A Phase IIIb, Randomized, Double-Blind, Multicenter, Parallel Group Studyto Assess the Efficacy and Safety of Oral Gemifloxacin 320 mg Once Dailyfor 5 Days Versus Oral Gemifloxacin 320 mg Once Daily for 7 Days for theTreatment of Mild to Moderate Community Acquired Pneumonia

Conditions: Mild to moderate community acquired bacterial pneumonia.
MedDRA version: 7.0Level: LLTClassification code 10010120

Registration Number: EUCTR2004-002619-10-CZ

Lead Sponsor: Oscient Pharmaceuticals

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 459

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

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).