Study Evaluating Tigecycline Versus Clindamycin on Complicated Skin and Skin Structure Infections Including Those Due to Methicillin-resistant Staphylococcus Aureus (MRSA) - Full Text View

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00911573

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 Infectious	Drug: Tigecycline Drug: Clindamycin (or Vancomycin if needed)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Tigecycline vs Clindamycin for the Treatment of Complicated Skin and Skin Structure Infections, Including Those Due to MRSA, in Pediatric Subject 8-17 Years

Resource links provided by NLM:

MedlinePlus related topics: Skin Conditions

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

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Infection clearance: subject & pathogen response. Pharmacokinetic/pharmacodynamic. Susceptibility for a range of pathogens [ Time Frame: 34-50 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	June 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Tigecycline	Drug: Tigecycline
B: Active Comparator Clindamycin (or Vancomycin if needed)	Drug: Clindamycin (or Vancomycin if needed)

Eligibility

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

Criteria

Inclusion Criteria (non exhaustive list):

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.
cSSSI criteria related to sign of systemic infection, signs and symptoms.

Exclusion Criteria (non exhaustive list):

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

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

Locations

United States, Ohio

Akron, Ohio, United States, 44308
United States, Virginia

Richmond, Virginia, United States, 23298
Korea, Republic of

Seoul, Korea, Republic of, 138-736

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3074K4-3339
Study First Received:	May 29, 2009
Last Updated:	December 10, 2009
ClinicalTrials.gov Identifier:	NCT00911573 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

pediatry
children
skin
bacteria
MRSA

Additional relevant MeSH terms:

Communicable Diseases
Anti-Infective Agents
Clindamycin
Skin Diseases
Clindamycin-2-phosphate
Molecular Mechanisms of Pharmacological Action
Tigecycline

Enzyme Inhibitors
Infection
Pharmacologic Actions
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Therapeutic Uses
Vancomycin

ClinicalTrials.gov processed this record on February 08, 2010