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Study Evaluating Tigecycline Versus Clindamycin Or Vancomycin On Complicated Skin And Skin Structure Infections Including Those Due To Methicillin-Resistant Staphylococcus Aureus (MRSA) In Pediatric Subjects

This study has been withdrawn prior to enrollment.
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: May 29, 2009
Last updated: June 5, 2012
Last verified: June 2012
The main purpose of this study is to compare the safety and efficacy of tigecycline versus clindamycin (including subjects treated with vancomycin) in pediatric subjects (aged 8 to 17 years) with complicated skin and skin structure infections (cSSSI), including those caused by methicillin-resistant staphylococcus aureus (MRSA).

Condition Intervention Phase
Skin Diseases Infection Drug: Tigecycline Drug: Clindamycin (or Vancomycin if needed) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind Study To Evaluate The Safety And Efficacy Of Tigecycline Versus Comparator (Clindamycin Or Vancomycin) For The Treatment Of Complicated Skin And Skin Structure Infections, Including Those Due To MRSA, In Pediatric Subject Ages 8 To 17 Years Old

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Clinical response rate at the test-of-cure visit for the 2 co-primary populations: clinically evaluable and clinically modified intent to treat populations [ Time Frame: 15-37 days ]

Secondary Outcome Measures:
  • Microbiologic response at the subject level and at the pathogen level measured at intravenous last day of therapy (IV LDOT), test-of-cure (TOC) and follow-up (FUP) visits [ Time Frame: 5-49 days ]
  • Clinical cure rates by baseline pathogen (including MRSA) at test-of-cure (TOC) visit [ Time Frame: 15-37 days ]
  • Clinical response and microbiological response at the subject level for subjects with monomicrobial and polymicrobial infections at test-of-cure (TOC) visit [ Time Frame: 15-37 days ]
  • Development of decreased susceptibility [ Time Frame: 5-50 days ]
  • Clinical response and microbial response at subject level by baseline pathogen and minimum inhibitory concentration (MIC) values at test-of-cure (TOC) visit [ Time Frame: 15-37 days ]
  • Susceptibility data by pathogen [ Time Frame: 5-50 days ]

Enrollment: 0
Study Start Date: August 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Drug: Tigecycline
50 mg IV every 12 hours up to 14 days
Other Name: Tygacil
Active Comparator: B
Clindamycin (or Vancomycin if needed)
Drug: Clindamycin (or Vancomycin if needed)
For clindamycin 10mg/kg (not to exceed 900mg) IV every 8 hours up to 14 days. For vancomycin 15mg/kg (not to exceed 2g/day and adjusted as needed for renal impairment) IV every 8 hours


Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects 8 to 17 years old. Children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration.
  • Have a diagnosis of a serious infection requiring hospitalization and administration of IV antibiotic therapy.
  • complicated skin and skin structure infections (cSSSI) requiring significant surgical intervention or involving deeper soft tissue with the presence of at least one sign of systemic infection

Exclusion Criteria:

  • Subject with any concomitant illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and/or completion of the study, or could preclude the evaluation of the subject's response (e.g., life expectancy < 30 days).
  Contacts and Locations
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Please refer to this study by its identifier: NCT00911573

Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer Identifier: NCT00911573     History of Changes
Other Study ID Numbers: 3074K4-3339
Study First Received: May 29, 2009
Last Updated: June 5, 2012

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
Communicable Diseases
Skin Diseases
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on September 21, 2017