Community-Acquired Bacterial Pneumonia, Complicated Intra-abdominal Infections, Complicated Skin and Skin Structure Infections
Conditions
Keywords
infection, Tygacil, PMS
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.
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.
Interventions
DRUGtigecycline
As prescribed by physician in usual clinical practice
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment | 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 | 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) | 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. |
Countries
South Korea
Participant flow
Recruitment details
Participants were enrolled between May 2010 and April 2015 from Korean health care centers.
Participants by arm
| Arm | Count |
|---|---|
| Tygacil Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. | 3,169 |
| Total | 3,169 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 2 |
| Overall Study | Treated prior to the Site Initiation | 1 |
Baseline characteristics
| Characteristic | Tygacil |
|---|---|
| Age, Customized 30 to 39 years | 200 Participants |
| Age, Customized <30 years | 126 Participants |
| Age, Customized 40 to 49 years | 346 Participants |
| Age, Customized 50 to 64 years | 1116 Participants |
| Age, Customized >=65 years | 1381 Participants |
| Infection Site CAP | 242 Participants |
| Infection Site cIAI | 1947 Participants |
| Infection Site cIAI + CAP | 2 Participants |
| Infection Site cIAI + cSSSI | 2 Participants |
| Infection Site cSSSI | 976 Participants |
| Severity of Infection Mild | 287 Participants |
| Severity of Infection Moderate | 2072 Participants |
| Severity of Infection Severe | 810 Participants |
| Sex: Female, Male Female | 1089 Participants |
| Sex: Female, Male Male | 2080 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 537 / 3,169 |
| serious Total, serious adverse events | 419 / 3,169 |
Outcome results
Primary
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.
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.
Population: Safety Analysis Set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tygacil | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs | Unexpected ADRs | 0.44 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs | AEs | 32.98 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs | ADRs | 9.85 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs | SAEs | 13.22 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs | SADRs | 0.13 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events (AEs)/Adverse Drug Reactions (ADRs), Serious AEs (SAEs)/Serious ADRs (SADRs), and Unexpected AEs/ADRs | Unexpected AEs | 8.24 Percentage of Participants |
Primary
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.
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.
Population: Safety Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Geriatric: >=65 Years | 35.55 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Age: <30 Years | 30.16 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Sex: Male | 32.55 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | General Medical History (Present): Yes | 35.03 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | General Medical History (Present): No | 9.45 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Total Treatment Period of Tygacil: <7 Days | 34.74 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Total Treatment Period of Tygacil: 7 to 14 Days | 29.94 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Total Treatment Period of Tygacil: >14 Days | 34.99 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Mean Daily Dose of Tygacil: <50 mg | 100.00 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Mean Daily Dose of Tygacil: 50 to <100 mg | 39.92 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Mean Daily Dose of Tygacil: 100 to <200 mg | 30.57 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Mean Daily Dose of Tygacil: >=200 mg | 60.00 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Past Medication and Therapy: Yes | 33.48 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Past Medication and Therapy: No | 27.02 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Concomitant Medications: Yes | 33.77 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Prospectively Collected Data | 34.15 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Retrospectively Collected Data | 32.62 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Geriatric: <65 Years | 30.98 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Age: 40 to 49 Yeas | 27.46 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Age: 50 to 64 Years | 31.99 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Age: >=65 Years | 35.55 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Sex: Female | 33.79 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Duration of Disease: <3 Months | 32.88 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Duration of Disease: >=3 Months and <6 Months | 33.63 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Duration of Disease: >=6 Months | 32.20 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Infection Site: cSSSI | 28.79 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Infection Site: cIAI | 34.87 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Infection Site: CAP | 34.30 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Infection Site: cIAI + cSSSI | 50.00 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Infection Site: cIAI + CAP | 50.00 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Severity of Infection: Mild | 26.83 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Severity of Infection: Moderate | 27.27 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Severity of Infection: Severe | 49.75 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | General Medical History: Yes | 34.91 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | General Medical History: No | 6.48 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | General Medical History (Past): Yes | 37.10 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | General Medical History (Past): No | 31.00 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Kidney Disorder: Yes | 46.86 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Kidney Disorder: No | 29.69 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Liver Disorder: Yes | 39.82 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Liver Disorder: No | 30.20 Percentage of Participants |
| Tygacil | Percentage of Participants With Adverse Events by Baseline and Treatment Characteristics | Concomitant Medications: No | 14.06 Percentage of Participants |
Comparison: Geriatrc: \<65 Years Versus (VS) Geriatrc: \>=65 Yearsp-value: 0.0067Chi-squared
Comparison: Comparison among Age categories: \<30 Years, 30 to 39 Years, 40 to 49 Years, 50 to 64 Years, and \>=65 Years.p-value: 0.0412Chi-squared
Comparison: Sex: Male VS Sex: Femalep-value: 0.4792Chi-squared
Comparison: Comparson among Duration of Disease categories: \<3 Months, \>=3 Months and \<6 Months, and \>=6 Monthsp-value: 0.9669Chi-squared
Comparison: Comparison among subgroups of infection site: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.p-value: 0.0064Fisher Exact
Comparison: Comparison among severity of infection subgroups: Mild, Moderate, and Severe.p-value: <0.0001Chi-squared
Comparison: General Medical History: Yes VS General Medical History: Nop-value: <0.0001Chi-squared
Comparison: General Medical History (Present): Yes VS General Medical History (Present): Nop-value: <0.0001Chi-squared
Comparison: General Medical History (Past): Yes VS General Medical History (Past): Nop-value: 0.0006Chi-squared
Comparison: Kidney Disorder: Yes VS Kidney Disorder: Nop-value: <0.0001Chi-squared
Comparison: Liver Disorder: Yes VS Liver Disorder: Nop-value: <0.0001Chi-squared
Comparison: Comparison among subgroups of Total Treatment Period of Tygacil: \<7 Days, 7 to 14 Days, and \>14 Daysp-value: 0.0153Chi-squared
Comparison: Comparison among subgroups of Mean Daily Dose of Tygacil: \<50 mg, 50 to \<100 mg, 100 to \<200 mg, and \>=200 mg.p-value: <0.0001Fisher Exact
Comparison: Past Medication and Therapy: Yes VS Past Medication and Therapy: Nop-value: 0.0376Chi-squared
Comparison: Concomitant Medications: Yes VS Concomitant Medications: Nop-value: <0.0001Chi-squared
Secondary
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.
Time frame: At the TOC or EOT assessment
Population: Effectiveness Analysis Set from the prospective study phase; n refers to the total nunber of participants who had evaluable data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tygacil | Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) | Eradication (Documented or Presumed) (n=514) | 46.69 Percentage of Participants |
| Tygacil | Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) | Unevaluable (n=514) | 20.62 Percentage of Participants |
| Tygacil | Percentage of Participants by Microbiologic Response at the Participant Level (Prospective Study Phase) | Persistence (Documented or Presumed) (n=514) | 32.68 Percentage of Participants |
Secondary
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 .
Time frame: At the TOC or EOT assessment
Population: Effectiveness Analysis Set: Participants who received at least one dose of Tygacil and had related effectiveness endpoints evaluated at least.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tygacil | Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment | Total | 71.59 Percentage of Participants |
| Tygacil | Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment | Prospectively Collected Data | 59.68 Percentage of Participants |
| Tygacil | Percentage of Participants With Clinical Response of Cure or Improvement at the Test-of-Cure(TOC) or End-of-Treatment (EOT) Assessment | Retrospectively Collected Data | 74.97 Percentage of Participants |
Secondary
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 .
Time frame: At the TOC or EOT assessment
Population: Effectiveness Analysis Set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tygacil | Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site | Infection Site: cSSSI | 77.53 Percentage of Participants |
| Tygacil | Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site | Infection Site: cIAI | 71.52 Percentage of Participants |
| Tygacil | Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site | Infection Site: CAP | 45.35 Percentage of Participants |
| Tygacil | Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site | Infection Site: cIAI + cSSSI | 0.00 Percentage of Participants |
| Tygacil | Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site | Infection Site: cIAI + CAP | 50.00 Percentage of Participants |
| Tygacil | Percentage of Participants With Clinical Response of Cure or Improvement at the TOC or EOT Assessment by Infection Site | Infection Site: Total | 71.59 Percentage of Participants |
Comparison: Comparison among subgroups of Infection Sites: cSSSI, cIAI, CAP, cIAI + cSSSI, and cIAI + CAP.p-value: <0.0001Fisher Exact