An observational study in Tuberculosis, Pulmonary Tuberculoses and Mycobacterium Tuberculosis, sponsored by Nagasaki University. Not yet recruiting at 2 sites in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Nagasaki University · Observational
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.
319 studies on the registry are indexed under Tuberculosis, Pulmonary; 71 are open to participants now.
This study's planned enrollment of 300 is close to the median of 300 across 83 observational studies indexed under Tuberculosis, Pulmonary.
Browse Tuberculosis, Pulmonary studies →Nagasaki University is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Compared within Tuberculosis, Pulmonary, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Tuberculosis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
- Patients with a history of TB treatment within the past 6 months, including retreatment.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: From enrollment to 3 months after treatment completion
This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Nagasaki University