Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT00842504
Eligibility Criteria:
Inclusion Criteria:
* Hospitalized patients who are at risk for fungal infection and require prophylaxis.
* Age ≤ 10 years excluding neonates
* Children must have an indwelling venous access device
* Patients with adequate organ function (documented within 2 weeks prior to start of micafungin): creatinine \< 2 times upper limit normal; ALT, AST and total bilirubin ≤ 3 times upper limit normal
Exclusion Criteria:
* Patients who are \< 28 days old (neonates) or \> 10 years of age
* Patients who have history of past or evidence of active fungal disease (by either radiological studies or biopsy proven) or are being treated for presumed fungal infection.
* Patients who have history of allergy to micafungin or other echinocandin preparations, such as Caspofungin or Anidulafungin.
* Patients who have received micafungin or other echinocandin preparations in the previous two weeks.
* Patients receiving antifungal prophylaxis other than Fluconazole at the time of enrollment.
* Failure to sign informed consent, or inability to undergo informed consent process.
* Not medically advisable to obtain the specimens necessary.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
29 Days
Maximum Age:
10 Years
Study:
NCT00842504
Study Brief:
Protocol Section:
NCT00842504