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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

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Skin Diseases, Infection
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00911573
Pfizer
Withdrawn
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

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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
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
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).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Skin Diseases
  • Infection
  • 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
  • Experimental: A
    Tigecycline
    Intervention: Drug: Tigecycline
  • Active Comparator: B
    Clindamycin (or Vancomycin if needed)
    Intervention: Drug: Clindamycin (or Vancomycin if needed)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
May 2014
May 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
8 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Korea, Republic of,   Ukraine,   United States
 
NCT00911573
3074K4-3339
B1811002
Yes
Not Provided
Not Provided
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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