None listed
Conditions
Interventions
BMS-284756 Type of group
BMS-284756, 400 mg PYO once a day for 7-10 days
Group name:Claritromicin Type of group
Clarithromycin 500 mg PYO twice a day for 7-10 days
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Men or women 18 years of age or older, in whom oral therapy is indicated, with clinical evidence of community-acquired pneumonia. • The subject or his legally authorized representative have granted written informed consent • Women of childbearing age (MEF) must have a negative pregnancy test in serum or urine (minimum sensitivity of 25 IU / L or equivalent units of HCG) made within 48 hours immediately prior to the start of study drug administration .
Exclusion criteria
Exclusion criteria: • Subjects who have received more than a single dose of any systemic antibiotic (or a single dose of a combination of antibiotics, such as a cephalosporin plus a macrolide) within 7 days immediately prior to admission, or who may receive other systemic antibiotics during your participation in the study; • Subjects who, in the opinion of the Investigator, will require long-term antibacterial therapy (ie, for more than 10 days) or hospitalization to receive intravenous therapy to treat the underlying infection; • Subjects with previously diagnosed conditions that tend to imitate or complicate the course and evaluation of the infectious process (for example, known bronchial obstruction in addition to asthma or COPD, history of postobstructive pneumonia, cystic fibrosis, active lung malignancy); • Known active tuberculosis or suspected active tuberculosis, or infection with other mycobacteria or fungi; • Pneumonia known or suspected of Pneumocystis carinii pneumonia; • Previously diagnosed disease or diseases of immune function (eg, AIDS, current neutrophil count 3 times the normal maximum limit; • Subjects receiving chronic systemic steroids (ie,> 2 weeks) at a dose of> 10 mg prednisone per day (or its equivalent), or other chronic immunosuppressive therapy; • Known renal insufficiency (eg, serum creatinine> 2.0 mg / dL (176.7 pmoI / L) or requiring renal dialysis; • Subjects with empyema; • Subjects with primary lung abscess; • Infection acquired in a hospital, asylum or other institution of long-term care, or hospitalization for any reason in the previous 14 days; • History of serious hypersensitivity reaction (eg, urticaria, anaphylaxis) to any quinolone or macrolide compound; • Subjects receiving terfenadine, cisapride or astemizole; • Malabsorption syndromes or other gastrointestinal disorders that could affect the absorption of the medication; • Use of a research agent concomitantly or within 30 days prior to admission in this study; • Have been previously admitted to any study with BMS-284756; • Pregnancy and / or lactation; Y • Presence of any disorder or disease that may interfere with the evaluation of the study medication and / or due to which, in the opinion of the Investigator, it would not be appropriate to admit the subject in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation. Comparison of the clinical cure rates between the BMS-284756 and azithromycin regimens Measure:Efficacy of BMS-284756 Timepoints:5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Hematology: Hemoglobin, Hematocrit, Leukocyte count, and 5-part differential including neutrophils immature, platelets Serum chemistry: AST (TGO), ALT (TGP), total bilirubin, direct bilirubin, alkaline phosphatase, amylase, creatinine, glucose, urea nitrogen (ÑUS), electrolytes (sodium, potassium, chloride, bicarbonate / C02) Measure:Safety Timepoints:Laboratory tests will be conducted within 48 hours prior to the start of study therapy and at the intervals indicated during and after study drug administration. ; Outcome name:Sputum Smear and Evaluation; Sputum Culture Eradication: Absence of the original pathogen from the culture of a sputum sample of good quality (ie <10 epithelial cells / low frequency field) obtained in the evaluation of the Healing Test. Persistence: Continuous presence of the original pathogen in the culture of a purulent sputum sample obtained in the Healing Test Visit. Measure:Bacteriological eradication of the pathogen. Timepoints:Pre-treatment, during treatment and after treatment ; Outcome name:Evaluation of signs and symptoms Measure:Time to improvement of the symptoms Timepoints:Pre-treatment, during treatment and after treatment ; Outcome name:Evaluation of signs and symptoms Measure:Time to resolution of the symptoms Timepoints:Pre-treatment, during treatment and after treatment ; Outcome name:Assessment of Activity and Function Measure:Time for restoration of baseline functional status Timepoints:Pre-treatment, during treatment and after treatment ; Outcome name:Assessment of Time Lost from Work Measure:Time lost from work or other usual activities Timepoints:Pre-treatment, during treatment and after treatment ; Outcome name:Assessment of Health care Resource Use Measure:Total health care resource use, including treatments used for the treatment of adverse events, for the entire follow-up period, Timepoints:Pre-treatm | — |
Outcome results
None listed