Phase 4
Completed N=12
Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients
Source: ClinicalTrials.gov NCT01401010 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcomePrimary: Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients — 36.7; 49.9; 43.9 Liters
Summary
Primary: To determine the serum pharmacokinetics (PK) of doripenem in febrile neutropenic patients.
Secondary: Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT)> minimum inhibitory concentration (MIC))
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients |
36.7; 49.9; 43.9 | — |
| PRIMARY Mean (SD) Doripenem Pharmacokinetic (PK) Elimination Rate Constant Parameter in Febrile Neutropenic Patients |
0.36; 0.38; 0.37 | — |
| PRIMARY Mean (SD) Doripenem Pharmacokinetic (PK) Half Life Parameter in Febrile Neutropenic Patients |
2.2; 2.4; 2.3 | — |
| PRIMARY Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Febrile Neutropenic Patients |
11.9; 16.6; 14.4 | — |
| PRIMARY Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Febrile Neutropenic Patients |
47.1; 66.4; 57.6 | — |
| SECONDARY Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC)) |
1; 1; 1; 1; 0.99; 1 | — |
Eligibility Criteria
Inclusion Criteria
- adult neutropenic (< 500 cells) patients who are febrile
Exclusion Criteria
- Patients with Creatinine Clearance < 30 ml/min or allergy to carbapenems will be excluded.
Data sourced from ClinicalTrials.gov (NCT01401010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.