Infection
Conditions
Brief summary
To assess the efficacy and safety of Tygacil in the usual German hospital setting. The main goals are: to assess the efficacy of Tygacil under usual care conditions (cure rate); to assess the main side effects observed in daily medical practice (Safety of Tygacil); to determine whether patients are optimally dosed with Tygacil (according to the label) and the proportion of patients receiving a monotherapy versus combination therapy; to observe the potential resistance development against Tygacil in Germany; to determine which antibiotic agents are chosen for a combination therapy with Tygacil; to determine to which antibiotic substance non-responders to Tygacil are switched; to assess the duration of the intravenous therapy with Tygacil and to determine whether and which patients receive an oral antibiotic substance after the therapy with Tygacil; to collect information on profile, comorbidities and characteristics of patients treated with Tygacil.
Detailed description
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician.
Interventions
DRUGtigecycline
The patients will be treated in accordance with the requirements of the labeling of tigecycline in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Actual or planned therapy with tigecycline. * At least 18 years old.
Exclusion criteria
* Hypersensitivity to antibiotics or tigecycline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical and Microbiological Cure: All Participants | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. |
| Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. |
| Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections | End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) | Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure. |
| Percentage of Participants With Composite Cure: All Participants | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. |
| Percentage of Participants With Composite Cure: Nosocomial Infections | End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days) | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. |
| Percentage of Participants With Composite Cure: Community-acquired Infections | End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days) | Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Probable Failure at Follow-up | Follow-up (up to Day 47) | Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy. |
| Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Follow-up (up to Day 47) | Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy. |
| Antibiotic Agents Chosen for Combination Therapy With Tigecycline | Baseline to End of Treatment (up to Day 47) | Percentage of participants who received each antibiotic administered as combination therapy with tigecycline. |
| Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic | Baseline to End of Treatment (up to Day 47) | Reasons for change in antibiotic treatment from Tygacil to another antibiotic. |
| Reasons for Utilization of Tygacil | Baseline to End of Treatment (up to Day 47) | — |
| Overall Mortality: All Participants | Baseline to End of Treatment (up to Day 47) | Deaths for any reasons occurring during the study observation period. |
Participant flow
Recruitment details
Non-interventional study; participants were selected and treated according to the usual clinical practice of their physician.
Pre-assignment details
A total of 1,028 participants were documented at 137 observational sites. Three participants were excluded from analysis due to retrospective documentation.
Participants by arm
| Arm | Count |
|---|---|
| Tygacil Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day | 1,025 |
| Total | 1,025 |
Baseline characteristics
| Characteristic | Tygacil |
|---|---|
| Age Continuous | 64.4 years STANDARD_DEVIATION 13.7 |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Acinetobacter spp. (n=4) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Bacteroides fragilis (n=3) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Bacteroides thetaiotamicron (n=1) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Citrobacter freundii (n=5) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Clostridium perfringens (n=1) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Enterobacter species (spp) (n=26) | 3.8 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Enterococcus faecalis (n=65) | 1.5 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Enterococcus faecium (n=146) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Escherichia coli (n=99) | 1.0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Haemophilus spp (n=2) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Klebsiella oxytoca (n=16) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Klebsiella pneumoniae (n=29) | 3.4 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Morganella morganii (n=1) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Other Bacteroides species (n=5) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Other clostridiae (n=6) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Other pathogens (unspecified) (n=30) | 13.3 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Peptostreptococcus (n=2) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Proteus mirabilis (n=6) | 16.7 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Proteus vulgaris (n=3) | 33.3 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Pseudomonas aeruginosa (n=23) | 73.9 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Serratia spp (n=1) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Staphylococcus aureus (n=120) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Staphylococcus spp (n=63) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Stenotrophomonas maltophilia (n=8) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Streptococcus agalactiae (B group) (n=1) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Streptococcus anginosus group (n=5) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Streptococcus pneumoniae (n=2) | 0 percentage of participants |
| Resistance Patterns at Baseline: Percentage of Participants with Resistant Pathogens Streptococcus pyogenes (A group) (n=7) | 0 percentage of participants |
| Sex/Gender, Customized Female | 380 participants |
| Sex/Gender, Customized Male | 642 participants |
| Sex/Gender, Customized Missing Data (Unspecified) | 3 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 155 / 1,025 |
| serious Total, serious adverse events | 245 / 1,025 |
Outcome results
Primary
Percentage of Participants With Clinical and Microbiological Cure: All Participants
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
Time frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Population: All participants: participants exposed to Tygacil who had non-retrospective post-baseline data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil | Percentage of Participants With Clinical and Microbiological Cure: All Participants | 33.8 percentage of participants |
Primary
Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
Time frame: End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)
Population: All participants; N = number of participants with community-acquired infections.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil | Percentage of Participants With Clinical and Microbiological Cure: Community-acquired Infections | 43.9 percentage of participants |
Primary
Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections
Cure = complete resolution of infection symptoms; no further antibiotic treatment required. A second microbiological examination was documented only for participants with treatment failure.
Time frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Population: All participants; N = number of participants with nosocomial infections.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil | Percentage of Participants With Clinical and Microbiological Cure: Nosocomial Infections | 29.0 percentage of participants |
Primary
Percentage of Participants With Composite Cure: All Participants
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
Time frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Population: All participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil | Percentage of Participants With Composite Cure: All Participants | 74.2 percentage of participants |
Primary
Percentage of Participants With Composite Cure: Community-acquired Infections
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
Time frame: End of Treatment (duration based on severity, location, and clinical response: maximum duration 47 days)
Population: All participants; N = number participants with community-acquired infections.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil | Percentage of Participants With Composite Cure: Community-acquired Infections | 82.3 percentage of participants |
Primary
Percentage of Participants With Composite Cure: Nosocomial Infections
Composite Cure = complete resolution or improvement of infection symptoms; no further antibiotic treatment required.
Time frame: End of Treatment (duration based on severity, location, and clinical response; maximum duration 47 days)
Population: All participants; N = number of participants with nosocomial infections.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil | Percentage of Participants With Composite Cure: Nosocomial Infections | 70.5 percentage of participants |
Secondary
Antibiotic Agents Chosen for Combination Therapy With Tigecycline
Percentage of participants who received each antibiotic administered as combination therapy with tigecycline.
Time frame: Baseline to End of Treatment (up to Day 47)
Population: All participants; N = number of participants who were concomitantly treated with other antibiotics in combination with Tygacil; n = number of participants who were concomitantly treated with specified antibiotic in combination with Tygacil.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | metronidazole (n=48) | 4.7 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | vancomycin (n=27) | 2.6 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | cefepime (n=26) | 2.5 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | pip/tazo (n=18) | 1.8 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | piperacillin (n=14) | 1.4 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | caspofungin (n=13) | 1.3 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | levofloxacin (n=13) | 1.3 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | tobramycin (n=10) | 1.0 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | clarithromycin (n=9) | 0.9 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | moxifloxacin (n=9) | 0.9 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | beta-lactam antibacterials, penicillins (n=2) | 0.2 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | ceftriaxone (n=2) | 0.2 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | colistin (n=2) | 0.2 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | ceftazidime (n=191) | 18.6 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | ciprofloxacin (n=62) | 6.0 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | fluconazole (n=59) | 5.8 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | meropenem (n=49) | 4.8 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | other antimycotics for system use (n=13) | 1.3 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | imipenem (n=12) | 1.2 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | primaxin (n=12) | 1.2 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | voriconazole (n=11) | 1.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | erythromycin (n=10) | 1.0 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | gentamicin (n=10) | 1.0 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | sulbactam (n=10) | 1.0 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | aciclovir (n=7) | 0.7 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | clindamycin (n=7) | 0.7 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | other beta-lactam antibacterials (n=5) | 0.5 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | ampicillin (n=4) | 0.4 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | fosfomycin (n=4) | 0.4 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | linezolid (n=4) | 0.4 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | amikacin (n=3) | 0.3 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | amphotericin B (n=3) | 0.3 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | bactrim (n=3) | 0.3 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | flucloxacillin (n=3) | 0.3 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | rifampicin (n=3) | 0.3 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | unacid (n=3) | 0.3 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | benzylpenicillin (n=2) | 0.2 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | doxycycline (n=2) | 0.2 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | ganciclovir (n=2) | 0.2 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | tazobactam (n=2) | 0.2 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | amoxi-clavulanico (n=1) | 0.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | antibiotics (n=1) | 0.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | azithromycin (n=1) | 0.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | cefotaxime (n=1) | 0.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | cefuroxime (n=1) | 0.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | chloramphenicol (n=1) | 0.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | clemizole penicillin (n=1) | 0.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | penicillin not otherwise specified (n=1) | 0.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | piperacillin with tazobactam (n=1) | 0.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | teicoplanin (n=1) | 0.1 percentage of participants |
| Tygacil | Antibiotic Agents Chosen for Combination Therapy With Tigecycline | tienam (n=1) | 0.1 percentage of participants |
Secondary
Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic
Reasons for change in antibiotic treatment from Tygacil to another antibiotic.
Time frame: Baseline to End of Treatment (up to Day 47)
Population: All participants; N = number of participants with a documented therapy switch in antibiotic treatment from Tygacil to another antibiotic; n = number of participants with specified reason for switch in antibiotic treatment . Multiple specifications were possible.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tygacil | Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic | Oral treatment continuation (n=14) | 1.4 percentage of participants |
| Tygacil | Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic | Intolerability (n=5) | 0.5 percentage of participants |
| Tygacil | Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic | Other (de-escalation) (n=80) | 7.8 percentage of participants |
| Tygacil | Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic | No clinical response (n=71) | 6.9 percentage of participants |
| Tygacil | Change of Antibiotic Treatment From Tygacil to Alternative Antibiotic | Microbiological resistance (n=26) | 2.5 percentage of participants |
Secondary
Overall Mortality: All Participants
Deaths for any reasons occurring during the study observation period.
Time frame: Baseline to End of Treatment (up to Day 47)
Population: All participants. Overall mortality was not calculated separately for nosocomial and community-acquired infections.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil | Overall Mortality: All Participants | 20.0 percentage of participants |
Secondary
Participants With Probable Failure at Follow-up
Participants with antibiogram follow-up due to treatment failure who had detectable pathogens. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.
Time frame: Follow-up (up to Day 47)
Population: All participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tygacil | Participants With Probable Failure at Follow-up | 162 participants |
Secondary
Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure
Percentage of participants with resistant pathogens for each pathogen identified at second (follow-up) microbial examination. A second microbiological examination was documented only for participants with treatment failure. Treatment failure = no significant improvement of infection symptoms under Tygacil therapy.
Time frame: Follow-up (up to Day 47)
Population: All participants; N = number of participants who had a follow-up microbial investigation due to treatment failure; n = number of participants who tested positive for pathogen and had isolates tested for pathogen resistance.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Proteus mirabilis (n=6) | 50.0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Proteus vulgaris (n=2) | 50.0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Stenotrophomonas maltophilia (n=4) | 25.0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Enterococcus faecium (n=15) | 0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Staphylococcus spp (n=5) | 0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Serratia spp (n=2) | 0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Citrobacter freundii (n=1) | 0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Acinetobacter spp. (n=1) | 0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Pseudomonas aeruginosa (n=12) | 100.0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Other pathogens (unspecified) (n=6) | 100.0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Klebsiella oxytoca (n=1) | 100.0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Klebsiella pneumoniae (n=9) | 22.2 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Enterococcus faecalis (n=10) | 20.0 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Enterobacter species (spp) (n=11) | 18.2 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Escherichia coli (n=14) | 7.1 percentage of participants |
| Tygacil | Percentage of Participants With Resistant Pathogens Identified at Follow-up Due to Treatment Failure | Staphylococcus aureus (n=16) | 6.3 percentage of participants |
Secondary
Reasons for Utilization of Tygacil
Time frame: Baseline to End of Treatment (up to Day 47)
Population: All participants; n = number of participants with specified reason for utilization of Tygacil.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Tygacil | Reasons for Utilization of Tygacil | Failure on previous antibiotic treatment (n=549) | 53.6 percentage of participants |
| Tygacil | Reasons for Utilization of Tygacil | Suspicion of resistant pathogens (n=470) | 45.9 percentage of participants |
| Tygacil | Reasons for Utilization of Tygacil | Broad efficacy spectrum (n=463) | 45.2 percentage of participants |
| Tygacil | Reasons for Utilization of Tygacil | Primary (n=114) | 11.1 percentage of participants |
| Tygacil | Reasons for Utilization of Tygacil | Intolerability to previous antibiotic (n=21) | 2.0 percentage of participants |