Trial · NCT01401010
Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients
NCT01401010, Phase 4, Completed, Gary E. Stein, Pharm.D.; results first posted 2012-06-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients. Trials, record NCT01401010. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01401010
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients
- NCT number
- NCT01401010
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 12 participants, actual
- Lead sponsor
- Gary E. Stein, Pharm.D.
- Conditions
- Febrile Neutropenia
- Interventions
- Doripenem, doripenem
- First posted
- 2011-07-25
- Last updated
- 2015-10-14
- Results first posted
- 2012-06-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients | 1, 4, 6, 8 hours after at least two doses of drug | To determine the serum pharmacokinetic volume of distribution of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay. |
| Primary | Mean (SD) Doripenem Pharmacokinetic (PK) Elimination Rate Constant Parameter in Febrile Neutropenic Patients | 1, 4, 6, 8 hours after at least two doses of drug | To determine the serum pharmacokinetic elimination rate constant of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay. |
| Primary | Mean (SD) Doripenem Pharmacokinetic (PK) Half Life Parameter in Febrile Neutropenic Patients | 1, 4, 6, 8 hours after at least two doses of drug | To determine the serum pharmacokinetic half life of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay. |
| Primary | Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Febrile Neutropenic Patients | 1, 4, 6, 8 hours after at least two doses of drug | To determine the serum pharmacokinetic clearance of drug of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay. |
| Primary | Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Febrile Neutropenic Patients | 1, 4, 6, 8 hours after at least two doses of drug | To determine the serum pharmacokinetic area under serum curve of doripenem in febrile neutropenic patients with pneumonia. We obtained blood at 1, 4, 6, 8 hours after at least two doses of doripenem and measured these levels (mg/L)by HPLC assay. |
| 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, 4, 6, 8 hours after an infusion of doripenem to determine the PK parameters | Following determination of pharmacokinetic (PK) parameters from patients with febrile neutropenia, Monte Carlo simulations were then conducted to determine time of serum concentrations above the MIC (40% of the time) against Gram-negative isolates. These Gram-negative isolates had a range of minimum inhibitory concentrations (MIC) to Doripenem. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients | 1, 4, 6, 8 hours after at least two doses of drug | Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing. | Liters | MEAN |
| 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, 4, 6, 8 hours after an infusion of doripenem to determine the PK parameters | Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing. | probability of target attainment | NUMBER |
| PRIMARY | Mean (SD) Doripenem Pharmacokinetic (PK) Elimination Rate Constant Parameter in Febrile Neutropenic Patients | 1, 4, 6, 8 hours after at least two doses of drug | Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing. | hour^-1 | MEAN |
| PRIMARY | Mean (SD) Doripenem Pharmacokinetic (PK) Half Life Parameter in Febrile Neutropenic Patients | 1, 4, 6, 8 hours after at least two doses of drug | Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing. | hours | MEAN |
| PRIMARY | Mean (SD) Doripenem Pharmacokinetic (PK) Clearance of Drug Parameter in Febrile Neutropenic Patients | 1, 4, 6, 8 hours after at least two doses of drug | Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing. | Liters/hour | MEAN |
| PRIMARY | Mean (SD) Doripenem Pharmacokinetic (PK) Area Under Serum Curve (mg*h/L) Parameter in Febrile Neutropenic Patients | 1, 4, 6, 8 hours after at least two doses of drug | Each subject received drug and had serum samples drawn at 1, 4, 6, 8 hours after dosing. | milligrams * hour/liters | MEAN |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients | Doripenem 500 mg | 36.7 | Standard Deviation 15.9 | Liters | |
| Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients | Doripenem 1000 mg | 49.9 | Standard Deviation 18.1 | Liters | |
| Mean (SD) Doripenem Pharmacokinetic Volume of Distribution Parameter in Febrile Neutropenic Patients | Combined Results for Both 500 and 1000 mg | 43.9 | Standard Deviation 17.7 | Liters | |
| Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC)) | 500 mg Doripenem 1 Hour Infusion | E. coli MIC: 0.06 mg/L | 1 | probability of target attainment | |
| Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC)) | 500 mg Doripenem 4 Hour Infusion | E. coli MIC: 0.06 mg/L | 1 | probability of target attainment | |
| Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC)) | 1000 mg Doripenem 1 Hour Infusion | E. coli MIC: 0.06 mg/L | 1 | probability of target attainment | |
| Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC)) | 1000 mg Doripenem 4 Hour Infusion | E. coli MIC: 0.06 mg/L | 1 | probability of target attainment | |
| Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC)) | 500 mg Doripenem 1 Hour Infusion | K. pneumoniae MIC: 0.12 mg/L | 0.99 | probability of target attainment | |
| Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC)) | 500 mg Doripenem 4 Hour Infusion | K. pneumoniae MIC: 0.12 mg/L | 1 | probability of target attainment | |
| Monte Carlo Simulations Tested Against Various Gram-negative Isolates and Reported as Probability of Target Attainment (40% Time (fT) > Minimum Inhibitory Concentrations (MIC)) | 1000 mg Doripenem 1 Hour Infusion | K. pneumoniae MIC: 0.12 mg/L | 1 | probability of target attainment |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Doripenem 500 mg | 6 | |
| Overall Study | STARTED | Doripenem 1000 mg | 6 | |
| Overall Study | COMPLETED | Doripenem 500 mg | 5 | |
| Overall Study | COMPLETED | Doripenem 1000 mg | 6 | |
| Overall Study | NOT COMPLETED | Doripenem 500 mg | 1 | |
| Overall Study | NOT COMPLETED | Doripenem 1000 mg | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doripenem 500 mg | ||
| Total, all-cause mortality | Doripenem 1000 mg | ||
| Total, other adverse events | Doripenem 500 mg | 0 | 5 |
| Total, other adverse events | Doripenem 1000 mg | 0 | 6 |
| Total, serious adverse events | Doripenem 500 mg | 0 | 5 |
| Total, serious adverse events | Doripenem 1000 mg | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Doripenem 500 mg vs Doripenem 1000 mg: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01401010
GET https://conductscience.org/api/trials/v1/NCT01401010/results?page=2