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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ClinicalTrials.gov Identifier: NCT00911573 |
Recruitment Status :
Withdrawn
First Posted : June 2, 2009
Last Update Posted : June 7, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Skin Diseases Infection | Drug: Tigecycline Drug: Clindamycin (or Vancomycin if needed) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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 |
Study Start Date : | August 2011 |
Estimated Primary Completion Date : | May 2014 |
Estimated Study Completion Date : | May 2014 |

Arm | Intervention/treatment |
---|---|
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 |
- 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 ]
- 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 ]
- Clinical cure rates by baseline pathogen (including MRSA) at test-of-cure (TOC) visit [ Time Frame: 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 [ Time Frame: 15-37 days ]
- Development of decreased susceptibility [ Time Frame: 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 [ Time Frame: 15-37 days ]
- Susceptibility data by pathogen [ Time Frame: 5-50 days ]

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Ages Eligible for Study: | 8 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911573
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
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 |
First Posted: | June 2, 2009 Key Record Dates |
Last Update Posted: | June 7, 2012 |
Last Verified: | June 2012 |
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 |