Skin Diseases, BacterialPhase 4NCT00368537
Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections
A Phase 4 study testing Tigecycline and ampicillin-sulbactam in people with Skin Diseases, Bacterial, run by Wyeth is now a wholly owned subsidiary of Pfizer at 57 sites in 12 countries.
Trial summary
The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Diseases, Bacterial
- What is being tested?
- Tigecycline and ampicillin-sulbactam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 57 sitesin 12 countries
- Study dates
- Sep 2006to Sep 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of complicated skin or skin structure infection
- Male or female, 18 years or older
- Need for intravenous treatment for 4 to 14 days
Who cannot join
- Skin infection that can be treated by surgery \& wound care alone
- Diabetic foot ulcers or bedsores where the infection is present longer than 1 week
- Poor circulation such that amputation of the infected site is likely within a month Other exclusions apply
Trial locations and contacts
57 sites in 12 countries.
57 sites in 12 countries
United States31 sites
Study site
Buffalo, New York, 14215
Study site
Cambridge, Massachusetts, 02139
Study site
Chula Vista, California, 91911
Study site
Columbus, Ohio, 43214
Study site
Decatur, Illinois, 62526
Study site
Denver, Colorado, 80218
Study site
Detroit, Michigan, 48202
Study site
Elmira, New York, 14905
Study site
Fort Gordon, Georgia, 30905
Study site
Fort Worth, Texas, 76104
Study site
Hackensack, New Jersey, 07601
Study site
Houston, Texas, 77026
Study site
Idaho Falls, Idaho, 83404
Study site
Jonesboro, Arkansas, 72401
Study site
Lansdale, Pennsylvania, 19446
Study site
Lima, Ohio, 45801
Study site
Lincoln, Nebraska, 68510
Study site
Mission Viejo, California, 92691
Study site
Naperville, Illinois, 60540
Study site
National City, California, 91950
Study site
Neptune City, New Jersey, 07754
Study site
New Hyde Park, New York, 11040
Study site
Orlando, Florida, 32803
Study site
Philadelphia, Pennsylvania, 19140
Study site
Scottsdale, Arizona, 85251
Study site
Springfield, Illinois, 62702
Study site
Topeka, Kansas, 66606
Study site
Vero Beach, Florida, 32960
Study site
Washington D.C., District of Columbia, 20017
Study site
Washington D.C., District of Columbia, 20037
Study site
Worcester, Massachusetts, 01655
Canada7 sites
Study site
Chicoutimi, Quebec, G7H 5H6
Study site
Montreal, Quebec, H1T 2M4
Study site
Québec, G1V 4G5
Study site
Saskatoon, Saskatchewan, S7N 0W8
Study site
Sherbrooke, Quebec, J1H 5N4
Study site
Trois-Rivières, Quebec, G8Z 3R9
Study site
Winnipeg, Manitoba, R3A 1R9
South Africa4 sites
Study site
Cape Town, 7531
Study site
Gauteng, 0181
Study site
KZ-Natal, 3610
Study site
Mpumalanga, 1050
South Korea4 sites
Study site
Daejeon, 301-721
Study site
Incheon, 405-760
Study site
Seoul, 120-752
Study site
Seoul, 133-791
Thailand3 sites
Study site
Bangkok, 10330
Study site
Bangkok, 10400
Study site
Bangkok, 10700
About this study
Official title: A Multicenter, Randomized, Open-Label Comparison of the Safety And Efficacy of Tigecycline With That of Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Complicated Skin And Skin Structure Infections
The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).
- Conditions
- Skin Diseases, Bacterial
- Being tested
- Tigecycline, ampicillin-sulbactam
- Keywords
- skin infection, antibiotics
- Medical subject headings
- Skin Diseases, Bacterial, Cellulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TigecyclineDrug
Treatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours)
ampicillin-sulbactamDrug
Ampicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs.
A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Arm 1: Tigecycline Receives: Drug: Tigecycline |
| 2 | Active comparator | Arm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide Receives: Drug: ampicillin-sulbactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit
Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made.
Measured: up to 6 weeks
Secondary outcomes (4)
Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit
Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. ME population were subjects who were CE and had baseline culture with at least 1 identified isolate that was susceptible to study drug and comparator. TOC performed 8-50 days after last dose of study drug.
Measured: up to 6 weeks
Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit
Microbiological response assessed at patient level. Eradication=baseline isolate not present in repeat culture from the original infection site; Presumed Eradication=clinical response of cure precluded the availability of a specimen for culture; Persistence=baseline isolate present in repeat culture from the original infection site; Presumed Persistence=culture data not available for patients with a clinical response of failure; Superinfection=culture from the primary infection site had new pathogen not identified as a baseline isolate and clinical response was failure.
Measured: up to 6 weeks
Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate
In vitro activity of the study drugs against a range of pathogenic bacteria that cause complicated skin and skin structure infection (cSSSI) were analyzed using MIC. MIC 50 and MIC 90 are the lowest concentrations of a drug that inhibit the growth of 50% and 90% of a microorganism, respectively. TOC performed 8-50 days after last dose of study drug.
Measured: up to 6 weeks
Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients
Healthcare resource utilization assessment included intensive care unit (ICU) and non-ICU inpatient hospitalization. TOC performed 8-50 days after last dose of study drug.
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2006 (estimated)
- Study startSep 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin Diseases, BacterialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of PfizerTrial Manager, Principal investigator, For Hong Kong: medinfo@wyeth.comTrial Manager, Principal investigator, For South Africa: ZAFinfo@wyeth.comTrial Manager, Principal investigator, For Taiwan: medinfo@wyeth.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00368537
- Sponsor's protocol ID
- 3074A1-900
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2006
- Last updated
- 15 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Matthews P, Alpert M, Rahav G, Rill D, Zito E, Gardiner D, Pedersen R, Babinchak T, McGovern PC; Tigecycline 900 cSSSI Study Group. A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections. BMC Infect Dis. 2012 Nov 12;12:297. doi: 10.1186/1471-2334-12-297.
PubMed 23145952
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label Comparison of the Safety And Efficacy of Tigecycline With That of Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Complicated Skin And Skin Structure Infections
- ClinicalTrials.gov ID
- NCT00368537
- Acronym / sponsor ID
- 3074A1-900
- Conditions
- Skin Diseases, Bacterial
- Keywords
- skin infection, antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Aug 2006 (estimated)
- Results
- Posted 9 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and efficacy of the antibiotic tigecycline with other antibiotics, ampicillin-sulbactam, and amoxicillin-clavulanate in the treatment of a complicated skin and/or skin structure infection (cSSSI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: TigecyclineArm 1: Tigecycline |
| 2 | Active comparator | Drug: ampicillin-sulbactamArm 2: Ampicillin-Sulbactam or Amoxicillin-Clavulanate plus or minus a glycopeptide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of complicated skin or skin structure infection
- Male or female, 18 years or older
- Need for intravenous treatment for 4 to 14 days
Key exclusion criteria (3 listed)
- Skin infection that can be treated by surgery \& wound care alone
- Diabetic foot ulcers or bedsores where the infection is present longer than 1 week
- Poor circulation such that amputation of the infected site is likely within a month Other exclusions apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TigecyclineTreatment A: Tigecycline every 12 hours intravenous (IV) (an initial dose of 100 mg followed by 50 mg every 12 hours) | Drug | 1 |
| ampicillin-sulbactamAmpicillin-sulbactam: 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (3 g ampicillin plus 1 g sulbactam) intravenous (IV) every 6 hrs or Amoxicillin-clavulanate: 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hrs. A glycopeptide antibiotic (either vancomycin 1 g IV every 12 hrs or teicoplanin IV loading dose of 400 mg the first day followed by a maintenance dose of 200 mg daily) may be added to the aminopenicillin/betalactamase inhibitor regimen if infection with methicillin-resistant staphylococcus aureus (MRSA) is suspected or confirmed within the first 72 hrs of enrollment. If culture results fail to show a resistant organism, use of the glycopeptide may be discontinued. | Drug | 2 |
Primary outcome
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit
Time frame: up to 6 weeks
Investigator assigned clinical response of cure of the cSSSI defined as: resolution of all clinical signs and symptoms of infection (healing of chronic underlying skin ulcer not required) or improvement of signs or symptoms of the infection to such an extent that no further antibacterial therapy was necessary. CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made.
4 secondary outcomes
Number of Microbiologically Evaluable Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit
Time frame: up to 6 weeks
Number of Microbiologically Evaluable Patients by Microbiologic Response at Test-of-Cure (TOC) Visit
Time frame: up to 6 weeks
Minimum Inhibitory Concentration (MIC) 50 and 90 by Baseline Isolate
Time frame: up to 6 weeks
Inpatient Healthcare Resource Utilization on or Before Test-of-Cure - Number of Patients
Time frame: up to 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23145952Matthews P, Alpert M, Rahav G, Rill D, Zito E, Gardiner D, Pedersen R, Babinchak T, McGovern PC; Tigecycline 900 cSSSI Study Group. A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections. BMC Infect Dis. 2012 Nov 12;12:297. doi: 10.1186/1471-2334-12-297.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager principal investigator
For Hong Kong: medinfo@wyeth.com
Trial Manager principal investigator
For South Africa: ZAFinfo@wyeth.com
57 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tigecycline and ampicillin-sulbactam in people with Skin Diseases, Bacterial, run by Wyeth is now a wholly owned subsidiary of Pfizer at 57 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in United States, Canada, South Africa, South Korea, Thailand and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-cure (TOC) Visit (time frame: up to 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00368537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.