Complicated Skin and Skin Structure InfectionsNCT01072539
Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
An observational study of Complicated Skin and Skin Structure Infections and Complicated Intra-abdominal Infections, run by Pfizer at 36 sites in South Korea.
Trial summary
The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections, Community-Acquired Bacterial Pneumonia
- What is being tested?
- tigecycline
- How many people
- 3,172 participants
- Where
- 36 sitesSouth Korea
- Study dates
- May 2010to Apr 2015
- Phase
- Observational
- 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
Study population: General Hospitals
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
- Adults 18 years of age or older, who have one of the followings:
- Complicated skin and skin structure infections
- Complicated intra-abdominal infections
- Community-acquired bacterial pneumonia
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- Patients who have known hypersensitivity to tigecycline
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
South Korea36 sites
Kosin University Gospel Hospital
Busan, 602-702
Dong-A University Medical Center (Dong-A University Hospital)
Busan, 602-715
Cheongju St. Mary's Hospital
Cheongju-si, 363-568
Keimyung University Dongsan Medical Center (KUDMC)
Daegu, 700-712
Kyungpook National University Hospital (KNUH)
Daegu, 700-721
Daegu fatima hospital
Daegu, 701-724
Yeungnam University Medical Center
Daegu, 705-717
Daegu Catholic University Medical Center (DCUMC)
Daegu, 705-718
Hanil Medical Center
Dobong-Gu, Seoul, 132-033
Korea University Ansan Hospital
Gyeonggi-do, 425-707
Ajou University Hospital
Gyeonggi-do, 443-721
Wonkwang University Hospital
Iksan-si, Jeollabuk-do, 573-250
Inha University Hospital
Incheon, 400-711
Gachon University Gil Hospital
Incheon, 405-760
Jeju National University Hospital
Jeju City, 690-767
Chonbuk National University Hospital
Jeonju, Jeollabuk-do, 561-712
Yonsei University Wonju College of Medicine- Wonju Christian Hospital
Kangwon-do, 220-701
Gachon University Gil Hospital
Namdong-gu, Incheon, 405-760
Korea University Anam Hospital
Seoul, 02841
Yonsei University College of Medicine Severance Hospital Rheumatology Internal Medicine
Seoul, 120752
Kyunghee University Medical Hospital
Seoul, 130-702
Hallym University Kangdong Sacred Heart Hospital
Seoul, 134-701
Kyung Hee University Hospital at Gangdong
Seoul, 134-727
Kangdong Sacred Heart Hospital
Seoul, 134-814
Samsung Medical Center
Seoul, 135-710
Korea University Anam Hospital
Seoul, 136-705
Asan Medical Center, University of Ulsan
Seoul, 138-736
Asan Medical Center
Seoul, 138-736
Eulji Medical Center
Seoul, 139-711
Hallym University Kangnam Sacred Heart Hospital
Seoul, 150-950
Hallym University Medical Center (HUMC) - Kangnam Sacred Heart Hospital
Seoul, 150-950
Korea University Guro Hospital
Seoul, 152-703
Kangbuk Samsung Medical Center
Seoul
Ajou University Hospital
Suwon, Gyeonggi-do, 443-380
Ulsan University Hospital
Ulsan, 682-714
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 626-770
About this study
Official title: A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment
The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available.
Read the detailed description
Prior to the conduct of this study, the investigator will explain the study objective, etc to prospective subjects on the basis of "explanatory material." The informed consent will be obtained in written form by each subject voluntarily.
- Conditions
- Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections, Community-Acquired Bacterial Pneumonia
- Being tested
- tigecycline
- Keywords
- infection, Tygacil, PMS
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tigecyclineDrug
Also called Tygacil
As prescribed by physician in usual clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Patients who have approved indications of Tygacil | Approved indications of Tygacil
-complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia Receives: Drug: tigecycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs
All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer.
Measured: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics
Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.
Measured: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.
Secondary outcomes (3)
Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment
Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil .
Measured: At the TOC or EOT assessment
Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site
Participants whose clinical response was assessed as cure or improvement at the TOC or EOT assessment were considered as "effective" to the treatment of Tygacil .
Measured: At the TOC or EOT assessment
Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)
Definitions: Eradication: None of the baseline isolates were present in a repeat culture taken from the original site of infection (documented) or a clinical response of cure precluded the availability of a specimen for culture (presumed). Persistence: Any baseline isolates were present in a repeat culture obtained from the original site of infection (documented) or culture data were not available for a participant with a clinical response of failure (presumed). Unevaluable: participants who died during therapy for non-infection-related reasons, died for any reason within 2 days after first administration of Tygacil, were lost to follow-up (ie, clinical response was not able to be assessed), or had no baseline isolates.
Measured: At the TOC or EOT assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2015
- Study completionApr 2015
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.
- Other trials for Complicated Skin and Skin Structure InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072539
- Sponsor's protocol ID
- 3074X1-4527
- Other IDs
- B1811040
- Status last verified
- Dec 2023
- First submitted
- 17 Feb 2010
- Last updated
- 29 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment
- ClinicalTrials.gov ID
- NCT01072539
- Acronym / sponsor ID
- 3074X1-4527
- Conditions
- Complicated Skin and Skin Structure Infections, Complicated Intra-abdominal Infections, Community-Acquired Bacterial Pneumonia
- Keywords
- infection, Tygacil, PMS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,172 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 Feb 2010 (estimated)
- Results
- Posted 30 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to identify any changes on the safety profile of adverse events and serious adverse events. And the secondary objective is to evaluate clinical response in the clinically evaluable population at test-of cure (TOC) or at the end of treatment (EOT) assessment, and microbiologic response at the subject level, if available.
Detailed description
Prior to the conduct of this study, the investigator will explain the study objective, etc to prospective subjects on the basis of "explanatory material." The informed consent will be obtained in written form by each subject voluntarily.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who have approved indications of Tygacil | – | Drug: tigecyclineApproved indications of Tygacil -complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- General Hospitals
Key inclusion criteria (5 listed)
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study. Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study :
- Complicated skin and skin structure infections
- Complicated intra-abdominal infections
- Community-acquired bacterial pneumonia
Key exclusion criteria (3 listed)
- Patients who have known hypersensitivity to tigecycline
- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
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 |
|---|---|---|
| tigecyclineAlso: TygacilAs prescribed by physician in usual clinical practice | Drug | Patients who have approved indications of Tygacil |
Primary outcome
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs
Time frame: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.
All AEs reported after start of administration of Tygacil were considered as on treatment and summarized. All AEs, except for those with causal relationship to the study drug assessed as "unlikely", were considered as ADRs. Unexpected AEs/ADRs were classified by medical review with reference to the approved local product document and confirmed by Pfizer.
Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics
Time frame: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.
Baseline and treatment characteristics included: prospectively/retrospectively collected data, geriatric status (<65 years or >=65 years), age categories, sex, duration of disease, infection site, severity of infection, general, present and past medical history, kidney disorder, liver disorder, total administration period of Tygacil, mean daily dose of Tygacil, past medication and therapy, and concomitant medications.
3 secondary outcomes
Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment
Time frame: At the TOC or EOT assessment
Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site
Time frame: At the TOC or EOT assessment
Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase)
Time frame: At the TOC or EOT assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Complicated Skin and Skin Structure Infections
RecruitingObservational study
Complicated Infections in Otorhinolaryngology
Sinusitis, Otitis
Active, not recruitingObservational study
Comparative Analysis of Nemonoxacin and Other Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA) Antimicrobial Therapy in Patients With Complicated Skin and Soft Tissue Infections (cSSTI): a Retrospective Chart Review Study
Methicillin-susceptible S. Aureus (MSSA), Anti-methicillin Resistant Staphylococcus Aureus (Anti-MRSA)
Not yet recruitingPhase 3
Antimicrobial Adjuvants to Revert the Imbalance of Skin Microbiota for Improved Outcomes of Complicated Cutaneous Leishmaniasis Treatment in Ethiopia
Leishmaniasis, Cutaneous
Not yet recruitingObservational study
Peri-appendiceal Abscess and Phlegmon in Acute Complicated Appendicitis Patients
Acute Complicated Appendicitis With Peri-appendiceal Abscess or Phlegmon
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.
Pfizer CT.gov Call Center study director
Pfizer
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Skin and Skin Structure Infections and Complicated Intra-abdominal Infections, run by Pfizer at 36 sites in South Korea.
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 5 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 29 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in South Korea. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 May 2016). 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?
Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs (time frame: From the time of the participant's first dosing in the observational period as per study design through and including 28 calendar days after the last administration of the study drug within the observational period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2023.