None listed
Conditions
Interventions
APPROXIMATELY 765 ADULT PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER WILL BE ELIGIBLE FOR THIS STUDY IF THEY HAVE EVIDENCE OF SYSTEMIC INFLAMMATORY RESPONSE OR UNDERLYING COMORBIDITIES AND PRESENT WITH C
Sponsors
AstraZeneca AB,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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).
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Czech Republic, France, Germany, Greece, Israel, Italy, Korea North, Mexico, Philippines, Poland, Romania, Russian Federation, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States
Contacts
Public ContactANDRES CESAR MARTIN BAYONA
PPD Peru S.A.C.
Outcome results
None listed