A Phase 4 interventional study of Ceftaroline and Levofloxacin in Pneumonia, Bacterial and Community-acquired, sponsored by Gary E. Stein, Pharm.D.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-12.
Sponsored by Gary E. Stein, Pharm.D. · Phase 4, Interventional, and Treatment
This study will further analyze the use of ceftaroline for CABP and compare its potential to eradicate bacterial pathogens to standard fluoroquinolone therapy. The enhanced spectrum of ceftaroline compared to levofloxacin may be further highlighted from this investigation.
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's enrollment of 12 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Gary E. Stein, Pharm.D. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Pharmacodynamics
Drug: Levofloxacin
Pharmacodynamics
Drug: Ceftaroline
600 mg Q12h
Also known as: Teflaro
750 mg QD
Also known as: Levaquin
Serum Cidal Activity as Tested Against Staphylococcus Aureus Isolates and Reported as Ex-vivo Effect (Log Inhibition of Growth)
Serum cidal activity of serum collected at 2 hour (levofloxacin) and 12 hour (ceftaroline) time points from the patients was tested against methyicillin-sensitive staphylococcus aureus isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth). These staphylococcus aureus isolates had a range of minimum inhibitory concentrations (MIC) to Levofloxacin, 0.5, 1.0, 2.0, and 4.0 and the MIC's to Ceftaroline were 0.125, 0.19, 0.094, 0.094, respectively.
Time frame: 2 hour (levofloxacin) and 12 hour (ceftaroline) after receiving the drug
Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients
To determine the serum pharmacokinetic volume of distribution of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Time frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients
To determine the serum pharmacokinetic clearance of drug parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Time frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients
To determine the serum pharmacokinetic half life parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Time frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients.
To determine the serum pharmacokinetic Area Under Serum Curve parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
Time frame: 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion
| Milestone | Levofloxacin | Ceftaroline |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 6 |
| Not completed | 0 | 0 |
To determine the serum pharmacokinetic volume of distribution of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
| Liters | Levofloxacin | Ceftaroline |
|---|---|---|
| Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic Volume of Distribution Parameter in Community-Acquired Bacterial Pneumonia Patients | 92 ± 15 | 20.6 ± 5.2 |
To determine the serum pharmacokinetic clearance of drug parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
| liters per hour | Levofloxacin | Ceftaroline |
|---|---|---|
| Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Community-Acquired Bacterial Pneumonia Patients | 9.4 ± 3.1 | 7.3 ± 1.5 |
To determine the serum pharmacokinetic half life parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
| hours | Levofloxacin | Ceftaroline |
|---|---|---|
| Mean (SD) Ceftaroline and Levofloxacin Pharmacokinetic (PK) Half Life Parameter in Community-Acquired Bacterial Pneumonia Patients | 7.2 ± 1.4 | 1.9 ± 0.2 |
To determine the serum pharmacokinetic Area Under Serum Curve parameter of ceftaroline and levofloxacin in community-acquired bacterial pneumonia patients. We obtained blood at 2, 6 and 12 hours after at least 2 days of treatment and a 1-hr antibiotic infusion and measured these levels (mg/L)by LC/MS/MS assay.
| mg*hr/L | Levofloxacin | Ceftaroline |
|---|---|---|
| Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Community-Acquired Bacterial Pneumonia Patients. | 87 ± 23 | 90 ± 15 |
Serum cidal activity of serum collected at 2 hour (levofloxacin) and 12 hour (ceftaroline) time points from the patients was tested against methyicillin-sensitive staphylococcus aureus isolates and the ex-vivo effect reported as log inhibition (logrithmic measurement of the decrease in microbiological growth). These staphylococcus aureus isolates had a range of minimum inhibitory concentrations (MIC) to Levofloxacin, 0.5, 1.0, 2.0, and 4.0 and the MIC's to Ceftaroline were 0.125, 0.19, 0.094, 0.094, respectively.
| Log inhibition | Log Inhibition of 0.5mg/L MIC Levofloxacin | Log Inhibition of 1.0mg/L MIC Levofloxacin | Log Inhibition of 2.0mg/L MIC Levofloxacin | Log Inhibition of 4.0mg/L MIC Levofloxacin |
|---|---|---|---|---|
| Levofloxacin | 2 | 4 | 1 | 1 |
| Ceftaroline | 3 | 5 | 3 | 3 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Levofloxacin | — | 0/6 (0%) | 0/6 (0%) |
| Ceftaroline | — | 0/6 (0%) | 0/6 (0%) |
| Age, Categorical(Participants) | Levofloxacin | Ceftaroline | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 6 | 9 |
| >=65 years | 3 | 0 | 3 |
| Age, Continuous(years) | Levofloxacin | Ceftaroline | Total |
|---|---|---|---|
| Mean | 56 (26 to 72) | 52 (40 to 61) | 54 (26 to 72) |
| Sex: Female, Male(Participants) | Levofloxacin | Ceftaroline | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 2 | 1 | 3 |
| Region of Enrollment(participants) | Levofloxacin | Ceftaroline | Total |
|---|---|---|---|
| United States | 6 | 6 | 12 |
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Gary E. Stein, Pharm.D.