Gram-Positive Bacterial Infections
Conditions
Keywords
non-interventional, non-comparative, open-label study, safety, Linezolid, gram positive infections, Filipino
Brief summary
The purpose of this study is to determine if Linezolid is safe for adult Filipino patients diagnosed with gram positive infections.
Detailed description
The subjects were identified after the physician decided to prescribed the drug to the subject.
Interventions
DRUGLinezolid
1. Vancomycin-resistant, E. faecium, including concurrent bacteremia: Linezolid for 600mg (IV or oral) every 12 hours for 14-28 days 2. Nosocomial infection, cSSTI: Linezolid for 600mg (IV or oral) every 12 hours for 10-14 days 3. Uncomplicated SSTI: Linezolid for 400mg oral every 12 hours for 10-14 days
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
* Has clinical diagnosis of of the following, including cases with concurrent bacteremia, when suspected or known to be caused by susceptible strains of anaerobic or aerobic gram positive microorganisms - nosocomial pneumonia, community acquired pneumonia, complicated skin and skin structure infections, uncomplicated skin and skin structure infection, and vancomycin-resistant E. faecium * Male or female, 18 years old and above
Exclusion criteria
* Known hypersensitivity * Subjects diagnosed with pure gram-negative infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Baseline up to End of Treatment (EOT) (Day 10 up to 28) | Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Response | EOT (Day 10 up to 28) | Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Linezolid Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator's discretion. | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Death | 8 |
| Overall Study | Other | 3 |
Baseline characteristics
| Characteristic | Linezolid |
|---|---|
| Age Continuous | 59.7 years STANDARD_DEVIATION 18.2 |
| Sex: Female, Male Female | 35 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 99 |
| serious Total, serious adverse events | 10 / 99 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
Any untoward medical occurrence in a participant who received study treatment was considered an AE without regard to possibility of causal relationship.
Time frame: Baseline up to End of Treatment (EOT) (Day 10 up to 28)
Population: Safety analysis set included all the participants who received at least 1 dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Linezolid | Number of Participants With Adverse Events (AEs) | 15 participants |
Secondary
Number of Participants With Clinical Response
Clinical response assessed by Investigator at EOT visit as Cure: complete resolution of signs or symptoms of infection and no need to start another antibiotic. Improvement: incomplete resolution of signs or symptoms of infection but no need to start another antibiotic. Failure: death, or need to start another antibiotic. For participants previously assessed as failures, the outcome was failure at subsequent time points.
Time frame: EOT (Day 10 up to 28)
Population: Efficacy was evaluated for the safety analysis set which included all the participants who received at least 1 dose of study medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Linezolid | Number of Participants With Clinical Response | Cure | 57 participants |
| Linezolid | Number of Participants With Clinical Response | Improvement | 31 participants |
| Linezolid | Number of Participants With Clinical Response | Failure | 11 participants |