Mild to moderate community acquired bacterial pneumonia. MedDRA version: 7.0 Level: LLT Classification code 10010120
Conditions
Interventions
Trade Name: Factive TM
Product Name: Factive TM
Pharmaceutical Form: Capsule*
INN or Proposed INN: Gemifloxacin mesylate
CAS Number: 204519-65-3
Current Sponsor code: Gemifloxacin mesylate
Concentrati
Sponsors
Oscient Pharmaceuticals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients may be included in this study if the following criteria are met: 1. Patient is aged 18 years or more. 2. Patient has given written dated informed consent to participate in the study. 3. Patient has a clinical diagnosis of community acquired bacterial pneumonia characterised by fever (Fever defined as an oral temperature of 38°C or more, tympanic temperature of 38°C or more, or rectal temperature of 38.5°C or more) and at least two of the following signs and symptoms: _ -new or increased cough; _ -purulent sputum or a change in sputum characteristics; _ -auscultatory findings on pulmonary examination of rales and/or evidence of pulmonary consolidation (dullness on percussion, crackles on auscultation, bronchial breathing); _ -dyspnea; 4. Patients with a chest radiograph showing the presence of new or progressive infiltrate(s), consolidation, or pleural effusion consistent with pneumonia. 5. Patient is willing and able to comply with the study protocol. 6. Patient is expected to survive the duration of the study protocol. 7. Female patients of child-bearing potential have a negative urine pregnancy test prior to enrollment (including those who are practising birth control, those with tubal ligation and those less than one year post menopausal). NOTE: A serum pregnancy test will also be performed by the central laboratory on all female patients of child-bearing 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant, lactating, planning a pregnancy during the study, or of child-bearing potential and not using an accepted method of contraception (i.e. surgical sterility, intra-uterine contraceptive device, oral contraceptive plus barrier contraceptive, other hormone delivery systems plus barrier contraceptive, diaphragm or condom in combination with contraceptive cream, jelly or foam). 2. Patients with known or suspected hypersensitivity to quinolone antibacterials or not suitable for therapy as described in the contraindications, warnings or precautions sections of the Investigator’s Brochure for gemifloxacin for seven days. 3. Patients with a history of tendonitis while taking fluoroquinolones. NOTE: patients developing tendonitis during the study should be withdrawn. 4. Patients with hospital-acquired pneumonia (i.e., pneumonia acquired more than 48 hours after hospital admission) or who have been hospitalized within 2 weeks preceding entry into the study. 5. Patients with a pre-therapy chest radiograph negative for chest infiltrates, or inconsistent with a diagnosis of CAP. 6. Patients with aspiration pneumonia. 7. Patients with known localized bronchial obstruction or a history of postobstructive pneumonia (this does not exclude patients who have chronic obstructive pulmonary disease). 8. Patients with cystic fibrosis, active tuberculosis, bronchiectasis, or active pulmonary malignancies (with clinical signs and symptoms as opposed to a radiographic-only diagnosis). 9. Presence of a complicating infection or disease that would compromise treatment evaluation of the study medication (e.g. septic shock, empyema, septic arthritis, meningitis). 10. Patients with a life threatening or serious underlying disease, which is unstable. 11. Patients requiring parenteral antibacterial therapy. 12. Patients who have received more than 24 hours treatment with any other antibacterial for this current episode of CAP 13. Patients who are immunocompromised. 14. Patients who are known to be HIV positive and with a CD4 count with less than 500 cells/mm3 within the past 3 months. 15. Patients receiving systemic steroids at a dose of more than 10mg per day of prednisone (or the equivalent) 16. Patients with active alcohol or drug abuse. 17. Patients who are concurrently receiving sucralfate. 18. Treatment with an investigational drug, vaccine or device within 30 days or 5 half lives (whichever is longer) of study entry. 19. Patients who have been previously enrolled in this study or any other study involving gemifloxacin (except healthy volunteer studies).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that the clinical efficacy of oral gemifloxacin 320 mg once daily for 5 days is at least as good as oral gemifloxacin 320 mg once daily for 7 days, for the treatment of mild to moderate CAP. ;Secondary Objective: To evaluate the safety of oral gemifloxacin 320 mg once daily for 5 days, compared with oral gemifloxacin 320 mg once daily for 7 days, in patients with mild to moderate CAP. To evaluate the bacteriological efficacy of oral gemifloxacin 320 mg once daily for 5 days, compared with oral gemifloxacin 320 mg once daily for 7 days, in patients with mild to moderate CAP.;Primary end point(s): Primary Efficacy Evaluation: Clinical response (success or failure) at follow-up is the primary efficacy parameter. For patients who were 'clinical successes' at end of therapy, the investigator will review the clinical information obtained at the follow-up evaluation, and will evaluate each patient's clinical outcome as follows: Follow-Up Clinical Success: Sufficient improvement or resolution of signs and symptoms of CAP for patients who were clinical successes at the end of therapy visit, such that no additional antibacterial therapy is required for CAP. Clinical Recurrence: Reappearance of signs and symptoms of CAP for patients who were clinical successes at the end of therapy, such that additional antibacterial therapy is required for CAP. Unable to Determine: A valid assessment of clinical outcome could not be made (e.g. the patient was lost to follow-up or did not consent to a clinical examination). | — |
Countries
Czech Republic, Lithuania
Outcome results
None listed