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

NCT01021683 | Completed Results

• 3 other identifiers: CR016597ITR-KOR-5085ITRFUN4049
• Study Type: observational
• Target: 203
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hematologic Neoplasms; Neutropenia; Fever

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Plasma Level of Itraconazole at 1000 Nanogram Per Milliliter (ng/mL) or Higher After Administration of Study Treatment

  Percentage of participants who achieved more than or equal to 1000 ng/ml level after administration of study treatment were reported. Plasma level of itraconazole was defined as the sum of itraconazole concentration (IC) and hydroxyitraconazole concentration (HIC).

  Day 5

Secondary Outcomes (8)

• Percentage of Participants With Deferevescence After Administration of Study Treatment

  Day 0 up to Day 14

• Mean Time to Defervescence in Participants Who Received the Study Treatment

  Day 0 up to Day 14

• Duration of Neutropenia

  Day 0 up to Day 14

• Absolute Neutrophil Count (ANC)

  Baseline (Day 0)

• Percentage of Participants With Defervescence by Plasma Level of Itraconazole

  Day 5

Study Arms (1)

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.

Drug: Itraconazole

Interventions

Itraconazole 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.

Itraconazole

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood cultures

MeSH Terms

Conditions

Hematologic Neoplasms; Neutropenia; Fever

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Results Point of Contact

• Title: Clinical Research Associate
• Organization: Clinical Research Team, Medical Affairs, Medical Dept. Janssen Korea

+82-2-2094-4879

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 30, 2009
• Study Start: July 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 12, 2013
• Results First Posted: July 3, 2013

Record last verified: 2013-07