Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment
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| ClinicalTrials.gov Identifier: NCT01072539 |
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Recruitment Status :
Completed
First Posted : February 22, 2010
Results First Posted : May 30, 2016
Last Update Posted : May 30, 2016
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
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Brief 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 response at the subject level, if available.
| Condition or disease | Intervention/treatment |
|---|---|
| Complicated Skin and Skin Structure Infections Complicated Intra-abdominal Infections Community-Acquired Bacterial Pneumonia | Drug: tigecycline |
| Study Type : | Observational |
| Actual Enrollment : | 3172 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | A Post-marketing Surveillance (Pms) Study Of Safety And Effectiveness In Patients With Tigecycline Treatment |
| Study Start Date : | May 2010 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | April 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Tigecycline
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients who have approved indications of Tygacil
Approved indications of Tygacil -complicated intraabdominal infection, complicated skin and skin structure infection, community-acquired bacterial pneumonia |
Drug: tigecycline
As prescribed by physician in usual clinical practice
Other Name: Tygacil |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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 ]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 .
- 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 ]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 .
- Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) [ Time Frame: At the TOC or EOT assessment ]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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
General Hospitals
Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Information from the National Library of Medicine
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): NCT01072539
Locations
Show 36 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01072539 |
| Other Study ID Numbers: |
3074X1-4527 B1811040 ( Other Identifier: Alias Study Number ) |
| First Posted: | February 22, 2010 Key Record Dates |
| Results First Posted: | May 30, 2016 |
| Last Update Posted: | May 30, 2016 |
| Last Verified: | April 2016 |
Keywords provided by Pfizer:
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infection Tygacil PMS |
Additional relevant MeSH terms:
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Infections Communicable Diseases Intraabdominal Infections Pneumonia, Bacterial Disease Attributes Pathologic Processes Pneumonia Respiratory Tract Infections Lung Diseases |
Respiratory Tract Diseases Bacterial Infections Bacterial Infections and Mycoses Tigecycline Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |