N/A
N=203
The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants
Hematologic Neoplasms · Neutropenia · Fever
Bottom Line
View on ClinicalTrials.gov: NCT01021683 ↗Enrolled (actual)
203
Serious AEs
13.8%
Results posted
Jul 2013
Primary outcome: Primary: Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment — 68.0 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Itraconazole (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Janssen Korea, Ltd., Korea
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment |
68.0 | — |
| SECONDARY Percentage of Participants With Deferevescence After Administration of Study Treatment |
87.3 | — |
| SECONDARY Mean Time to Defervescence in Participants Who Received the Study Treatment |
3.14 | — |
| SECONDARY Duration of Neutropenia |
2.64 | — |
| SECONDARY Absolute Neutrophil Count (ANC) |
56.26 | — |
| SECONDARY Percentage of Participants With Defervescence by Plasma Level of Itraconazole |
70.8; 95.1 | — |
| SECONDARY Plasma Concentration of Itraconazole by Overall Success Rate (OSR) in Participants Who Received the Study Treatment |
2328.10; 1690.90 | — |
| SECONDARY Percentage of Participants With Baseline Fungal Infection |
5.3 | — |
| SECONDARY Plasma Concentration of Itraconazole by Breakthrough Fungal Infection |
2155.70; 1864.20 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01021683). 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.