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ClinicalTrials.gov ID

NCT07157904

Lead Sponsor

Nagasaki UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

300Estimated

Last Update Posted

Sep 12, 2025Actual

Start Date

Jan 2026Estimated

Primary Completion Date

Jul 2027Estimated

Completion Date

Jul 2027Estimated

Official Title

Evaluating the PATHFAST TB LAM Ag Assay as a Treatment Monitoring Tool for Pulmonary Tuberculosis: A Prospective Longitudinal Study in Nairobi, Kenya

Brief 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 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.

• Tuberculosis
• Pulmonary Tuberculoses
• Mycobacterium Tuberculosis

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No data available

Eligibility Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

- Patients with a history of TB treatment within the past 6 months, including retreatment.

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Nagasaki UniversityOTHER

nsaito@nagasaki-u.ac.jp+254773406090