patient with pulmonary tuberculosis pulmonary tuberculosis treatment,
Conditions
Interventions
volunteers recieve oral standard medicine and study drug
dry powder inhaler nanoparticle dosage form composes of isoniazid rifampicin pyrazinamide levofloxacin filling together in one capsule.,volunteers recieve oral standard medicine and placebo of dry pow
Experimental Drug,Placebo Comparator Drug
dry powder inhaler of 4 kinds of medicine
Isoniazid levofloxacin pyyrazinamide rifampicin,placebo
Sponsors
Government Pharmaceutical Organization (GPO)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: new case and retreatment pulmonary tuberculosis, sputum AFB positive, have clinical symptoms of TB (cough > 3 week, lose weight, night sweat, abnormal film CXR), comply to clinical trial, mono resistant pulmonary TB
Exclusion criteria
Exclusion criteria: pregnancy and breast feeding, MDR TB, estimate peak expiratory flow rate > 60 L/min, ALT>125 U/L, HIV sero positive, allergy to research drugs, uncontrol asthma, copd, drug addict, use fluoroquinolone with in 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy, sputum culture conversion 8 weeks positive or negative,sputum culture conversion 8 weeks positive or negative | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Liverfunction test, serum uric acid , clinical of adverse reaction of oral treat and DPI 2 month 6 month level of AST, ALT, tB, dB, ALK , interview | — |
Countries
Thailand
Contacts
Public Contactnisa laohapojanart
Faculty of Pharmacy, Prince of Songkla university
Outcome results
None listed