Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT07157904
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of PATHFAST-LAM as a Tuberculosis Treatment Monitoring Tool in Kenya
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}], 'ancestors': [{'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-05', 'studyFirstSubmitDate': '2025-08-28', 'studyFirstSubmitQcDate': '2025-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite Poor Outcome', 'timeFrame': 'From enrollment to 3 months after treatment completion', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tuberculosis', 'Treatment Monitoring Tool', 'Lipoarabinomannan'], 'conditions': ['Tuberculosis', 'Pulmonary Tuberculoses', 'Mycobacterium Tuberculosis']}, 'descriptionModule': {'briefSummary': "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.\n\nThe primary objective of this study is to assess whether changes in sputum LAM levels can help predict unfavorable results.\n\nIn 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.\n\nIt 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Patients with a recent diagnosis of bacteriologically confirmed PTB who have not yet initiated TB treatment.\n* Patients who are willing and able to visit to the facility for follow-up sample collection and interviews.\n* Patients who are willing and able to provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n\\- Patients with a history of TB treatment within the past 6 months, including retreatment.'}, 'identificationModule': {'nctId': 'NCT07157904', 'briefTitle': 'Evaluation of PATHFAST-LAM as a Tuberculosis Treatment Monitoring Tool in Kenya', 'organization': {'class': 'OTHER', 'fullName': 'Nagasaki University'}, 'officialTitle': 'Evaluating the PATHFAST TB LAM Ag Assay as a Treatment Monitoring Tool for Pulmonary Tuberculosis: A Prospective Longitudinal Study in Nairobi, Kenya', 'orgStudyIdInfo': {'id': 'KEMRI/SERU/CRDR/124/5241'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Tuberculosis Patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nairobi', 'country': 'Kenya', 'contacts': [{'name': 'Nobuo Saito, MD, PhD', 'role': 'CONTACT', 'email': 'nsaito@nagasaki-u.ac.jp', 'phone': '+254773406090'}], 'facility': 'Mbagathi County Referral Hospital', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}, {'city': 'Nairobi', 'country': 'Kenya', 'contacts': [{'name': 'Nobuo Saito, MD, PhD', 'role': 'CONTACT', 'email': 'nsaito@nagasaki-u.ac.jp', 'phone': '+254773406090'}], 'facility': 'Rhodes Chest Clinic', 'geoPoint': {'lat': -1.28333, 'lon': 36.81667}}], 'centralContacts': [{'name': 'Nobuo Saito, MD, PhD', 'role': 'CONTACT', 'email': 'nsaito@nagasaki-u.ac.jp', 'phone': '+2540773406090'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nagasaki University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nobuo Saito', 'investigatorAffiliation': 'Nagasaki University'}}}}