The Relationship of Defeverscence and Itraconazole Plasma Level Study in Immunocompromised Participants

NCT ID: NCT01021683

Last Updated: 2013-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 203 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-07-31

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.

Conditions

Hematologic Neoplasms; Neutropenia; Fever

Keywords

Hematological neoplasms; Neutropenia; Fever; Itraconazole; Sporanox; Antifungal prophylaxis; Defeverscence

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Itraconazole

Participants who have been receiving itraconazole will be observed prospectively. Itraconazole will be administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, followed by itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia is recovered.

Itraconazole

Intervention Type: DRUG

Itraconazole will be administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, followed by itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia is recovered.

Interventions

Itraconazole

Itraconazole will be administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, followed by itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia is recovered.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Other Identifiers

ITR-KOR-5085

Identifier Type: -

Identifier Source: secondary_id

ITRFUN4049

Identifier Type: -

Identifier Source: secondary_id

CR016597

Identifier Type: -

Identifier Source: org_study_id