A PHASE III, MULTICENTRE, RANDOMISED, DOUBLE-BLIND, COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CEFTAROLINE FOSAMIL (600 MG EVERY 8 HOURS) VERSUS VANCOMYCIN PLUS AZTREONAM IN THE TREATMENT OF PATIENTS WITH COMPLICATED BACTERIAL SKIN AND SOFT TISSUE INFECTIONS WITH EVIDENCE OF SYSTEMIC INFLAMMATORY RESPONSE OR UNDERLYING COMORBIDITIES

Not Applicable

• Registration Number: PER-029-12
• Lead Sponsor: AstraZeneca AB,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-17
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

1. PATIENT MUST PROVIDE A SIGNED WRITTEN INFORMED CONSENT PRIOR TO ANY STUDY-SPECIFIC PROCEDURES
2. PATIENT MUST BE A MALE OR FEMALE, AGED 18 YEARS AND OLDER
3. PATIENT MUST HAVE ONE OF THE FOLLOWING CSSTIS:
• CELLULITIS: A DIFFUSE SKIN INFECTION CHARACTERISED BY SPREADING AREAS OF ERYTHEMA, OEDEMA, AND/OR INDURATION OF A MINIMUM SURFACE AREA OF 75 CM2 (EG, MINIMUM LENGTH OF 10 CM AND WIDTH OF7.5 CM)
• TRAUMATIC OR SURGICAL WOUND INFECTION: AN INFECTION CHARACTERISED BY PURULENT DRAINAGE/OR COLLECTION FROM AN INJURY-RELATED WOUND OR A SURGICAL WOUND WITH SURROUNDING ERYTHEMA, OEDEMA, AND/OR INDURATION OF A MINIMUM SURFACE AREA OF 75 CM2 (EG, THE SHORTEST DISTANCE OF REDNESS, OEDEMA, AND/OR INDURATION EXTENDING AT LEAST 5 CM FROM THE PERIPHERAL MARGIN OF THE WOUND). APPROPRIATE SURGICAL INTERVENTION MUST BE COMPLETED PRIOR TO THE FIRST DOSE OF STUDY DRUG OR UP TO, AT MOST, 48 HOURS AFTER THE FIRST DOSE OF STUDY DRUG.

Exclusion Criteria

1. PATIENT IS INVOLVED IN THE PLANNING OR CONDUCT OF THE STUDY (APPLIES TO BOTH ASTRAZENECA/PPD, INC [PPD] STAFF AND STAFF AT THE STUDY SITE)
2. PATIENT HAS PREVIOUSLY ENROLED OR BEEN RANDOMLY ASSIGNED INTO THE PRESENT STUDY
3. PATIENT HAS PARTICIPATED IN ANOTHER CLINICAL STUDY WITH AN INVESTIGATIONAL DRUG OR INVESTIGATIONAL DEVICE DURING THE LAST 30 DAYS
4. PATIENT HAS RECEIVED SYSTEMIC ANTIBACTERIAL DRUGS FOR >24 HOURS WITHIN 96 HOURS PRIOR TO FIRST DOSE OF STUDY DRUG. PATIENTS WHO HAVE RECEIVED ANTIBIOTICS FOR >24 HOURS MAY BE ENROLED UNDER THE FOLLOWING CIRCUMSTANCES:
• THE CLINIC NOTES OBJECTIVELY DOCUMENT THE CLINICAL PROGRESSION OF CSSTI (IE, NOT BY PATIENT HISTORY ALONE), OR
• PATIENT RECENTLY COMPLETED A TREATMENT COURSE WITH AN ANTIBACTERIAL DRUG FOR AN INFECTION OTHER THAN CSSTI AND THE DRUG DOES NOT HAVE ANTIBACTERIAL ACTIVITY AGAINST BACTERIAL PATHOGENS THAT CAUSE CSSTI
5. PATIENT HAS UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS SUCH AS A SIMPLE ABSCESS, IMPETIGO, FURUNCULOSIS, OR FOLLICULITIS OR OTHER UNCOMPLICATED INFECTIONS (EG, PATIENTS WITH INFECTIONS EXPECTED TO IMPROVE WITH SIMPLE INCISION AND DRAINAGE).

Study & Design

• Study Type: Interventional
• Study Design: Not specified