NCT00911573

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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2011

Typical duration for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2009

Completed
2.2 years until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

June 7, 2012

Status Verified

June 1, 2012

Enrollment Period

2.8 years

First QC Date

May 29, 2009

Last Update Submit

June 5, 2012

Conditions

Skin DiseasesInfection

Keywords

pediatrychildrenskinbacteriaMRSA

Outcome Measures

Primary Outcomes (1)

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

    15-37 days

Secondary Outcomes (6)

  • 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

    5-49 days

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

    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

    15-37 days

  • Development of decreased susceptibility

    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

    15-37 days

  • +1 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL

Tigecycline

Drug: Tigecycline

B

ACTIVE COMPARATOR

Clindamycin (or Vancomycin if needed)

Drug: Clindamycin (or Vancomycin if needed)

Interventions

TigecyclineDRUG

50 mg IV every 12 hours up to 14 days

Also known as: Tygacil
A
Clindamycin (or Vancomycin if needed)DRUG

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

B

Eligibility Criteria

Age8 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Skin DiseasesInfections

Interventions

TigecyclineClindamycin

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsLincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 2, 2009

Study Start

August 1, 2011

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

June 7, 2012

Record last verified: 2012-06