## Protocol Section
### Identification Module
**NCT ID:** NCT05275179

**Brief Title:** Pharmacokinetic of Posaconazole in Critically Ill Patients

**Official Title:** Pharmacokinetic of Intravenous Posaconazole in Critically Ill Patients

#### Organization Study ID Info
**ID:** PV7263
#### Organization
**Class:** OTHER
**Full Name:** Universitätsklinikum Hamburg-Eppendorf
### Status Module
#### Completion Date
**Date:** 2022-11-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-11-08

**Type:** ACTUAL

**Last Update Submit Date:** 2022-11-06

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-03-30

**Type:** ACTUAL

#### Start Date
**Date:** 2021-02-11

**Type:** ACTUAL

**Status Verified Date:** 2022-11

#### Study First Post Date
**Date:** 2022-03-11
**Type:** ACTUAL
**Study First Submit Date:** 2022-01-21
**Study First Submit QC Date:** 2022-03-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Universitätsklinikum Hamburg-Eppendorf

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial.

**Detailed Description:** The posaconazole pharmacokinetic in critically ill patients will be studied in a prospective, non-interventional, monocentric observational trial. Plasma specimens will be retrieved on consecutive days (max. 7 days) in order to measure posaconazole levels during the treatment episode.

### Conditions Module

**Conditions:**

- Therapeutic Drug Monitoring

- Critical Illness

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 10

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Therapeutic Drug Monitoring of posaconzole is performed by measuring posaconazole concentrations in serum

**Intervention Names:**

- Other: Posaconazole Therapeutic Drug Monitoring

**Label:** Posaconazole Therapeutic Drug Monitoring

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Posaconazole Therapeutic Drug Monitoring

**Description:** Therapeutic Drug Monitoring is performed by measuring posaconazole concentrations in serum on seven consecutive days (anticipated).

**Name:** Posaconazole Therapeutic Drug Monitoring

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Measurement of posaconazole concentration in serum

**Measure:** Posaconazole Drug Exposure

**Time Frame:** seven days from therapystart

#### Secondary Outcomes

**Description:** Analysis of Peak Plasma Concentration (Cmax) for posaconazole in the given cohort.

**Measure:** population-pharmacokinetic analysis 1

**Time Frame:** 12 months after close out

**Description:** Analysis of Area under the plasma concentration versus time curve (AUC) for posaconazole in the given cohort.

**Measure:** population-pharmacokinetic analysis 2

**Time Frame:** 12 months after close out

**Description:** Analysis of Monte-Carlo-Simulations in order to asses novel dosing regimens for posaconazole.

**Measure:** Evaluation of probability of target attainment of posaconazole

**Time Frame:** 12 months after close out

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* treatment with intravenous posaconazole
* critically ill patient
* written declaration of consent

Exclusion Criteria:

- no declaration of consent

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Critically ill patients treated with posaconazole intravenously.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Hamburg

**Country:** Germany

**Facility:** University Medical Center Hamburg-Eppendorf

**Zip:** 20246

#### Overall Officials

**Official 1:**

**Affiliation:** Universitätsklinikum Hamburg-Eppendorf

**Name:** Dominic Wichmann, Prof

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M19010

- Name: Critical Illness

- Relevance: HIGH

- As Found: Critical Illness

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016638

- Term: Critical Illness

### Intervention Browse Module - Ancestors

- ID: D000000935

- Term: Antifungal Agents

- ID: D000000890

- Term: Anti-Infective Agents

- ID: D000014344

- Term: Trypanocidal Agents

- ID: D000000981

- Term: Antiprotozoal Agents

- ID: D000000977

- Term: Antiparasitic Agents

- ID: D000058888

- Term: 14-alpha Demethylase Inhibitors

- ID: D000065607

- Term: Cytochrome P-450 Enzyme Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000065088

- Term: Steroid Synthesis Inhibitors

- ID: D000006727

- Term: Hormone Antagonists

- ID: D000006730

- Term: Hormones, Hormone Substitutes, and Hormone Antagonists

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M219015

- Name: Posaconazole

- Relevance: HIGH

- As Found: Venous Thromboembolism

- ID: M6252

- Name: Clotrimazole

- Relevance: LOW

- As Found: Unknown

- ID: M11796

- Name: Miconazole

- Relevance: LOW

- As Found: Unknown

- ID: M4254

- Name: Antifungal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4214

- Name: Anti-Infective Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4298

- Name: Antiprotozoal Agents

- Relevance: LOW

- As Found: Unknown

- ID: M4294

- Name: Antiparasitic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M30537

- Name: Cytochrome P-450 Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

- ID: M9788

- Name: Hormone Antagonists

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000101425

- Term: Posaconazole

### Misc Info Module

- Version Holder: 2024-05-24
