Skin and Subcutaneous Tissue Bacterial Infections
Conditions
Brief summary
The purpose of this study is to compare clinical response to the measurement techniques of several objective measures of clinical efficacy for use in future ABSSSI (Acute Bacterial Skin and Skin Structure Infection) clinical trials
Interventions
DRUGDelafloxacin
300mg IV every 12 hours for 5-14 days
DRUGLinezolid
600mg IV every 12 hours for 5-14 days
DRUGVancomycin
15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days
Sponsors
Melinta Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (≥ 18 years of age) men or women * Sexually active women and men with partners of childbearing potential must agree to use an acceptable form of contraception as determined by the investigator during participation in the study and for 30 days after the final dose of study drug * Female partners of male subjects should also use an additional reliable method of contraception during study and for 30 days after the final dose of study drug * Subjects must have a diagnosis of ABSSSI - one or more of the following 4 infection types: cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection * Subjects must have lymph node enlargement due to the present infection or at least one of the following symptoms of systemic infection: fever ≥ 38°C, lymphangitis, WBC (white blood cell) count ≥ 15,000 cells/μL, elevated C-reactive protein (\> 5.0mg/L) * In the opinion of the investigator, the subject must require and be a suitable candidate for IV antibiotic therapy
Exclusion criteria
* A medical history of significant hypersensitivity or allergic reaction to quinolones, linezolid, vancomycin, or vancomycin derivatives * Women who are pregnant or lactating * Any chronic or underlying skin condition at the site of infection that may complicate the assessment of response * Subjects with any of the following: infection involving prosthetic materials or foreign bodies, infection associated with a human or animal bite, osteomyelitis, decubitus ulcer, diabetic foot ulcer, septic arthritis, mediastinitis, necrotizing fasciitis, anaerobic cellulitis, or synergistic necrotizing cellulitis, myositis, tendinitis, endocarditis, toxic shock syndrome, gangrene, burns covering ≥ 10% of body surface area, severely impaired arterial blood supply, current evidence of deep vein thrombosis or superficial thrombophlebitis * Minor abscesses, unless present with one of the ABSSSI types * Any infection expected to require other antimicrobial agents in addition to study drug * Receipt of \> 24 hours of systemic antibiotic therapy in the 14 days before enrollment unless one of the following is documented: the subject received a single dose of a short-acting antibacterial drug 3 or more days before clinical trial enrollment for surgical prophylaxis or recently completed treatment with an antibacterial drug for an infection other than ABSSSI and the drug does not have antibacterial activity against bacterial pathogens that cause ABSSSI * Receipt of more than 1 dose of a potentially effective antibacterial agent for treatment of the ABSSSI under study prior to enrollment * Receipt of chronic anti-inflammatory therapy for longer than 14 days before enrollment * Severely compromised immune systems * Subjects taking any medicinal product which inhibits monoamine oxidases A or B or within 2 weeks of Screening * Hypertension as defined by a systolic blood pressure of ≥ 180 mmHg or a diastolic blood pressure of ≥110 mmHg with confirmed re-check within 20 minutes of initial reading * Subjects with pheochromocytoma, thyrotoxicosis and/or subjects taking any of the following types of medications: sympathomimetic agents, vasopressive agents, dopaminergic agents, or other agents with the potential for serotonergic interactions * Subjects with carcinoid syndrome and/or subjects taking any of the following medications: serotonin re-uptake inhibitors, tricyclic antidepressants, serotonin 5-HT1 (serotonin receptor) receptor agonists, meperidine, or buspirone * Known history of liver disease * History of severe renal impairment * Life expectancy of \< 3 months * Any underlying disease that, in the opinion of the investigator, could interfere with the subject's ability to participate in the study * Subjects previously randomized in this study or in who have received a dose of an investigational drug within 30 days of randomization * Subjects \> 140 kg in body weight
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up | Follow-up (Day 14 ± 1) | The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid | Through Day 3 (± 1 day) | Blood samples for pharmacokinetic analyses were drawn from all subjects on Day 3 (± 1 day) of treatment within 2 hours before the first study drug infusion and at 1, 2, 3, 5, and 12 hours (ie, immediately before the second dose) after the start of the first study drug infusion. An analytical, validated method was used to analyze samples and determine human plasma concentrations. The primary pharmacokinetic parameter calculated was area under the plasma concentration - time curve from time 0 extrapolated to infinity (AUCinf, ug\*h/mL). |
| The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | Baseline, Days 1, 5, Follow-up (FU), and late Follow-up (LFU) | CRP Levels (g/m3) were analyzed from blood samples collected from subjects at Baseline and various time points throughout the study. Change in baseline values were analyzed using an analysis of covariance (ANCOVA) model with treatment, infection category, and prior antimicrobial therapy as fixed effects and the baseline measure as the covariate. |
| Erythema Clinical Success | 48 - 72 hours | The number of ITT subjects who had cessation of erythema within 48-72 hours, based on digital measurements, as well as resolution/absence of fever. Cessation was defined as a percentage change from baseline in total area of erythema/induration that is less than or equal to 0%. |
| Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Follow-up (Day 14 ± 1) | Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population. |
| Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population | Follow-up (Day 14 ± 1) | The success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure. |
| Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Follow-up (Day 14 ± 1) | Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population. |
Countries
United States
Participant flow
Recruitment details
This study targeted patients with ABSSSI (acute bacterial skin and skin structure infections), defined as cellulitis/erysipelas, wound infection, major cutaneous abscess, or burn infection; the minimum surface area was to be 75 square centimeters.
Participants by arm
| Arm | Count |
|---|---|
| Delafloxacin IV (Intravenous) Delafloxacin 300 mg, BID (twice a day) | 81 |
| Linezolid Linezolid 600 mg, BID | 77 |
| Vancomycin Vancomycin 15 mg/kg or up to 1250 mg/dose, BID | 98 |
| Total | 256 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 1 | 4 |
| Overall Study | Early termination | 0 | 0 | 1 |
| Overall Study | Investigator unblinded | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 6 | 8 |
| Overall Study | Noncompliance | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 1 | 2 |
| Overall Study | Protocol Violation | 0 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 5 | 2 |
Baseline characteristics
| Characteristic | Linezolid | Delafloxacin IV (Intravenous) | Vancomycin | Total |
|---|---|---|---|---|
| Age, Continuous | 44.8 years STANDARD_DEVIATION 14.91 | 39.7 years STANDARD_DEVIATION 14.26 | 44.8 years STANDARD_DEVIATION 15.54 | 43.2 years STANDARD_DEVIATION 15.08 |
| Baseline Infection Category Burn infection | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Baseline Infection Category Cellulitis/erysipelas | 31 Participants | 38 Participants | 44 Participants | 113 Participants |
| Baseline Infection Category Major cutaneous abscess | 24 Participants | 22 Participants | 29 Participants | 75 Participants |
| Baseline Infection Category Not assessed | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Baseline Infection Category Wound infection | 20 Participants | 19 Participants | 23 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 19 Participants | 27 Participants | 57 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 66 Participants | 62 Participants | 71 Participants | 199 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Pathogens isolated at baseline Subjects with at least 1 MRSA | 37 Participants | 34 Participants | 35 Participants | 106 Participants |
| Pathogens isolated at baseline Subjects with at least 1 MSSA | 16 Participants | 11 Participants | 26 Participants | 53 Participants |
| Pathogens isolated at baseline Subjects with at least 1 pathogen | 57 Participants | 51 Participants | 67 Participants | 175 Participants |
| Pathogens isolated at baseline Subjects with at least 1 Staphylococcus aureus | 53 Participants | 45 Participants | 61 Participants | 159 Participants |
| Pathogens isolated at baseline Subjects with multiple pathogens | 15 Participants | 6 Participants | 8 Participants | 29 Participants |
| Pathogens isolated at baseline Subjects without pathogens | 20 Participants | 30 Participants | 31 Participants | 81 Participants |
| Pathogens isolated at baseline Subjects with positive blood cultures | 6 Participants | 0 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 10 Participants | 15 Participants | 40 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 58 Participants | 63 Participants | 74 Participants | 195 Participants |
| Sex: Female, Male Female | 25 Participants | 32 Participants | 47 Participants | 104 Participants |
| Sex: Female, Male Male | 52 Participants | 49 Participants | 51 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 59 / 78 | 54 / 75 | 62 / 96 |
| serious Total, serious adverse events | 5 / 78 | 2 / 75 | 6 / 96 |
Outcome results
Primary
Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up
The primary efficacy endpoint was the success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.
Time frame: Follow-up (Day 14 ± 1)
Population: ITT (intent-to-treat) population, defined as all subjects who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delafloxacin IV | Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up | 57 Participants |
| Linezolid | Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up | 50 Participants |
| Vancomycin | Investigator's Assessment of Clinical Response in the ITT (Intent-to-treat) Population at Follow-up | 53 Participants |
Secondary
Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population
The success rate, defined as (cure)/(cure + failure), and expressed as a percentage. Cure was defined as the complete resolution of all baseline signs and symptoms of ABSSSI and follow-up and late follow-up. If erythema was the only sign of infection present at follow-up and it was then absent at late follow-up, the case was classified as a Cure.
Time frame: Follow-up (Day 14 ± 1)
Population: Microbiological ITT Population (MITT)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delafloxacin IV | Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population | 19 Participants |
| Linezolid | Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population | 21 Participants |
| Vancomycin | Clinical Response in Subjects With Infections Caused by MRSA - Microbiological ITT (MITT) Population | 21 Participants |
Secondary
Erythema Clinical Success
The number of ITT subjects who had cessation of erythema within 48-72 hours, based on digital measurements, as well as resolution/absence of fever. Cessation was defined as a percentage change from baseline in total area of erythema/induration that is less than or equal to 0%.
Time frame: 48 - 72 hours
Population: ITT (intent-to-treat) population, defined as all subjects who were randomized.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delafloxacin IV | Erythema Clinical Success | 61 Participants |
| Linezolid | Erythema Clinical Success | 56 Participants |
| Vancomycin | Erythema Clinical Success | 69 Participants |
Secondary
Microbiological Response Rate in All Subjects (Microbiological Evaluable Population)
Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population.
Time frame: Follow-up (Day 14 ± 1)
Population: Microbiologically Evaluable (ME) Population - All Subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Delafloxacin IV | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Documented Eradicated | 0 Participants |
| Delafloxacin IV | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Presumed Eradicated | 30 Participants |
| Delafloxacin IV | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Documented Persisted | 0 Participants |
| Delafloxacin IV | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Presumed Persisted | 4 Participants |
| Linezolid | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Presumed Persisted | 10 Participants |
| Linezolid | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Documented Eradicated | 0 Participants |
| Linezolid | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Documented Persisted | 0 Participants |
| Linezolid | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Presumed Eradicated | 42 Participants |
| Vancomycin | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Presumed Persisted | 6 Participants |
| Vancomycin | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Presumed Eradicated | 32 Participants |
| Vancomycin | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Documented Persisted | 1 Participants |
| Vancomycin | Microbiological Response Rate in All Subjects (Microbiological Evaluable Population) | Documented Eradicated | 0 Participants |
Secondary
Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population
Based on the results of the baseline and follow up cultures and susceptibility testing, together with the clinical response assigned by the investigator, the sponsor determined a microbiological response for subjects in the ME population.
Time frame: Follow-up (Day 14 ± 1)
Population: Microbiologically Evaluable (ME) Population - MRSA Subjects
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Delafloxacin IV | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Documented Eradicated | 0 Participants |
| Delafloxacin IV | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Presumed Eradicated | 18 Participants |
| Delafloxacin IV | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Documented Persisted | 0 Participants |
| Delafloxacin IV | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Presumed Persisted | 3 Participants |
| Linezolid | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Presumed Persisted | 3 Participants |
| Linezolid | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Documented Eradicated | 0 Participants |
| Linezolid | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Documented Persisted | 0 Participants |
| Linezolid | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Presumed Eradicated | 23 Participants |
| Vancomycin | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Presumed Persisted | 4 Participants |
| Vancomycin | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Presumed Eradicated | 20 Participants |
| Vancomycin | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Documented Persisted | 1 Participants |
| Vancomycin | Microbiological Response Rate in Subjects With MRSA (Methicillin Resistant Staphylococcus Aureus) in Microbiological Evaluable (ME) Population | Documented Eradicated | 0 Participants |
Secondary
Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid
Blood samples for pharmacokinetic analyses were drawn from all subjects on Day 3 (± 1 day) of treatment within 2 hours before the first study drug infusion and at 1, 2, 3, 5, and 12 hours (ie, immediately before the second dose) after the start of the first study drug infusion. An analytical, validated method was used to analyze samples and determine human plasma concentrations. The primary pharmacokinetic parameter calculated was area under the plasma concentration - time curve from time 0 extrapolated to infinity (AUCinf, ug\*h/mL).
Time frame: Through Day 3 (± 1 day)
Population: AUCinf (ug\*h/mL) for delafloxacin, linezolid, and vancomycin are presented only for those subjects with PK samples collected.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Delafloxacin IV | Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid | 23.4 ug*h/mL | Standard Deviation 11.7 |
| Linezolid | Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid | 266.8 ug*h/mL | Standard Deviation 88.63 |
| Vancomycin | Pharmacokinetic (PK) Parameter, Area Under Curve, (AUCinf, ug*h/mL), in Subjects Administered Delafloxacin, Vancomycin, and Linezolid | 106.0 ug*h/mL | Standard Deviation 47.33 |
Secondary
The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP)
CRP Levels (g/m3) were analyzed from blood samples collected from subjects at Baseline and various time points throughout the study. Change in baseline values were analyzed using an analysis of covariance (ANCOVA) model with treatment, infection category, and prior antimicrobial therapy as fixed effects and the baseline measure as the covariate.
Time frame: Baseline, Days 1, 5, Follow-up (FU), and late Follow-up (LFU)
Population: Only subjects from ITT population with CRP levels evaluated were included in outcome measure analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Delafloxacin IV | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | FU | 9.4 g/m3 | Standard Deviation 17.65 |
| Delafloxacin IV | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | Day 5 | 19.6 g/m3 | Standard Deviation 35.97 |
| Delafloxacin IV | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | Baseline | 46.6 g/m3 | Standard Deviation 70.66 |
| Delafloxacin IV | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | Day 1 | 44.2 g/m3 | Standard Deviation 67.63 |
| Delafloxacin IV | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | LFU | 10.8 g/m3 | Standard Deviation 17.47 |
| Linezolid | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | Day 5 | 19.5 g/m3 | Standard Deviation 22.63 |
| Linezolid | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | Baseline | 55.2 g/m3 | Standard Deviation 69.7 |
| Linezolid | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | Day 1 | 49.6 g/m3 | Standard Deviation 58.56 |
| Linezolid | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | FU | 11.9 g/m3 | Standard Deviation 28.71 |
| Linezolid | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | LFU | 9.3 g/m3 | Standard Deviation 16.46 |
| Vancomycin | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | LFU | 12.6 g/m3 | Standard Deviation 27.1 |
| Vancomycin | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | FU | 12.1 g/m3 | Standard Deviation 26.04 |
| Vancomycin | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | Baseline | 49.3 g/m3 | Standard Deviation 56.14 |
| Vancomycin | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | Day 5 | 26.5 g/m3 | Standard Deviation 48.44 |
| Vancomycin | The Levels of Inflammation Were Examined by Measuring a Surrogate, C-Reactive Protein (CRP) | Day 1 | 49.8 g/m3 | Standard Deviation 61.66 |