A phase II prospective, open label, randomized, active-controlled, parallel group, multi-center ‘proof of concept’ trial in adult patients with complicated skin and skin structure infections requiring hospitalization. - BEST

F. Hoffmann - La Roche AG0 sites300 target enrollmentStarted: July 26, 2006Last updated: October 9, 2012

Conditions

Trial Snapshot

Phase: Not Applicable
Status: Active, not recruiting
Sponsor: F. Hoffmann - La Roche AG
Enrollment: 300

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1. Informed consent has been signed by patient or has been signed by a legal representative recognized by the local authority
•2. Male or female patients =18 years of age with skin or skin structure infection requiring hospitalization
•3. If the patient is sexually active and is female of child bearing potential, or is a sexually active male who has a female partner of child bearing potential, then the patient agrees to use two forms of contraception, at least one of which is a barrier method, during the study period (Baseline to EOSE)
•4. If infection site is contiguous to bone or if septic thrombophlebitis is suspected, then an appropriate imaging modality [MRI, CT, bone scan] of the area must show no evidence of osteomyelitis/thrombophlebitis within 24 hours of randomization
•5. Appropriate culture specimen (obtained by tissue biopsy, deep culture, needle aspiration, incision and drainage, or curettage) has been obtained for culture and sensitivity prior to administration of IV study drug. If anaerobes are suspected the specimen must be transported to the local lab in appropriate transport media (or if material is aspirated with a syringe, air must be expelled, the needle recapped using a one hand technique and transported immediately to the local lab for processing). Alternatively, commercially available anaerobic transport swabs can be used.
•6. Patients must have a clinical diagnosis of one of the following skin and skin structure infections caused by bacteria known or suspected to be susceptible to the randomized study treatments
•a)extensive cellulitis (> 10 cm) and purulent drainage or purulent fluid collection demonstrating PMN’s and/or bacteria on Gram stain requiring parenteral antibiotics
•b)extensive abscess and infection of deep soft tissue requiring parenteral antibiotics and surgical incision and drainage or debridement [If clinical evidence of septic thrombophlebitis is present, then appropriate imaging to exclude septic thrombophlebitis is required within 24 hours of randomization.]
•c) post traumatic wound infection (without evidence of contiguous osteomyelitis)
•d) surgical site infection
•e) infected burn
•7. Material from the site of infection is clinically purulent or seropurulent
•8. The patient has received <24 hours of antibacterial therapy prior to study entry
•Patient has received = 3 days of prior antibiotic therapy and has clinical evidence of treatment failure (such evidence includes continued fever and the persistence of other symptoms consistent with skin and skin structure infections) and a Gram stain obtained by an acceptable method demonstrates bacteria
•The infecting organism is known to be resistant to the previous antibacterial therapy
•9. Have had a temperature > 37.5 °C oral or > 37.9 °C tympanic or > 38.3 °C rectal during the previous 24 hours
•10. Have at least two of the following:
•a) WBC count > 10,000 mm3 or with = 10% bands;
•b) local erythema;
•c) local swelling;
•d) tenderness;
•e) fluctuance;
•f) regional lymphangitis
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•1. Have presented with sustained shock, defined as systolic blood pressure < 90
•mm Hg for > 2 hours despite adequate fluid resuscitation, with evidence of
•hypoperfusion or the need of sympathomimetic agents to maintain blood pressure
•2. Are likely to be discharged in less than 3 days
•3. Require hemodialysis, peritoneal dialysis, plasmapheresis or hemoperfusion
•4. Have known or suspected osteomyelitis contiguous to the site of skin/skin structure
•5. Have known or suspected septic thrombophlebitis
•6. Have known or suspected fungal, mycobacterial, viral or parasitic infection
•7. Have an infected full thickness burn of any size or burn > 30% body surface area
•8. Are using or likely to use topical antibiotics (except for the routine care of
•intravascular catheters or indwelling bladder urinary catheters)
•9. Have received an investigational drug within one month prior to enrollment
•10. Have a known or suspected concomitant bacterial infection requiring antibiotic
•11. Have a skin infection or chronic non-healing ulcer > 2 weeks duration
•12. Are patients in whom surgery is the primary treatment, e.g. likely to require
•surgical extirpation of an infected artery, vein or arterial graft, amputation of the
•infected area or limb or necrotizing fasciitis. (Amputation of gangrenous toes
•adjacent to an infection site is permitted)
•13. Require chronic immunosuppressive therapy or have an anticipated need for
•immunosuppressive therapy for > 1 month from baseline (including > 10 mg/day of
•systemic prednisone or equivalent)
•14. Have any form of epilepsy or history of seizures
•15. Have hypersensitivity to ß-lactam antibiotics
•16. Have a history of a significant reaction to vancomycin and the site assigned
•comparator is vancomycin
•17. Have a history of significant hypersensitivity reaction to the initial Gram-negative
•antibiotic therapy (aztreonam or ciprofloxacin)
•18. Have a history of cerebrovascular accident, transient ischemic attack(s), brain
•metastases, space occupying lesion in the CNS or systemic malignancy within past
•year and/or are currently receiving adjuvant chemotherapy
•19. Have a creatinine clearance, using the Cockcroft-Gault equation, of = 80 mL/min
•20. Have significant proteinuria (4+ or > 1.0 % or 10 g/L on urinalysis)
•21. Have evidence of liver dysfunction manifested by: ALT or AST = 4X ULN or total
•bilirubin > 1.5X ULN
•22. Have neutropenia (ANC < 1000/mm3) or platelet count < 50,000/mm3
•23. Have a history of hemolytic anemia
•24. Is unlikely to comply with the dosing regimen, scheduled assessments, or complete
•the study for any other reason
•25. Have artificial heart valves, artificial joints or vascular prostheses
•26. Are receiving or likely to receive coumarin or probenecid therapy during the study
•27. Have known HIV infection or AIDS with a CD4 count < 250 cells/mm3 OR are taking antiretroviral therapy or in the opinion of the investigator should begin antiretroviral treatments or have undiagnosed HIV infection but have clinical findings highly suggestive of HIV
•28. Are pregnant or nursing
•29. Have any concomitant condition which could preclude evaluation of response or make it unlikely that a course of therapy and follow-up evaluations could be completed
•30. Have previously been randomized into this study or are ancillary personnel involved with this study

Investigators

Sponsor

F. Hoffmann - La Roche AG

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