None listed
Conditions
Interventions
Group 1 Type of group
MS-284756 administered in a dose of 400 mg IV once a day for 7 to 14 days
Group name:Group 2 Type of group
Ceftriaxone 1 to 2 grams IV once a day for 7 to 14 days with or without the addition of erythromycin, at a rate of 0.5 to 1 gram every 6 hours
Sponsors
BRISTOL MYERS SQUIBB PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Patients recently hospitalized (that is, less than 24 hours), male or female, 18 years of age or older, with clinical evidence of moderate to severe community-acquired pneumonia, demonstrated by the following: 1) A new infiltrate in the chest X-ray; 2) Two or more of the following findings: a) Fever (> 38 ° C or 100.4 ° F orally, 102.1 ° F taken by the eardrum, or> 39 ° C or> 102.2 ° F taken rectally), b) Leukocytosis (> 10,000 white blood cells / mm ^ or> 15 abashed), c) Cough, d) Pleuritic pain, e) Auscultatory findings such as rales and / or evidence of pulmonary consolidation (eg, egophony, bronchial breath sounds, or dullness in percussion), g) Sputum production (if sputum is produced, a sample should be sent to the laboratory for Gram stain and culture for aerobic germs). • Written informed consent of the subject or an authorized legal representative • Women with child-bearing potential (WOCBP) should have a serum or urine test to detect pregnancy (minimum sensitivity, 25 International Units / L or its equivalent in HCG units) within the 48 hours before starting the medication under study.
Exclusion criteria
Exclusion criteria: • Subjects who have received more than one dose of any systemic antibiotic (or more than one dose of a combination of antibiotics, such as a cephalosporin plus a macrolide) within a period of 7 days prior to recruitment, or who are likely to receive other systemic antibiotics during your participation in the study; subjects receiving a systemic antifungal or antiviral agent for prophylaxis are eligible to enter the study and may continue with such medications • Subjects who, in the opinion of the investigator, may require long-term antibacterial therapy (for example, for more than 14 days) • Subjects with a terminal illness (defined as the subjects who will expire within the next 72 hours) or with a rapidly progressive underlying disease; which, in the opinion of the researcher, prevented the evaluation of the response to therapy • Previously diagnosed conditions that tend to resemble or complicate the course and evaluation of the infectious process (for example, a known bronchial obstruction apart from asthma or chronic obstructive pulmonary disease [COPD], history, of post-obstructive pneumonia, cystic fibrosis, malignancy active lung) • Active tuberculosis or suspicion of such condition, or any lung infection with other mycobacteria, fungi, parasites or viruses (patients with bacterial pneumonia after infection with influenza or other respiratory viruses are eligible) • Documentation or suspicion of Pneumocystis carini pneumonia • Diseases previously diagnosed of the immune function. (for example, AIDS, current neutrophil count 3 times the upper limit of normal; • Subjects on chronic treatment (eg, ^ week) with systemic steroids at a dose> 10 mg / day of prednisone (or its equivalent) or some other chronic immunosuppressive therapy • Documented renal insufficiency (eg, serum creatinine> 2.0 mg / dL (176.7 umol / L) or dialysis requirement) • Subjects with empyema • Subjects with a primary lung abscess • Infection acquired in the hospital or hospitalization for any reason within the previous 14 days [excluding the 24-hour period prior to recruitment] • History of any serious hypersensitivity reaction (eg, urticaria, anaphylaxis) to any quinolone, beta-lactam or macrolide; • Malabsorption syndromes or other gastrointestinal disturbances that affect the absorption of drugs • Concomitant use of an agent in research or in the 30 days prior to entering the study • Pre-recruitment in any study with BMS-284756 • Pregnancy and / or being breastfeeding • Any disorder or illness that could interfere with the evaluation of the drug under study and / or that in the opinion of the investigator made the subject unsuitable for recruitment; • Subjects under treatment with terfenadine, cisapride or astemizole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Signs and symptoms clinical test Measure:Comparison of clinical cure rates between regimens with BMS-284756 and ceftriaxone / clarithromycin at the visit to determine the cure Timepoints:days +7 to +14 or at the time of discontinuing the drug in the subjects who left the treatment prematurely | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Signs and symptoms clinical test Measure:Comparison of clinical cure rates between regimens with BMS-284756 and ceftriaxone / clarithromycin in all treated subjects, clinically eligible subjects and microbiologically evaluable subjects Timepoints:days +7 to +14 or at the time of discontinuing the drug in the subjects who left the treatment prematurely ; Outcome name:Culture results Measure:Summaries of the bacteriological eradication rates according to the pathogen in the microbiologically evaluable subjects Timepoints:After treatment ; Outcome name:Clinical evaluation of signs and symptoms Measure:Clinical cure rates in clinically evaluable subjects, which have an isolated pathogen before treatment Timepoints:Before and after treatment | — |
Outcome results
None listed