listed)
- Adults aged 18 years or older
- Patients with a recent diagnosis of bacteriologically confirmed PTB who have not yet initiated TB treatment.
- Patients who are willing and able to visit to the facility for follow-up sample collection and interviews.
- Patients who are willing and able to provide written informed consent to participate in the study.
Key exclusion criteria (1 listed)
- Patients with a history of TB treatment within the past 6 months, including retreatment.
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
Composite Poor Outcome
Time frame: From enrollment to 3 months after treatment completion
Patients who meet any of the following criteria: (1) Death due to any cause, (2) Discontinuation of TB treatment for more than 2 months consecutively, (3) Early relapse (within 3 months after completing TB treatment), (4) Change in TB treatment regimen for any reason, or (5) No culture conversion at the end of TB treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Derived from this study: PubMed 41529882Takaizumi Y, Kinoti J, Hikone M, Orina F, Meme H, Ong'ang'o JR, Muriithi B, Mueni E, Kaneko S, MacLean EL, Sato S, Saito N. Evaluating the PATHFAST TB LAM Ag assay as a treatment monitoring tool for pulmonary tuberculosis: protocol for a prospective longitudinal study in Nairobi, Kenya. BMJ Open. 2026 Jan 13;16(1):e113578. doi: 10.1136/bmjopen-2025-113578.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis and Pulmonary Tuberculoses, run by Nagasaki University at 2 sites in Kenya.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kenya. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nobuo Saito, MD, PhD (+2540773406090, nsaito@nagasaki-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Poor Outcome (time frame: From enrollment to 3 months after treatment completion). 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 NCT07157904, which also lists 1 linked publication.
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 12 Sep 2025.