Tuberculosis
Conditions
Interventions
DiagNoze TB Screening Device
DiagNoze TB Screening
Sponsors
Stratuscent Inc operating as NOZE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Between the ages of =18-80 years, of any gender ? Able to provide informed consent in either English or Kiswahili. The participants must be proficient in either English or Kiswahili. Kericho is a Cosmopolitan area, with Kalenjin, Luo, Luhya, Kisii and several other ethnic groups present in substantial numbers. Our previous studies have shown that Swahili and English are widely spoken by all population demographics. ? Participants with Pulmonary TB, bacteriologically confirmed by GeneXpert MTB/RIF Ultra on at least one sputum sample, or urine TB Lippoarabinomannan (TB LAM for participant who cannot produce sputum like HIV patients, collected within 7 days preceding the screening visit. ? Participants have not consumed alcohol, tobacco (in a consumable format), vape, marijuana or drugs, eight (8) hours prior to the breath test. ? Participants must consume only water 1 hour prior to testing. ? Participants must not have brushed their teeth within 2 hours prior to the breath test. ? Participants must not have provided a test sample (blood, sputum or urine) within 8 hours prior to providing a breath sample. ? Participants should have fasted 8 hours prior to providing a breath sample, where this can be accommodated. ? For control Participants, demographic and lifestyle matched to cases, as close to possible within reason but not infected with TB. Specifically, the participants for the control cohort will be matched for age, sex, smoking history (smoker vs nonsmoker) and alcohol consumption (alcoholic vs non-alcoholic). The cases should be confirmed by GeneXpert MTB/RIF negative.
Exclusion criteria
Exclusion criteria: ? History of severe asthma, diabetes, and medications that may affect metabolism and influence breath odor or VOC profiles. Some of the medications that may affect the breath VOC profile are Propofol, Eucalyptol, Laxatives, Corticosteroids, Anti-inflammatory, Anti-diabetic, Statins, Anti-migraine, Anxiolytics, (Non) ß2 adrenergic receptor agonist (42, 43, 44, 45). Known concurrent respiratory disease which may act as a confounder for tuberculosis (e.g. COVID-19). ? Those with acute respiratory or other infection within the preceding month ? Infection with extrapulmonary TB ? Pregnant women (the composition of breath volatile organic compounds is altered during pregnancy and this can impact the study results. ? Systemic Lupus Erythematosus (SLE) ? Sjogren’s Syndrome or other similar disorders ? Participants must not be currently undergoing treatment for malignancy. ? Participants with unstable medical conditions that may interfere with the study objectives or pose a risk to the participant's safety, such as severe ? Chronic Obstructive Pulmonary Disease (COPD). ? For TB participants, bacteriologically confirmed with trace positive result only on sputum collected within 7 days preceding the screening visit or have received curative TB treatment for the current TB episode
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of different data clustering methods in terms of ability to cluster the digitized breath datasets produced by the DiagNoze® breathalyzer and as either TB positive or TB negative. | — |
Secondary
| Measure | Time frame |
|---|---|
| Data features pertaining to Volatile Organic Compounds mixtures that are common across active TB, latent TB and TB with HIV patients. | — |
Countries
Kenya
Contacts
Public ContactMichael Obonyo
Regulatory Officer
Outcome results
None listed