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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

Information source: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Skin Diseases; Infection

Intervention: Tigecycline (Drug); Clindamycin (or Vancomycin if needed) (Drug)

Phase: Phase 3

Status: Withdrawn

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Clinical response rate at the test-of-cure visit for the 2 co-primary populations: clinically evaluable and clinically modified intent to treat populations

Secondary outcome:

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

Clinical cure rates by baseline pathogen (including MRSA) at test-of-cure (TOC) visit

Clinical response and microbiological response at the subject level for subjects with monomicrobial and polymicrobial infections at test-of-cure (TOC) visit

Development of decreased susceptibility

Clinical response and microbial response at subject level by baseline pathogen and minimum inhibitory concentration (MIC) values at test-of-cure (TOC) visit

Susceptibility data by pathogen

Eligibility

Minimum age: 8 Years. Maximum age: 17 Years. Gender(s): Both.

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).

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: August 2011
Last updated: June 5, 2012

Page last updated: August 23, 2015

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