Clinical trial NCT00463801: Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections
Official title: A Multicentre, Open Label, Uncontrolled Clinical Trial to Evaluate Efficacy and Safety of Daptomycin for the Treatment of Complicated Skin and Skin-Structure Infections (cSSTI) Caused by Methicillin-resistant Staphylococcus Aureus (MRSA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Staphylococcal Skin Infections
Keywords: Complicated Skin and Skin-Structure Infections, Daptomycin, MRSA, Diabetic Foot, Abscess, Cellulitis
Complicated skin and skin-structure infections
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-04-20
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of daptomycin against complicated skin and skin-structure infections in adults


Eligibility criteria: Inclusion criteria:

* Subjects with a diagnosis of complicated skin and skin-structure infections (cSSTI) defined as infection normally requiring surgical/local debridement of sufficient severity to warrant hospitalization and intravenous antimicrobial treatment
* Infection to be due to Gram-positive bacteria
* Hospitalized subjects
* Written informed consent
* Female patients of childbearing potential must have a negative pregnancy test urine or serum at baseline and must use effective contraception throughout the study period.

Exclusion criteria:

* Complicated skin and skin-structure infections of the following categories:
* Infected burns
* Severely impaired arterial blood supply
* Decubitus ulcers
* Infected diabetic foot ulcers associated with osteomyelitis
* Infected human or animal bites
* Perirectal abscess
* Necrotising fasciitis or gangrene
* Infections expected to require more than 14 days of intravenous antimicrobial therapy
* Skin and/or skin structure infection that can be treated by surgery alone
* Infections associated with a permanent prosthetic device that will not be removed within 2 days of study enrollment
* Uncomplicated skin or soft tissue infection
* Documented bacteremia at baseline
* Concomitant infection nearby the site of infection at baseline, potentially interfering with the evaluations
* Hospitalization for conditions related to rhabdomyolysis
* Human immunodeficiency virus (HIV) with cluster of differentiation (CD) \< 200 or \< 14%
* Immune function alterations
* Lack of sufficient purulent material for culture and Gram test
* Systemic or local antibiotic administration with known anti-Gram positive activity in the preceding 48 hours
* Complicated skin and soft tissue infections (cSSTI) known or believed to be related to fungal, parasitic or viral infection
* Pneumonia
* Local or systemic known or suspected allergy to daptomycin
* Creatinine clearance \< 30 mL/min
* Severe liver damage (Child-Pugh class C) or Alanine transaminase (ALT) and/or Aspartate aminotransferase (AST) \> 3 x Upper limit of normal (ULN) and/or bilirubin \> 1.5 x ULN
* Use of any experimental drugs in the preceding 30 days
* Severe medical conditions that in the investigator's opinion could counter indicate participation in the study

Primary outcomes:
measure: Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start
timeFrame: at Day 7 and 14
Secondary outcomes:
measure: Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria
timeFrame: At day 4, 7, 10 and 14
measure: Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10
timeFrame: At day 4 and 10
measure: Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous
timeFrame: At day 14
measure: Efficacy Assessed by Time of Resolution of Infection
timeFrame: At day 14
measure: Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE
timeFrame: At day 14
measure: Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)
timeFrame: at day 14 and follow up day i.e. day 30
Other outcomes:
Locations:
city: Novartis Italy
country: Italy
facility: Novartis Italy
city: Saronno
country: Italy
facility: Novartis Italy
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: