A Multicenter Comparative Study of Cefepime Versus Broad-Spectrum Antibacterial Therapy in Moderate and Severe Bacterial Infections

Not Applicable

• Conditions: -J189 Pneumonia, unspecified-N390 Urinary tract infection, site not specified; Pneumonia, unspecified; Urinary tract infection, site not specified; J189; N390

• Registration Number: PER-032-99
• Lead Sponsor: BRISTOL MYERS SQUIBB PERÚ S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 1999-05-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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 <19 in the APACHE II classification system

Pneumonia
The diagnosis of pneumonia requires clinical evidence of pneumonia verified by the presence of a new infiltrate or infiltrates on the chest radiograph and two or more of the following characteristics:
-fever (> 38 ° C or I00.4 ^ F)
-leukocytosis (> 10,000 leukocytes / mm ^ or> 15% in bands)
-cough
purulent sputum (> 25 PMN and <10 squamous epithelial cells per low power field)
- chest pain
- abnormal auscultatory findings, such as rales or egophony
- scumbag
- headache
- general discomfort

Infection of the urinary tract
The diagnosis of urinary tract infection requires the isolation of> 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 (<36.0 ° C);
• Tachycardia> 90 Ipm;
• Leukocytosis (> 12,000 leukocytes / nim ^ o> 10% band forms) or leukopenia (<4,000 leukocytes / mm ^);
• Respiratory frequency> 20;
• PAC02 <32 mmHg
• Evidence or suspicion of infection elsewhere, and at least one of the following characteristics:
- Hypotension (reduction of systolic and diastolic pressures by 20 mmHg
and 10 mmHg, respectively, below the baseline value of the patient for at least 8 hours in the absence of another evident cause in addition to sepsis);
- Oliguria (<15 ml / hr of urine for 4 hours);
-Hyperventilation (respiratory rate> 25 Ipm, or an increase of 15 Ipm, above the baseline value of the patient during 4 hours, in

Exclusion Criteria

• Pregnancy and / or lactation;
• Patients with scores of <5 or> 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified