Phase III controlled, double-blind, randomized study of Ziracin ™ (SCH 27899) compared to Vancomycin for the treatment of complicated infections originating in the skin or annexed by gram-positive pathogens.
- Conditions
- L089-L089 Local infection of skin and subcutaneous tissue, unspecifiedLocal infection of skin and subcutaneous tissue, unspecified
- Registration Number
- PER-014-00
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Adults (age> 18 years) of both sexes and of any race;
• They must present systemic or localized signs / symptoms of infection at the start:
• Systemic signs / symptoms: One (1) or more of the following results present within 24 hours of onset:
• Fever: oral temperature (T)> 38 ° C (100.4 ° F): tympanic>> 38.5 ° C (101.2 ° F): or rectal T> 39 ° C (102.2 ° F) or hypothermia (rectal / central T
• Hypotension: systolic blood pressure <90 mmHg on one or more occasions, considered abnormal by the investigator.
• Tachycardia: pulse> 100 beats / minute or an increase of 20 beats / minute with respect to the base value! previous if the subject receives beta-blockers or treatment with calcium channel blockers; Abnormal peripheral white blood cell counts: total leukocytes> 10,000 / mm ^ or ^ 500 / mm ^ or> 15% band neutrophils (immature);
•Shaking chills:
• Tachypnea: respiratory rate> 20 breaths per minute.
• O
• Two (2) or more localized signs / symptoms of complicated skin infection and attachments present at onset:
• Edema, induration, pustules, ulcers, purulent material release, localized pain / sensitivity to touch or pressure, abnormal heat at the site, generalized or localized redness, lymphangitic striae, or regional lymphadenopathy.
• Subjects are likely to require a prolonged cycle (> 3 days) of parenteral antimicrobial therapy to achieve a successful outcome: that is, subjects have a significant underlying vascular disease (eg arterial or venous insufficiency, diabetes mellitus or lymphatic disorders) significant) that complicate the natural history of skin infection or adnexa, or require surgical treatment (s) in addition to antimicrobial therapy (the patient is not a candidate for oral therapy).
• Vancomycin is clinically indicated for the treatment of complicated CSSI:
• Cellulitis or erysipelas: closed infections in the appendages of the skin probably caused by gram-positive pathogens;
• infections in post surgical wounds: of surgical procedures
• clean (thoracostomy, orthopedic procedures such as external fixation or joint replacement without evidence of bone or joint space compromise, reconstructive flaps, mastectomy, skin biopsies, appendices, or lymph nodes.
• Deep soft tissue infections: includes pyomyositis or panniculitis due to gram-positive organisms; abscesses subsequent to the use of the drug injection or trauma; or secondary cellulitis to the IV catheter that appears> 24 hours after it has been removed, without evidence of phlebitis.
• Chronic wounds: in which it is suspected that the only or predominant pathogens are gram-positive. This diagnosis includes diabetic foot ulcers, chronic vascular insufficiency ulcers and decubitus ulcers on the extremities or thorax (located on the outside of the sacrum or the ischium, diaper area).
• The subject is willing to participate in this study and to complete the follow-up evaluations.
• Capacity of the subject or its corresponding legal representative to give written informed consent.
• The subject must agree to use an effective method of contraception during the course of the study.
• Antibiotics
o Pre-treatment with investigational drugs (including experimental biological agents but excluding treatment with Synercid or Linezolid) within 30 days prior to randomization.
o The subject has received treatment with Ziracin within 30 days prior to randomization.
o Pre-treatment for CSSI by gram-positive pathogens: said subjects will be excluded unless they meet the following eligibility criteria to participate in this study:
• ¡) Subjects must have received <24 hours of antimicrobial treatment OR
• ii) Subjects present clinical evidence of treatment failure with documented gram-positive pathogens (GPP) isolated from primary site cultures obtained at the start ^ or earlier
• iii) Subjects present evidence of gram-positive infection resistant to the original treatment regimen (eg, MRSA isolates after initial cephalosporin therapy).
o Requirement of antimicrobial therapy for infection at any site other than the CSSI site (ie, evidence of a secondary site of infection).
o Requirement of aminoglycosides as concomitant treatment (for polymicrobial CSSI).
• Immunity
o 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.
o Severely neutropenic patients (<200 PMN cells / mm).
o Other syndromes of acquired or congenital immunodeficiency with a documented history of difficulties for the elimination of bacterial pathogens despite the administration of appropriate antimicrobial treatments.
• Severity of the disease
o High suspicion that surgical debridement and / or removal of the foreign body alone will resolve the infection by gram-positive pathogens.
o Infections that require prolonged treatment (more than 21 days of IV treatment) eg. endocarditis, infections related to prosthetic devices, or osteomyelitis.
o Dying with high probabilities of death during the first 48 hours due to underlying disease (s) in addition to infection by gram-positive pathogens.
o Subjects with evidence of necrotizing infection (fasciitis or gangrene) or other underlying conditions (eg, atopic dermatitis) that may impede the evaluation of the antimicrobial effect of the study drug.
o Unstable renal function that may or may require dialysis initiation during the course of treatment. Subjects with stable renal insufficiency or permanent dialysis treatments may enter the study.
• Others: Pregnant or breastfeeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method