None listed
Conditions
Interventions
Ziracin 6 mg Type of group
Ziracin 6 mg / kg / day administered in the form of an IV Infusion of 60 minutes every day for the duration of the treatment phase of the study
Group name:Vancomicin Type of group
Vancomycin 15 mg / kg in the form of an IV infusion of 60 minutes every 12 hours or according to the nomogram based on the Cockcroft-Gault creatinine clearence estimate
Sponsors
SCHERING PLOUGH RESEARCH INSTITUTE,
Eligibility
Inclusion criteria
Inclusion criteria: • Male or female patients at least 18 years of age. • Microbiogenic evidence of gram-positive bacterial infection documented by Gram stain and / or culture of material taken from the infected site (eg fluid / pus aspirated, drainage, catheter tip, deep wound swab or tissue biopsy, etc.); or positive blood cultures within 72 hours of incorporation. • Clinical evidence of complicated infection related to the skin or adnexa or with IV catheter: for ex. location of signs of infection such as erythema, induration, abnormal sensitivity to touch or pressure, pus, drainage, etc. And systemic signs such as fever / hypothermia, bacteremia, leukocytosis or chills. • The ability of the patient or guardian designated to give written informed consent and complete all follow-up evaluations. • Expected survival> 7 weeks.
Exclusion criteria
Exclusion criteria: • Antibiotics • Preference for the use of aminglucosides and / or antibiotics against gram-positive as auxiliary treatment. • History of allergy or vancomycin intolerance. • Pre-treatment with agents in the research phase (including experimental biological agents) in the previous 30 days (excluding treatment with Synercid ™ or Linezolid) or any previous treatment with Ziracin ™. • Previous treatment with antibiotics for> 72 hours, unless the pathogen is resistant to previous antibiotic treatment. • Severity of the disease • No systemic signs or symptoms indicating infection. • High suspicion that surgical debridement and / or catheter removal alone will resolve the gram-positive infection. • Septic shock defined as sustained systolic hypotension (<90 mm Hg) or use of vasopressors for more than 3 hours. • Immunity • Induction chemotherapy within 2 weeks prior to incorporation or exogenous treatments that are expected to result in PMN counts of <200 / mm during the treatment phase. • Severely neutropenic patients (<200 PMN cells / mm ^). • Patients in whom, according to past experiences, the pathogens causing the infection persist at the end of antibiotic therapy. • Chronic granulomatous disease or other disorders of leukocyte function that may slow the elimination of bacteria. •Laboratory • Pathogens resistant to vancomycin or Ziracin. • Concomitant infection in other sites by different pathogens. •Others • Pregnant or breastfeeding women or women of childbearing age who do not use effective contraception. - • Infections of prosthesis materials: ex. Tunneled subcutaneous catheters (eg, catheter holder) • Infections requiring treatment - prolonged IV (more than 21 days) including endocarditis, infections related to prosthetic devices, osteomyelitis, empyema and visceral abscess • CNS infections, eg. meningitis, brain abscess.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Changes in creatinine levels during the treatment period with respect to baseline levels. A 95% confidence interval for double-tail test will be calculated for the toxicity index based on the normal approximation to a binomial distribution. Measure:Toxicity Evaluation Timepoints:During treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Effect of Ziracin on Day 14 after treatment on; Signs and symptoms of infection indicators of clinical response; The microbiological response; and The combined clinical and microbiological responses. Measure:Efficacy Timepoints:14 days ; Outcome name:Describe pharmacokinetics of Ziracin in patients receiving 6 mg / kg / day vs. 9 mg / kg / day. Measure:Pharmacokinetics Timepoints:During the study | — |
Contacts
Public ContactJorge Timoteo
SCHERING PLOUGH DEL PERÚ S.A.
Outcome results
None listed