The search for frequency, determinants, the predictive value of mycobioma and the role of innovative diagnostics in Invasive Fungal Infections in pediatric oncology patients, the MIFI-study
Completed
- Conditions
- severe fungal infections10017528
- Registration Number
- NL-OMON43162
- Lead Sponsor
- Prinses Máxima Centrum voor Kinderoncologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
* Age *18 years
* Children with cancer and periodic chemotherapy related neutropenia, at high risk for invasive fungal infections, without fungal infection, or without fungal therapy, last 3 months
* Written informed consent
* Port-à-cath / central line in situ
Exclusion Criteria
* Age > 19 years,
* Lack of informed consent for study participation
* Previous proven fungal infection, or treatment for fungal infections < 3 months
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Endpoints EORTC criteria for Invasive Fungal Iinfections (proven, probable,<br /><br>possible) based on standard fungal cultures, galactomannan, CT-chest<br /><br>abnormalities.<br /><br>* Evaluated determinants age, diagnosis, WBC, fever.<br /><br>* Faecal mycobiome<br /><br><br /><br>(* Aim 1. To evaluate the determinants and the frequency of fungal infections<br /><br>in a prospective cohort of children with cancer.<br /><br>* Aim 2. The validation of an innovative molecular diagnostic method<br /><br>(Fungitect) for the detection and identification of fungal pathogens, risk<br /><br>factors and resistance factors as a basis for rational, patient-adapted,<br /><br>preemptive therapy and monitoring of treatment response.<br /><br>* Aim 3. To analyse the independent predictive value of the mycobiome at<br /><br>diagnosis for development of invasive fungal infections.)</p><br>
- Secondary Outcome Measures
Name Time Method <p>To study, in a clinical setting, the feasibility of the use of molecular,<br /><br>immunological, enzymatic diagnostic tools for<br /><br>a) early identification of invasive fungal infections<br /><br>b) rapid identification of fungal species<br /><br>c) resistance reassessment of existing fungal species under therapy<br /><br>d) monitoring of treatment response<br /><br><br /><br>Other study parameters (if applicable)<br /><br>* Clinical factors in relation to fungal infections<br /><br>* Correlation between standard fungal diagnostic testing (EORTC criteria) and<br /><br>molecular testing (sensitivity and specificity)<br /><br>* Mycobioma at diagnosis and every 3 weeks</p><br>