Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002708-17 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to describe the pharmacokinetics of the prescribed echinocandins for septic shock with secondary peritonitis for which intra-abdominal fungal infection is suspected or proven.
The secondary objectives of this study are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | Experimental | The study population consisted of patients admitted to the ICU for septic shock associated with secondary peritonitis and requiring antifungal therapy via echinocandins (micafungin or caspofungin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echinocandins | Drug | The patients included in this protocol require routine treatment with caspofungin or micafungin. Though this intervention is under study, it is not modified by this protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Antifungal treatment plasmatic clearance (L/h) | Day 1 | |
| Antifungal treatment plasmatic clearance (L/h) | Days 3-5 | |
| The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration | Day 1 | |
| The volume of distribution (L) corresponding to plasmatic antifungal treatment concentration | Days 3-5 | |
| Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration | Day 1 | |
| Intercompartmental transfer constant for a bi-compartmental model for plasmatic antifungal treatment concentration | Days 3-5 | |
| The area under the curve for plasmatic antifungal treatment concentrations | Day 1 | |
| The area under the curve for plasmatic antifungal treatment concentrations | Days 3-5 | |
| The maximum concentration for plasmatic antifungal treatment concentrations | Day 1 | |
| The maximum concentration for plasmatic antifungal treatment concentrations | Days 3-5 |
| Measure | Description | Time Frame |
|---|---|---|
| The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin | corresponds to: area under the curve / minimum inhibitory concentration >865 | Day 1 |
| The target Pharmacokinetic/Pharmacodynamic ratio for caspofungin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Claire Roger, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane Women's Hospital | Herston | 4029 | Australia | |||
| CHU de Nîmes - Hôpital Universitaire Carémeau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33846133 | Result | Garbez N, Mbatchi L, Wallis SC, Muller L, Lipman J, Roberts JA, Lefrant JY, Roger C. Prospective Cohort Study of Micafungin Population Pharmacokinetic Analysis in Plasma and Peritoneal Fluid in Septic Patients with Intra-abdominal Infections. Antimicrob Agents Chemother. 2021 Jun 17;65(7):e0230720. doi: 10.1128/AAC.02307-20. Epub 2021 Jun 17. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D010538 | Peritonitis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
Not provided
Not provided
| ID | Term |
|---|---|
| D054714 | Echinocandins |
| D000077336 | Caspofungin |
| D000077551 | Micafungin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D055666 | Lipopeptides |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| The minimum concentration for plasmatic antifungal treatment concentrations | Day 1 |
| The minimum concentration for plasmatic antifungal treatment concentrations | Days 3-5 |
corresponds to: area under the curve / minimum inhibitory concentration >865
| Days 3-5 |
| The target Pharmacokinetic/Pharmacodynamic ratio for micafungin | corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000 | Day 1 |
| The target Pharmacokinetic/Pharmacodynamic ratio for micafungin | corresponds to: area under the curve / minimum inhibitory concentration >285 et 3000 | Days 3-5 |
| The area under the curve for peritoneal antifungal treatment concentrations | Day 1 |
| The area under the curve for peritoneal antifungal treatment concentrations | Days 3-5 |
| The maximum concentration for peritoneal antifungal treatment concentrations | Day 1 |
| The maximum concentration for peritoneal antifungal treatment concentrations | Days 3-5 |
| The minimum concentration for peritoneal antifungal treatment concentrations | Day 1 |
| The minimum concentration for peritoneal antifungal treatment concentrations | Days 3-5 |
| The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio | Day 1 |
| The probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio | Days 3-5 |
| The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio | Day 1 |
| The fraction of the probability of attaining the targeted Pharmacokinetic/Pharmacodynamic ratio | Days 3-5 |
| Nîmes |
| 30029 |
| France |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D059413 | Intraabdominal Infections |
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
| D008055 |
| Lipids |