Skip to main content

Table 2 Inclusion and exclusion criteria

From: A pivotal registration phase III, multicenter, randomized tuberculosis controlled trial: design issues and lessons learnt from the Gatifloxacin for TB (OFLOTUB) project

Inclusion criteria Patients eligible for inclusion in the trial must fulfil all of the following criteria:
  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
   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