Clinical trial · Observational
Observational Study Investigating the Response Rate of Itraconazole Injection in Treating Immunocompromised Patients
Efficacy According to Treatment Timing in Immunocompromised Patients Treated With Itraconazole Injection as an Empiric Antifungal Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this observational study is to examine the rate at which elevated body temperature (fever) is relieved by an itraconazole injection administrated to patients experiencing neutropenic fever . A neutropenic fever is an elevated body temperature that occurs at a time when the patient's white blood cell count is low. White blood cells aid the body's normal defenses against infection, so a fever during this period might make it difficult for the patient to fight infections.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fever | — | UNRESOLVED | — |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pts. w/ neutropenic fever associated w/ hematologic malignancy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 001
- description
- Pts. w/ neutropenic fever associated w/ hematologic malignancy Itraconazole 200 mg twice daily for 2 days for a total of 4 doses then 200 mg once daily for 12 days. After 14 days of IV administration itraconazole oral solution 200 mg twice daily should be continued for a total of 14 days until clinically significant resolution of neutropenia resolves
- interventionNames
- Drug: Pts. w/ neutropenic fever associated w/ hematologic malignancy
Primary outcomes (1)
- measure
- Frequency rate at which fever is resolved and the time to fever resolution
- timeFrame
- after completion of the treatment of 3 to 14 days and after 7 days of follow up period
Secondary outcomes (1)
- measure
- Defervescence rate according to baseline result of Chest X-ray, CT (Computed tomography, a medical imaging method), Galactomannan test (diagnosis test for fungal infection)
- timeFrame
- after completion of 3 to 14 days of treatment and after 7 days of follow up period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with neutropenic fever who receive antineoplastic therapy or stem cell transplantation for acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma * Patients who are recommended to receive itraconazole injection for treatment of acute leukemia, hodgkin's lymphoma, non-hodgkin's lymphoma, myelodysplastic syndrome, and multiple myeloma Exclusion Criteria: * Childbearing women who are pregnant or likely to be pregnant during the study period and male patients who are neither infertile nor willing to refrain from sexual relations but whose partner does not conduct an effective contraception (implant, injections, oral contraceptives, intrauterine device, etc.) * Fever due to documented deep-seated fungal infection at the entry into the study (documented candidemia will be included) * Significant hepatic and renal dysfunction * Patients who, at the discretion of the investigator, are not eligible for the study participation based on warnings, precautions and contraindicated medications as listed in the package insert of the drug
References
Publications (1)
- DERIVEDKim SJ, Cheong JW, Min YH, Choi YJ, Lee DG, Lee JH, Yang DH, Lee SM, Kim SH, Kim YS, Kwak JY, Park J, Kim JY, Kim HG, Kim BS, Ryoo HM, Jang JH, Kim MK, Kang HJ, Cho IS, Mun YC, Jo DY, Kim HY, Park BB, Kim JS. Success rate and risk factors for failure of empirical antifungal therapy with itraconazole in patients with hematological malignancies: a multicenter, prospective, open-label, observational study in Korea. J Korean Med Sci. 2014 Jan;29(1):61-8. doi: 10.3346/jkms.2014.29.1.61. Epub 2013 Dec 26. PMID 24431907