A study of drug concentrations of Young Kids with a fever
- Conditions
- eutropenic immunosuppressedTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-005030-54-Outside-EU/EEA
- Lead Sponsor
- Merck & Co., Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 32
• The patient is 3 to 24 months of age with one or more of the following conditions:
1) leukemia, lymphoma, or other cancers
2) bone marrow or peripheral stem transplantation
3) high dose chemotherapy incurring prolonged neutropenia
4) aplastic anemia
• Patient has an absolute neutrophil count <500/mm3 (Note: The patient should have an anticipated duration of neutropenia of =10 days.) AND at least 1 recording of fever >38.0°C (oral or tympanic calibrated to oral) within 72 hours of screening.
Are the trial subjects under 18? yes
Number of subjects for this age range: 9
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Patient is <3 months or >24 months (2 years) of age (at time of drug administration).
• Patient has proven or probable invasive fungal infection at the time of
Enrollment
• Patient is taking systemic antifungal therapy with the exception of prophylactic fluconazole.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method