NeutropeniaNCT01706562
A Study of Empirical Antifungal Therapy With Itraconazole
An observational study of Neutropenia, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to investigate the overall success rate of itraconazole intravenous treatment for a period of more than 7 days. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Neutropenia
- What is being tested?
- Itraconazole
- Type of treatment
- Injection or infusion
- How many people
- 138 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population consists of patients with hematologic malignancy who visited a study center and were treated with itraconazole intravenous (IV) for more than 7 days.
Who may be able to join
- Patients with neutropenic fever who receive therapy for inhibiting or preventing development of neoplasms (abnormal growth of tissue) or stem cell transplantation (stem cell is a cell whose daughter cells may differentiate into other cell types) for hematologic malignancies (cancers that affect blood, bone marrow and lymph nodes)
- Patients who receive itraconazole intravenous (IV) treatment for more than 7 days
Who cannot join
- Childbearing women who are pregnant or likely to be pregnant during the study period and men who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception
- Fever due to documented fungal infection
- Hepatic dysfunction
- Kidney abnormalities
- Patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
About this study
Official title: Retrospective Observation of Empirical Antifungal Therapy With Itraconazole
The purpose of this study is to investigate the overall success rate of itraconazole intravenous treatment for a period of more than 7 days.
Read the detailed description
This is a retrospective study ie, a study that looks backward in time, usually using medical records and interviews with patients who are already known to have a disease, in patients with itraconazole intravenous prescription as an empirical (based on practical experience) antifungal agent. This study collects baseline information about underlying disease, sign of fungal infection, neutropenia (a decrease in white blood cells), neutropenic fever duration and the reason for discontinuation. Neutropenia is defined as a neutrophil (white blood cell) count of ≤500 cells/mm3 or a count of ≤1000 cells/mm3 with a predicted decrease to ≤500 cells/mm3. Fever is defined as a body temperature ≥38.3 Celsius degrees at least once a day with no definite external factor or a body temperature of ≥38 Celsius degrees continued for at least 1 hour.
- Conditions
- Neutropenia
- Being tested
- Itraconazole
- Keywords
- Neutropenia, Hematologic malignancy, Itraconazole, Fungal infection, Antifungal agent, Neutropenic fever
- Medical subject headings
- Neutropenia, Hematologic Neoplasms, Mycoses, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItraconazoleDrug
Itraconazole intravenous (IV) 200 mg twice daily for 2 days, a total of 4 doses and then 200 mg once daily until clinically significant resolution of neutropenia.
| Study group | Role | What they receive |
|---|---|---|
| Itraconazole | Not described Receives: Drug: Itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of itraconazole treatment when used for more than 7 days
Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.
Measured: From 7 days to approximately 2 weeks
Secondary outcomes (2)
Success rate of itraconazole treatment until neutropenia is resolved
Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.
Measured: Approximately 2 weeks
Drop out rate due to the lack of efficacy of itraconazole treatment
Measured: Approximately 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706562
- Sponsor's protocol ID
- CR017839
- Other IDs
- ITRFUN4055, ITR-KOR-5088
- Status last verified
- Feb 2013
- First submitted
- 11 Oct 2012
- Last updated
- 20 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Observation of Empirical Antifungal Therapy With Itraconazole
- ClinicalTrials.gov ID
- NCT01706562
- Acronym / sponsor ID
- CR017839
- Conditions
- Neutropenia
- Keywords
- Neutropenia, Hematologic malignancy, Itraconazole, Fungal infection, Antifungal agent, Neutropenic fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the overall success rate of itraconazole intravenous treatment for a period of more than 7 days.
Detailed description
This is a retrospective study ie, a study that looks backward in time, usually using medical records and interviews with patients who are already known to have a disease, in patients with itraconazole intravenous prescription as an empirical (based on practical experience) antifungal agent. This study collects baseline information about underlying disease, sign of fungal infection, neutropenia (a decrease in white blood cells), neutropenic fever duration and the reason for discontinuation. Neutropenia is defined as a neutrophil (white blood cell) count of ≤500 cells/mm3 or a count of ≤1000 cells/mm3 with a predicted decrease to ≤500 cells/mm3. Fever is defined as a body temperature ≥38.3 Celsius degrees at least once a day with no definite external factor or a body temperature of ≥38 Celsius degrees continued for at least 1 hour.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Itraconazole | – | Drug: Itraconazole |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population consists of patients with hematologic malignancy who visited a study center and were treated with itraconazole intravenous (IV) for more than 7 days.
Key inclusion criteria (2 listed)
- Patients with neutropenic fever who receive therapy for inhibiting or preventing development of neoplasms (abnormal growth of tissue) or stem cell transplantation (stem cell is a cell whose daughter cells may differentiate into other cell types) for hematologic malignancies (cancers that affect blood, bone marrow and lymph nodes)
- Patients who receive itraconazole intravenous (IV) treatment for more than 7 days
Key exclusion criteria (5 listed)
- Childbearing women who are pregnant or likely to be pregnant during the study period and men who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception
- Fever due to documented fungal infection
- Hepatic dysfunction
- Kidney abnormalities
- Patients who are not eligible for the study participation based on warnings, precautions and contra medications in the package insert of the study drug at the investigator's discretion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ItraconazoleItraconazole intravenous (IV) 200 mg twice daily for 2 days, a total of 4 doses and then 200 mg once daily until clinically significant resolution of neutropenia. | Drug | Itraconazole |
Primary outcome
Success rate of itraconazole treatment when used for more than 7 days
Time frame: From 7 days to approximately 2 weeks
Treatment success is achieved when neutropenia is resolved, ie, when the blood cells count is within the normal reference range.
2 secondary outcomes
Success rate of itraconazole treatment until neutropenia is resolved
Time frame: Approximately 2 weeks
Drop out rate due to the lack of efficacy of itraconazole treatment
Time frame: Approximately 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
Questions about this trial
What is this clinical trial studying?
An observational study of Neutropenia, run by Janssen Korea, Ltd., Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of itraconazole treatment when used for more than 7 days (time frame: From 7 days to approximately 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.