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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Fever; Hematologic Neoplasms; Neutropenia

Treatments: Drug: Itraconazole

Study type: Observational

Funder types: Industry

Identifiers

NCT01021683

CR016597

ITRFUN4049

ITR-KOR-5085

Details and patient eligibility

About

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.

Full 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.

Enrollment: 203 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

203 participants in 1 patient group

Itraconazole

Description:

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.

Treatment:

Drug: Itraconazole