Clinical trial NCT01021683: The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants
Official title: The Relationship of Defeverscence and Itraconazole Plasma Level Using Sporanox IV as an Empiric Therapy in Immunocompromised Patients Who Have Been Treated With Sporanox Oral Solution as Prophylaxis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Neoplasms
Neutropenia
Fever
Keywords: Hematological neoplasms
Neutropenia
Fever
Itraconazole
Sporanox
Antifungal prophylaxis
Defeverscence
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2009-11-30
Enrollment: 203
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Immunocompromized participants with neutropenic fever who have been treated with itraconazole oral solution as prophylaxis and eligible for intravenous (into the vein) itraconazole in accordance with the local label.

Brief summary: The purpose of this observational study is to investigate whether a sufficient concentration of itraconazole can influence disappearance of a fever (defeverscence) when intravenous (into the vein) itraconazole is administered for resolving unknown neutropenic fever of participants who are given itraconazole oral solution as a prophylaxis under general treatment conditions.

Detailed description: This is a prospective (study following patients forward in time), open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) observational study to examine the correlation between a sufficient blood concentration of itraconazole and disappearance of a fever (defeverscence) when itraconazole injection is administered for resolving unknown neutropenic fever of participants who are given itraconazole oral solution as a prophylaxis under general treatment conditions. The recommended dose of the drug will be 200 milligram (mg), which will be administered intravenously, twice daily for 2 days (a total of 4 doses) and then 200 mg once daily for 12 days. After the administration for a total of 14 days, itraconazole oral solution 200 mg (which is equivalent to 20 ml) twice daily will be continued for a total of 14 days until clinically significant neutropenia is resolved.

Eligibility criteria: Inclusion Criteria:

* Immunocompromised participants with neutropenic fever who have been treated with itraconazole oral solution as prophylaxis
* Female participants who are postmenopausal or received contraceptive operation or refrain from sexual relations and women of childbearing potential should conduct an effective method of birth control (oral contraceptives, injections, intrauterine device, double barrier method, contraceptive patch and male partner's sterilization) before participation and during the study
* Male participants who will not have a baby within 2 months after the completion of itraconazole therapy

Exclusion Criteria:

* Fever due to documented deep-seated fungal infection at the entry into the study, but documented candidemia will be included
* Participants with kidney function related abnormalities with calculated creatinine clearance of 30 milliliter per minute (mL/min) or lower
* Aminotransferase level 5 times or higher of normal limit and total bilirubin level 5 milliliter per deciliter (mL/dL) or higher due to hepatic dysfunction
* Participants with dementia (mental decline) related to head injury and hypoxic brain injury
* Participants with mental illness which may interfere with cooperation in treatment and monitoring condition of the clinical study

Primary outcomes:
measure: Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment
timeFrame: Day 5
Secondary outcomes:
measure: Percentage of Participants With Deferevescence After Administration of Study Treatment
timeFrame: Day 0 up to Day 14
measure: Mean Time to Defervescence in Participants Who Received the Study Treatment
timeFrame: Day 0 up to Day 14
measure: Duration of Neutropenia
timeFrame: Day 0 up to Day 14
measure: Absolute Neutrophil Count (ANC)
timeFrame: Baseline (Day 0)
measure: Percentage of Participants With Defervescence by Plasma Level of Itraconazole
timeFrame: Day 5
measure: Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment
timeFrame: Day 5
measure: Percentage of Participants With Baseline Fungal Infection
timeFrame: Baseline (Day 0)
measure: Plasma Concentration of Itraconazole by Breakthrough Fungal Infection
timeFrame: Day 5
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: