To compare two treatments for pulmonary tuberculosis
Conditions
Interventions
Trade Name: Isoniazid
Product Name: Isoniazid
Pharmaceutical Form: Tablet
INN or Proposed INN: Isoniazid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-
Pharma
Sponsors
TB Investigation Unit of Barcelona
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Suspected pulmonary tuberculosis with acid-fast bacilli in a stained sputum smear. Patients whose sputum cultures do not grow M. tuberculosis, and those having an M. tuberculosis isolate resistant to isoniazid, rifampin, fluoroquinolones, or any 2 study drugs will be discontinued from the study, but followed for 14 days to detect late toxicities from study therapy. Patients having extra-pulmonary manifestations of tuberculosis, in addition to smear-positive pulmonary disease, are eligible for enrollment. 2. Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 6 months prior to enrollment 3. 14 or fewer days of multidrug therapy for tuberculosis disease in the 6 months preceding enrollment 4. 10 or fewer days of treatment with a fluoroquinolone during the 3 months preceding enrollment 5. Age > 18 years 6. Karnofsky score of at least 60 (requires occasional assistance but is able to care for most of his/her needs) 7. Signed informed consent 8. Women with child bearing potential must agree to practice an adequate (barrier) method of birth control or to abstain from heterosexual intercourse during study therapy. 9. Laboratory parameters done at, or 3.0 meq/L ? Negative pregnancy test (for women of childbearing potential) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Breast-feeding 2. Known intolerance to any of the study drugs 3. Known allergy to any fluoroquinolone antibiotic 4. Concomitant disorders or conditions for which moxifloxacin, isoniazid, rifampin, pyrazinamide, or ethambutol are contraindicated. These include severe hepatic damage, acute liver disease of any cause, and acute uncontrolled gout. 5. Current or planned therapy during the intensive phase of tuberculosis treatment using drugs having unacceptable interactions with rifampin (rifabutin can be substituted for rifampin during the continuation phase of therapy) 6. Current or planned antiretroviral therapy during the intensive phase of tuberculosis treatment 7. History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during the intensive phase of tuberculosis treatment. 8. Pulmonary silicosis 9. Central nervous system TB
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the culture-conversion rates at the end of the intensive phase of therapy of the moxifloxacin regimen vs. that of the isoniazid regimen;Primary end point(s): 1. The proportion of patients having a negative sputum culture at 2 months of therapy 2. The proportion of patients who discontinue assigned study therapy for any reason during the first 2 months ;Secondary Objective: To compare the safety and tolerability of the moxifloxacin regimen to that of the isoniazid regimen To determine the time to culture-conversion of the moxifloxacin regimen and the isoniazid regimen, using data from 2-, 4-, 6-, and 8-week cultures. To compare the proportion of patients with any Grade 3 or 4 adverse reactions To compare adverse events and 2-month culture conversion rate among HIV-infected patients vs. HIV-uninfected patients To compare the rates of treatment failure of the moxifloxacin regimen to the isoniazid regimen To determine whether there is delayed toxicity attributable to moxifloxacin (toxicity that becomes evident after the 2 months of moxifloxacin therapy) | — |
Countries
Spain
Outcome results
None listed