Thai Patients with Clinically Suspected Smear-Negative Pulmonary Tuberculosis sputum induction induced sputum bronchodilator-enhanced sputum induction pulmonary tuberculosis Thailand
Conditions
Interventions
Ipratropium bromide fenoterol hydrobromide forte (Inhalex forte) 2 milliliters will be mixed with 3 percent hypertonic saline solution, 3 milliliters (totaling 5 milliliters). the solution will be neb
Experimental Drug,Active Comparator Drug
Bronchodilator Enhanced Sputum Induction,Conventional Sputum Induction (standard of care)
Sponsors
Faculty of Medicine, Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Thai patients aged 18 years or older. 2. Exhibiting clinical symptoms or radiological findings consistent with pulmonary tuberculosis, and suspected by the attending physician to have pulmonary tuberculosis or pulmonary tuberculosis in conjunction with extrapulmonary tuberculosis. 3. Initial sputum examination (spot sputum) shows no evidence of tuberculosis through acid-fast bacilli staining and Xpert MTB/RIF Ultra testing, or patients unable to produce effective sputum samples due to insufficient cough strength. 4. Not currently undergoing treatment for tuberculosis or latent tuberculosis. 5. Voluntarily consent to participate in the research and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnant women. 2. Patients with bronchospasm or a history of severe bronchospasm induced by sputum induction, or a history of pulmonary function tests showing a decrease in FEV1 by more than 20% post-sputum induction. 3. Patients with severe respiratory issues, including: 3.1. Severe or uncontrolled asthma, meeting at least one of the following criteria: 3.1.1. Exhibiting more than three of the following symptoms: (a) Daytime breathlessness more than twice a week. (b) Nighttime breathlessness more than once a week. (c) Use of emergency inhalation medication more than twice a week. (d) Asthma symptoms affecting daily activities at least once a week (Activity limitation). 3.1.2. History of pulmonary function tests with FEV1 less than 60% of the predicted value by age, or less than 1 liter, or peak expiratory flow rate variability greater than 30%. 3.1.3. Asthma exacerbation within 4 weeks prior to study participation. 3.2. Severe emphysema, meeting at least one of the following criteria: 3.2.1. Classified as GOLD classification 3 or higher. 3.2.2. History of pulmonary function tests with FEV1 less than 50% of the predicted value by age. 3.2.3. Emphysema exacerbation within 4 weeks prior to study participation. 4. Patients with severe or uncontrolled comorbidities that the physician deems could pose a risk during sputum induction, whether by standard methods or using bronchodilator-assisted induction. These conditions include severe arrhythmias, heart failure or acute myocardial ischemia, severe hypoxemia, high levels of hepatic or renal insufficiency, unconsciousness or unresponsiveness, or uncontrolled epilepsy. 5. Patients currently using bronchodilator inhalers who cannot discontinue their use for at least 6-12 hours. 6. Patients with an allergy to the bronchodilators Ipratropium bromide or Fenoterol hydrobromide. 7. Patients or their relatives who do not consent to participation in the study. 8. Patients who do not cooperate or are unable to follow instructions for sputum induction (excluding patients with disabilities, such as limb impairment or blindness, who can still cooperate and follow instructions). 9. Patients requiring or unable to discontinue the following medications: aclidinium, beta-2 agonists (e.g., terbutaline, dopamine, dobutamine, norepinephrine), cimetropium, eluxadoline, glycopyrrolate, kratom, levosulpiride, loxapine, oxatomide, pramlintide, revefenacin, umeclidinium. 10. Patients receiving medications that are components of tuberculosis treatment regimens and have direct activity against Mycobacterium tuberculosis for other therapeutic indications for more than 2 weeks, such as Rifampicin for endocarditis or Levofloxacin for bacterial infections.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tuberculosis detection after intevention X-pert MTB/RIF ultra | — |
Secondary
| Measure | Time frame |
|---|---|
| Tuberculosis detection after intevention conventional culture method,Tuberculosis detection after intevention Acid fast bacilli staining,safety outcome, adverse drug reaction after intevention observe and report | — |
Countries
Thailand
Contacts
Public ContactPichanon Mingchay
Chulalongkorn University
Outcome results
None listed