The Relationship of Defeverscence and Itraconazole Plasma Level Study
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Purpose
The objective for this study is to investigate whether a sufficient concentration of itraconazole can influence disappearance of a fever (defeverscence) when itraconazole IV (given intravenously directly into the vein) is administered for resolving unknown neutropenic fever of patients who are given itraconazole oral solution as a prophylaxis under general treatment conditions.
| Condition | Intervention | Phase |
|---|---|---|
|
Hematological Malignancies Neutropenia Fever |
Drug: itraconazole injection |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | The Relationship of Defeverscence and Itraconazole Plasma Level Using Itraconazole IV as an Empiric Therapy in Immunocompromised Patients Who Had Previously Been Treated With Itraconazole Oral Solution as Prophylaxis |
- Blood sample to examine the itraconazole trough level (the lowest level of a medicine that is present in the body) [ Time Frame: Prior to 1st and 7th administration of itraconazole injection ] [ Designated as safety issue: No ]
- Blood cultures (a laboratory test on a sample of blood) to identify fungus [ Time Frame: Drawn prior to 1st itraconazole intection, once on any day from day 1 through day 4, and on day 5. ] [ Designated as safety issue: No ]
- Body temperature, WBC (Whie Blood Cell Count)/ANC (Absolute Neutrophile Count [ Time Frame: Once a day during itraconazole injection treatment period ] [ Designated as safety issue: No ]
- Defervescence timing [ Time Frame: When fever is resolved ] [ Designated as safety issue: No ]
| Enrollment: | 203 |
| Study Start Date: | July 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
001
itraconazole injection 200 mg twice daily for 2 days and then 200 mg daily for 12 days
|
Drug: itraconazole injection
200 mg twice daily for 2 days and then 200 mg daily for 12 days
|
Detailed Description:
This is a prospective, open-label, multicenter, and observational study executed in 20 organizations nationwide with around 250 patients, in order to examine the correlation between a sufficient blood concentration of itraconazole and disappearance of a fever (defeverscence) when a itraconazole injection is administered for resolving unknown neutropenic fever of patients who are given itraconazole oral solution as a prophylaxis under general treatment conditions. It is recommended that the IV form of the drug be administered 200 mg 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 (20 ml) twice daily should be continued for a total of 14 days until clinically significant resolution of neutropenia resolves.
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Immunocompromised patients with neutropenic fever who have been treated with itraconazole oral solution as prophylaxis and elgible for itraconazole iv in accordance with the local label.
Inclusion Criteria:
- Immunocompromised patients with neutropenic fever who have been treated with itraconazole oral solution as prophylaxis
- Female patients who are postmenopausal or received contraceptive operation or refrain from sexual relations. 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 patients 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
- Patients with kidney function abnormalities with calculated creatinine clearance of 30mL/min or lower
- Aminotransferase level > 5 X Upper Limit of Normal and total bilirubin level > 5 mL/dL due to hepatic dysfunction
Contacts and Locations More Information
No publications provided
| Responsible Party: | Medical Director, Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT01021683 History of Changes |
| Other Study ID Numbers: | CR016597, ITR-KOR-5085 |
| Study First Received: | November 25, 2009 |
| Last Updated: | August 13, 2012 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Janssen Korea, Ltd., Korea:
|
Itraconazole trough plasma level Antifungal prophylaxis Defeverscence rate Sporanox |
Additional relevant MeSH terms:
|
Neoplasms Neutropenia Hematologic Neoplasms Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Neoplasms by Site Itraconazole |
Hydroxyitraconazole 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antifungal Agents Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013