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

• ClinicalTrials.gov Identifier: NCT00911573
• Recruitment Status: Withdrawn
• First Posted: June 2, 2009
• Last Update Posted: June 7, 2012
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information

• First Submitted Date: May 29, 2009
• First Posted Date: June 2, 2009
• Last Update Posted Date: June 7, 2012
• Study Start Date: August 2011
• Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 4, 2010): 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 ]
• Original Primary Outcome Measures (submitted: June 1, 2009): Tigecycline vs comparators clinical efficacy based on subject outcome: last day of intravenous therapy, test of cure, follow-up. The tolerability (safety) monitored: vital signs, adverse event, lab values, ECG, clinical signs/symptoms of the infection. [ Time Frame: 34-50 days ]

Current Secondary Outcome Measures (submitted: October 4, 2010)

• 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 ]

• Original Secondary Outcome Measures (submitted: June 1, 2009): Infection clearance: subject & pathogen response. Pharmacokinetic/pharmacodynamic. Susceptibility for a range of pathogens [ Time Frame: 34-50 days ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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
• Brief Summary: 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment

Condition

• Skin Diseases
• Infection

Intervention

• Drug: Tigecycline
  50 mg IV every 12 hours up to 14 days
  Other Name: Tygacil
• 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

Study Arms

• Experimental: A
  Tigecycline
  Intervention: Drug: Tigecycline
• Active Comparator: B
  Clindamycin (or Vancomycin if needed)
  Intervention: Drug: Clindamycin (or Vancomycin if needed)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: June 5, 2012): 0
• Original Estimated Enrollment (submitted: June 1, 2009): 400
• Estimated Study Completion Date: May 2014
• Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 8 Years to 17 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Korea, Republic of, Ukraine, United States

Administrative Information

• NCT Number: NCT00911573
• Other Study ID Numbers: 3074K4-3339; B1811002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
• Study Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Wyeth is now a wholly owned subsidiary of Pfizer
• Verification Date: June 2012