Clinical trial NCT01184872: Study to Compare Efficacy and Safety of Daptomycin in Elderly Patients With Complicated Skin and Soft Tissue Infections
Official title: An Open Label, Multi-center, Randomized, Comparative Phase IIIb Study to Compare Efficacy and Safety of Intravenous (i.v.) Daptomycin With That of Semi-Synthetic Penicillins (SSPs) or Vancomycin in the Treatment of Elderly Patients (Aged ≥ 65 Years) With Complicated Skin and Soft Tissue Infections (cSSTI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infections
Keywords: Skin infection
Daptomycin
Elderly
Gram positive
Complicated skin and soft tissue infections
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-08-19
Enrollment: 120
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.


Eligibility criteria: Inclusion criteria:

Patients 65 years or older with infection of sufficient severity to require in-patient hospitalization, with parenteral antimicrobial therapy for at least 96 hours.

Patients who have a diagnosis of Gram-positive complicated Skin and Soft Tissue Infections (cSSTIs) with or without bacteremia:

* Wound infections,
* Major abscesses with or without recognized preceding trauma, that require antibiotic therapy in addition to surgical incision and drainage,
* Severe carbunculosis,
* Infected ulcers (except patients with multiple infected ulcers) associated with: diabetes, vascular insufficiency, pressure (i.e., decubitus ulcers).

Exclusion criteria:

Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (e.g., amputation).

Minor or superficial skin infections (e.g., furuncles, simple abscesses, acne, impetigo).

Cellulitis, including erysipelas, not associated with complicating factors. However, patients with cellulitis associated with more serious infection (e.g., surgical wound, diabetic ulcer, deep tissue) can be enrolled (proportion of these patients will be limited to 30%).

Infections for which outcome is difficult to assess:

* Perirectal abscess,
* Hidradenitis suppurativa,
* Gangrene,
* Infected human or animal bites,
* Multiple infected ulcers at distant sites,
* Infected burns (only third degree burn wound or wound area of more than 10 cm diameter),
* Conditions requiring emergency surgery including necrotizing fasciitis.

Medical conditions:

* History of significant allergy or intolerance to Vancomycin or Daptomycin. Hypersensitivity to SSPs penicillins is not an exclusion criterion,
* Concomitant clinically suspected or confirmed other site of infection or disorder at study entry that may interfere with the evaluation in this protocol,
* Infections associated with a permanent prosthetic device that will not be removed within 24 hours after enrolment,
* Known or suspected HIV infection with a CD4+ T-cell count \< 500/μL (HIV testing is not required),
* Severe hepatic disease (Child-Pugh Class C) or ALT and/or AST \> 5 times ULN and/ or total bilirubin \> 2 times ULN at screening,
* Calculated creatinine clearance by the Cockcroft-Gault equation using actual body weight \< 30 mL/min or any type of dialysis,
* Treatment with any investigational agent or device within 30 days of study drug administration.

Exclusion criteria related to medications:

* Previous systemic antibacterial therapy for the treatment of Gram-positive complicated skin and soft tissue infections for more than 24 hours within 48 hours prior to the day of first infusion of study drug unless:
* The previous antibacterial therapy was administered for 3 or more calendar days with either worsening or no improvement in the clinical signs and symptoms of cSSTIs, and was not Vancomycin or SSPs.

Other protocol-defined inclusion/exclusion criteria applied.

Primary outcomes:
measure: Number of Patients With Clinical Success at the Test-Of-Cure (TOC) Visit
timeFrame: Baseline and 7 to 14 days after end of therapy
Secondary outcomes:
measure: Number of Participants With Microbiological Response at Test-of-Cure (TOC) Visit
timeFrame: Baseline and 7 to 14 days after end of therapy
measure: Duration of Treatment (Intravenous)
timeFrame: Up to 28 days
measure: Duration of Treatment (Intravenous and Oral)
timeFrame: Up to 28 days
measure: Number of Patients With Adverse Events, Serious Adverse Events and Death
timeFrame: Continuously from baseline up to 28 days after end of antibiotic treatment.
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Novartis Investigative Site
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Homburg
country: Germany
facility: Novartis Investigative Site
city: Magdeburg
country: Germany
facility: Novartis Investigative Site
city: Mannheim
country: Germany
facility: Novartis Investigative Site
city: Muenster
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Pisa
country: Italy
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site (1)
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site (2)
city: Yaroslavi
country: Russian Federation
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site (1)
city: Santander
country: Spain
facility: Novartis Investigative Site
city: Seville
country: Spain
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmceuticals
name: Novartis Pharmceuticals
role: STUDY_DIRECTOR
References:
citation: Arbeit RD, Maki D, Tally FP, Campanaro E, Eisenstein BI; Daptomycin 98-01 and 99-01 Investigators. The safety and efficacy of daptomycin for the treatment of complicated skin and skin-structure infections. Clin Infect Dis. 2004 Jun 15;38(12):1673-81. doi: 10.1086/420818. Epub 2004 May 20.