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Completed

NCT Number: NCT00772447

China Registration Study in Patients With Skin Infections

The objectives of this study is to evaluate the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared with that of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects with Complicated Bacterial Skin and Skin Structure Infection due to Gram-Positive Pathogens.

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Key information

Conditions

Skin Diseases Cellulitis Communicable Diseases Connective Tissue Diseases Disease Attributes Infections Infectious Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases, Infectious Skin and Connective Tissue Diseases Suppuration

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of inform consent
  • A diagnosis of of complicated skin and skin structure infection known or suspected to be due to Gram-positive bacteria
  • Diagnosis of bacterial skin and skin structure infection in the presence of some complicating factor, including infections involving deeper soft tissue or requiring surgical intervention, a pre-existing lesion or underlying condition affect healing

Exclusion criteria

  • Subjects known to have any bloodstream infection (including bloodstream infection caused by S. aureus). Subjects whose baseline blood cultures are positive for any clinically pathogenic organism ( including S. aureus ) should be discontinued from study
  • Minor or superficial skin infections, Infected "decubitus"ulcer, Perirectal abscess, Hidradenitis suppurativa, Myositis, Multiple infected ulcers at distant sites, Infected burn wounds of a large area,
  • Conditions requiring surgery that in and of itself would cure the infection or remove the infected site (eg, amputation)
  • Conditions requiring emergent surgical intervention at the site of infection (eg, progressive necrotizing infections)

Treatment and study plan

daptomycin

Drug

4mg/kg IV ; Q 24 hr (once every 24 hours)

Other names: Cubicin®

Vancomycin

Drug

Vancomycin - 1g per 12 hrs, for 7-14 days

Or switch to

Vancomycin Followed by Semi-synthetic Penicillin-Cloxacillin:

  • 1 g every 6 hours or 2 g every 8 hours

Primary outcomes

  1. Change of Erythrocyte Volume Fraction(Percentage of Erythrocyte Volume in Total Volume of Blood)

    Time frame: baseline to TOC(test of cure), for up to 4 weeks

    Erythrocyte volume fraction means under certain conditions, after centrifugation pressing, the percentage of erythrocyte volume in the total volume of blood

  2. Change in Creatinine Clearance

    Time frame: baseline to TOC(test of cure), for up to 4 weeks

  3. Change in Serum Total Creatine Phosphokinase (CPK)

    Time frame: baseline to TOC(test of cure), for up to 4 weeks

  4. Change in Urine pH

    Time frame: baseline to TOC(test of cure), for up to 4 weeks

  5. Shift in ECG

    Time frame: baseline to TOC(test of cure), for up to 4 weeks

    percentage of patients who were primarily tested as normal ECG at baseline and changed into abnormal ECG at TOC visit in all the patients with normal ECG at baseline

Secondary outcomes

  1. Blinded Investigator's Assessement of Clinical Response at TOC(Test of Cure)

    Time frame: baseline and TOC, for up to 4 weeks

    The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population of each arm at TOC visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)

  2. Blinded Investigator's Assessement of Clinical Response at EOT(End of Therapy)

    Time frame: baseline and EOT(end of therapy), for up to 2 weeks

    The percentage of patients who were cured or clinically improved in the clinical evaluable (CE) population at EOT visit was analyzed. CE population includes all the patients with no significant deviation from study protocol in full analysis set population, and meetting the following specific criteria: 1.receiving randomly dispensed study treatment at appropriate time(with a compliance of at least 80% or 4 days [3 days for patients evaluated as treatment failure]). 2.without the administration of potentially confounding non-investigational antibiotics (using one potentially effective non-investigational antibiotic for the treatment of primary infection due to other reasons than lack of efficacy from Day 1 to TOC [for systemicadministration of non-glycopeptides, >1 calendar day]). 3.meeting the study inclusion/exclusion criteria 4.necessary clinical evaluation performed (evaluation for effectiveness at TOC visit, except for the condition confirmed as clinically ineffective)

  3. Microbiological Response at TOC(Test of Cure)

    Time frame: baseline and TOC, for up to 4 weeks

    The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at TOC visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at TOC visit in all the strains isolated from ME population at baseline.

  4. Microbiological Response at EOT(End of Therapy)

    Time frame: baseline and EOT, for up to 2 weeks

    The microbiological response rate (removal or presumed removal) in ME(microbiological evaluable) population of daptomycin group and comparator group at EOT visit was analyzed. ME population includes all the patients with Gram-positive pathogenic bacteria isolated at baseline in CE population. Microbiological response rate means the percentage of strains which were removed or presumably removed at EOT visit in all the strains isolated from ME population at baseline.

  5. Per-pathogen(Methicillin Resistant Staphylococcus Aureus) Clinical Response at TOC(Test of Cure)

    Time frame: baseline and TOC, for up to 4 weeks

    This is the comparison of clinical efficacy by methicillin resistant staphylococcus aureus(MRSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MRSA infection at baseline of both groups.

  6. Per-pathogen(Methicillin Sensitive Staphylococcus Aureus) Clinical Response at TOC

    Time frame: baseline and TOC(test of cure), for up to 4 weeks

    This is the comparison of clinical efficacy by methicillin sensitive staphylococcus aureus(MSSA) between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with MSSA infection at baseline of both groups.

  7. Per-pathogen(Staphylococcus Aureus) Microbiological Response at TOC

    Time frame: baseline and TOC(test of cure), for up to 4 weeks

    This is the comparison of clinical efficacy by staphylococcus aureus between the two groups. As the analysis was performed by specific pathogen in ME population and clinical efficacy was compared meanwhile, the clinical evaluation was based on the number of cases under the category of specific pathogen rather than the number of strains. Percentage of patients who were cured or improved at TOC visit in the patients who were identified with staphylococcus aureus infection at baseline of both groups.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Phase 3, Multicentre, Randomised, Investigator-blinded, Parallel-groupStudy of the Safety and Efficacy of Intravenous Daptomycin (Cubicin®)Compared With That of Comparator (Vancomycin or Vancomycin Followed by Semi-synthetic Penicillin-cloxacillin) in the Treatment of Chinese Subjects With cSSSI

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 15, 2008
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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