Inclusion criteria | Patients eligible for inclusion in the trial must fulfil all of the following criteria: |
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Aged 18 to 65 years (both inclusive) and weighing between 38 and 80 kg | |
Recently diagnosed, microscopically proven, pulmonary tuberculosis, defined as 2 consecutively positive sputum smears, of which one must be equal or exceed grade 1 | |
Findings in medical history and physical examination not exceeding grade 2 according to the Division of Microbiology and Infectious Disease grading system tables (DMID) | |
Voluntarily signed informed consent to participate in the trial | |
Females of childbearing potential must have a confirmed negative pregnancy test at the screening visit and must employ an effective and acceptable method of birth control during the treatment | |
Laboratory values that do not exceed grade 2 using the Division of Microbiology and Infectious Disease grading system (DMID) other than for glycaemia, haemoglobin, and potassium levels | |
Exclusion criteria | Patients who meet any of the following criteria are not eligible for the trial: |
Patients with a history of TB treatment within the last 3 years | |
Concomitant infection requiring additional anti-infective treatment (especially antiretroviral medication) | |
HIV infected patients with WHO stage 3 infection (except those presenting with only the ‘loss of weight >10% body weight’ criterion) and all patients at WHO stage 4 | |
A history of diabetes mellitus (DM) or non-insulin-dependent diabetes mellitus (NIDDM) requiring treatment or diet. Additionally patients who have a fasting glucose level less than 70 mg/dl (3.9 mmol/L) or above 115 mg/dl (6.4 mmol/L) at screening will be excluded | |
Recreational drug abuse and alcohol abuse that, in the opinion of the investigator, could prejudice the conduct of the trial in that patient | |
History of drug hypersensitivity or/and active allergic disease | |
Impaired renal, hepatic, or gastric function that may, in the opinion of the investigator, interfere with drug absorption, distribution, metabolism, or elimination | |
Any other findings in medical history and physical examination exceeding grade 2 in the DMID grading system tables | |
Patient using the following therapies: | |
Other antibiotics with known anti-TB activity (that is ofloxacin, moxifloxacin, kanamycin, and so on) | |
Drugs known to prolong the QT interval (that is antiarrythmics, psychotropics (phenothiazines, tricyclics, tetracyclics), erythromycin, pentamidine, and halofantrine) | |
Drugs known to give photosensitivity reactions | |
Receiving oral corticosteroids for more than 2 weeks immediately prior to inclusion | |
Use of antacids containing aluminium or magnesium salts or sucralfate | |
Digoxin | |
Drugs that are eliminated via tubular secretion (for example, probenecid, cimetidine, ranitidine) | |
Pregnant or lactating women | |
Patients with congenital QT interval prolongation defined as > 480 ms | |
Patients with clinically significant bradycardia defined as <40 bpm | |
Baseline laboratory values exceeding grade 2 using the Division of Microbiology and Infectious Disease grading system (DMID) except for haemoglobin and hypokaliaemia for which the limit values are: | |
Potassium <3.0 mEq/L (>grade 1) | |
Haemoglobin < 6.5 gm/dl | |
Separate criteria are required for glycaemia, as listed above | |
Any other finding considered by the investigator as compromising the participation of the patient in the trial | |
Any condition rendering the patient unable to understand the nature, scope, and possible consequences of the trial and to provide consent | |
Participation in another drug trial within the 3 months before the screening visit |