Skip to content

Efficacy of N-acetylcysteine for sputum smear conversion in pulmonary tuberculosis; multicenter open- label pragmatic randomized controlled trial

Efficacy of N-acetylcysteine for sputum smear conversion in pulmonary tuberculosis; multicenter open- label pragmatic randomized controlled trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20190128002
Enrollment
220
Registered
2019-01-28
Start date
2019-03-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary tuberculosis was defined by exhibited chronic cough more than 2 weeks with or without hemoptysis&#44

Interventions

treated with once daily standard drug regimen in intensive phase of tuberculosis treatment including isoniazid (INH) 5 mg/kg&#44
rifampicin (RIF) 10 mg/kg&#44
pyrazinamide (PZA) 25 mg/kg and ethambutol (ETB) 15 mg/kg.,same standard drug regimen and NAC (600 mg&#44
orally&#44
twice daily&#44
14 days along with the start of PTB treatment.
Active Comparator Drug,Experimental Drug
standard drug regimen,NAC plus standard drug regimen

Sponsors

Khon Kaen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 0 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactPantipa Meethonglang

Khon Kaen Hospital

pantipameethonglang@gmail.com+6683381599

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026