Efficacy of N-acetylcysteine for sputum smear conversion in pulmonary tuberculosis; multicenter open- label pragmatic randomized controlled trial
Phase 3
- Conditions
- Pulmonary tuberculosis was defined by exhibited chronic cough more than 2weeks with or without hemoptysis,chest pain,tachypnea,constitutionalsymptoms and sputum smear positive of acid fast baciPulmonary tuberculosis,sputum smear conversion
- Registration Number
- TCTR20190128002
- Lead Sponsor
- Khon Kaen Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 220
Inclusion Criteria
The patients 18 years of age or older who newly diagnosed
PTB and agreement to participate in the study will eligible
for enrollment.
Exclusion Criteria
We will exclude the patients who are pregnant or breastfeeding, known hypersensitivity to NAC, HIV positive, history of massive hemoptysis (NAC may exacerbate severity of hemoptysis), estimating glomerular filtration rate less than 30 mL/min/1.73 m 2 , moribund state, history of porphyria, pre-existing liver disease, known rifampicin and/or multidrug resistance tuberculosis and earlier anti-tuberculosis treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy of NAC for sputum smear conversion in pulmonary tuberculosis end of 2 weeks, 4 weeks and 8 weeks after treatment event rate,adverse events along period of study event rate ,hospital admission, along period of study event rate ,needed mechanical ventilator, along period of study event rate ,acquired drug resistant regimen, along period of study event rate
- Secondary Outcome Measures
Name Time Method adverse events along period of study event rate ,hospital admission along period of study event rate ,needed mechanical ventilator along period of study event rate ,acquired drug resistant regimen along period of study event rate