Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections

Staphylococcal Skin Infections Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00463801
• Other study ID #: CCBC134AIT01
• Status: Terminated
• Phase: Phase 4
• First received: April 19, 2007
• Last updated: March 22, 2011
• Start date: January 2007

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Skin Diseases, Infectious
• Staphylococcal Skin Infections

Intervention

Drug:
• Daptomycin

Locations

Country	Name	City	State
Italy	Novartis Italy	Novartis Italy
Italy	Novartis Italy	Saronno

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Participants With Clinical Success at the Day 7 (D7) and Day 14 (D14) Visit After Treatment Start	Primary objective of the study was to evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the day 7 and day 14 visit (D7, D14) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.	at Day 7 and 14	No
Secondary	Efficacy Assessed as Success After 4, 7, 10 and 14 Days of Treatment With Daptomycin on Infecting Gram Positive Bacteria	To evaluate the microbiological efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the proportion of patients achieving eradication of the Gram-positive baseline organisms at the study visits on D4, D7, D10, and D14. Microbiological success is documented eradication of baseline Gram-positive organism or presumed eradication defined as clinical success and no culture performed because of absence of drainage or other material for culture.	At day 4, 7, 10 and 14	No
Secondary	Efficacy Assessed as Percentage of Patients With Clinical Success at Day 4 and 10	To evaluate the efficacy of intravenous (IV) daptomycin in the treatment of complicated skin and soft tissue infections (cSSTI) caused by methicillin-resistant Staphylococcus aureus (MRSA), as assessed by measuring the clinical success rate achieved at the interim visits on day 4 (D4) and day 10 (D10) after treatment start. Clinical success is defined as complete resolution of signs and symptoms of infection, or clinical improvement, i.e. partial resolution of signs and symptoms so that no further antibacterial treatment was required.	At day 4 and 10	No
Secondary	Efficacy Assessed by Duration of Treatment With Daptomycin Intravenous		At day 14	No
Secondary	Efficacy Assessed by Time of Resolution of Infection	Time to resolution of signs and symptoms of infection, time to resolution of fever (oral or tympanic temperature =37.5°C).	At day 14	No
Secondary	Safety Assessed by Hematological and Biochemical Tests, Urinalysis, and Recording and Follow-up of Emerging AE and SAE		At day 14	Yes
Secondary	Evaluated Resource Utilization and Calculated Overall Treatment Cost (Including Treatment Period and Follow-up Period)		at day 14 and follow up day i.e. day 30	No