None listed
Conditions
Interventions
Treatment A Type of group
Cefepime: 1g or 2g IV twice or three times a day in moderate or severe infections, respectively, for the treatment of the infections described.
Group name:Treatment B Type of group
Scheme I
Ampicillin 2 to 3 g IV four times a day (8 to 12 g daily)
plus / less
Gentamicin 80 mg IV two or three times a day
(or amikacin 500 mg IV three times a day in case of suspicion
of Pseudomonas aeruginosa).
OR
Cefalotin 2 to 3g IV four times a day (8 to 12 g daily)
plus / less
Gentamicin 80 mg IV two or three times a day
(or amikacin 500 mg IV three times a day in case of suspicion
of Pseudomonas aeruginosa).
Scheme II
Ceftriaxo
Sponsors
BRISTOL MYERS SQUIBB PERÚ S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Age 18 years or older; • The subject or their legally authorized representative who has given their informed consent to participate in the study. • All women with the potential to conceive should have a documented pregnancy test in serum or urine, with a negative result and a minimum sensitivity of 25 IU / 1 human chorionic gonadotropin (BHCG), obtained within 48 hours prior to start of study drug administration (see Appendix I); Women with potential to conceive (MCPC) are those who have experienced menarche and have not undergone surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or are not in postmenopause [defined as amenorrhea for 12 consecutive months or more ; women who are receiving hormone replacement therapy (TSH) with a documented plasma level of follicle-stimulating hormone (FSH)> 35 mlUl / ml]. Women who are using oral contraceptive, implant or injectable hormones or mechanical products such as intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy; who practice abstinence or whose partner is sterile (for example, vasectomy) will be considered as women with potential to conceive. • Patients requiring hospitalization or patients who have been hospitalized for less than 3 days; • Patients with a score of> 5 and 38 ° C or I00.4 ^ F) -leukocytosis (> 10,000 leukocytes / mm ^ or> 15% in bands) -cough purulent sputum (> 25 PMN and 10 leukocytes / hpf obtained from centrifuged urine collected by the sterile collection technique or by catheterization, and two of the following conditions: -Fever (> 38.0 ° C or 100.4 ° F); -Leukocytosis (> 10,000 leukocytes / mm ^ or> 15% in bands); - Symptoms of the upper tract (pain in the side or back or abnormal sensitivity of the costovertebral angle). The history of recurrent urinary tract infections and known urological complications (such as kidney stones, obstruction, neurogenic bladder, prostatic hypertrophy) should be recorded in the case report form. Sepsis Clinical evidence of sepsis verified by; • Fever (> 38.0 ° C or 100.4 ° F) or hypothermia ( 90 Ipm; • Leukocytosis (> 12,000 leukocytes / nim ^ o> 10% band forms) or leukopenia ( 20; • PAC02 25 Ipm, or an increase of 15 Ipm, above the baseline value of the patient during 4 hours, in
Exclusion criteria
Exclusion criteria: • Pregnancy and / or lactation; • Patients with scores of 19 in the Apache II classification system • A life expectancy of less than 3 days or patients who have been placed in a no resuscitate state; • History of type I reaction or anaphylactic reaction to penicillins and / or to any of the study drugs (Cephalosporins of 1, 2, 3 or 4 ^ generation, aminoglycosides, macrolides, metronidazole and vancomycin). • Current, clinically significant liver disease (ie, ALT and / or AST and / or total bilirubin> 5 times the normal maximum limit); • Chronic renal failure (such as, for example, patients with a serum creatinine level> 3.0 mg / dl or who require renal dialysis); • Patients requiring intubation for respiratory support (except for patients who require intubation for the administration of surgical anesthesia); • Any other condition or therapy that, in the opinion of the Investigator or as indicated on the product label, could entail a risk to the patient or interfere with the objectives of the study; • Administration of any other investigational medication within 30 days prior to the start of treatment, and participation in other clinical studies at the same time as in this protocol; • Any other condition for which, in the opinion of the investigator, the patient is not eligible to be admitted to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The success rates will be compared with the initial Cefepima and with other broad-spectrum antibacterial therapy. Subjects who are cross-transferred to the other treatment group or who discontinue the study drug administration after 3 days because of low clinical response will be analyzed as failure cases. The analysis will be based on all clinically evaluable subjects. Measure:Primary Efficacy Analysis Timepoints:At the post-treatment visit (7 to 10 days after treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The bacteriological eradication rates of the study treatment in the population formed by all the evaluable subjects with a pretreatment pathogen will be compared. Measure:Secondary Efficacy Analysis Timepoints:On the last visit ; Outcome name:The incidence of adverse clinical events, abnormal laboratory events, and causes of discontinuation of the study medication will be examined. All subjects who receive at least one dose of study medication will be included in this tabulation. Measure:Safety Timepoints:On all of the visits | — |
Countries
Argentina, Brazil, Mexico, Peru
Outcome results
None listed