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 - Full Text View

Purpose

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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:

MedlinePlus related topics: MRSA Skin Conditions

Drug Information available for: Vancomycin Vancomycin hydrochloride Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin palmitate hydrochloride Clindamycin palmitate Tigecycline

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
Clinical cure rates by baseline pathogen (including MRSA) at test-of-cure (TOC) visit [ Time Frame: 15-37 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Development of decreased susceptibility [ Time Frame: 5-50 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Susceptibility data by pathogen [ Time Frame: 5-50 days ] [ Designated as safety issue: No ]


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 Tigecycline	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

Eligibility


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

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911573

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site


Responsible Party:	Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:	NCT00911573 History of Changes
Other Study ID Numbers:	3074K4-3339 B1811002
Study First Received:	May 29, 2009
Last Updated:	June 5, 2012
Health Authority:	United States: Food and Drug Administration

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


pediatry children skin bacteria MRSA

Additional relevant MeSH terms:


Infection Communicable Diseases Skin Diseases Vancomycin Clindamycin Clindamycin palmitate Clindamycin phosphate	Tigecycline Minocycline Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016