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

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 - the MIFI-study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON43162

Enrollment

120

Registered

2017-01-03

Start date

2017-02-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe fungal infections

Interventions

mycobiome

fungal

infection

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

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

Exclusion criteria: * Age > 19 years, * Lack of informed consent for study participation * Previous proven fungal infection, or treatment for fungal infections

Design outcomes

Primary

Measure	Time frame
* Endpoints EORTC criteria for Invasive Fungal Iinfections (proven, probable, possible) based on standard fungal cultures, galactomannan, CT-chest abnormalities. * Evaluated determinants age, diagnosis, WBC, fever. * Faecal mycobiome (* Aim 1. To evaluate the determinants and the frequency of fungal infections in a prospective cohort of children with cancer. * Aim 2. The validation of an innovative molecular diagnostic method (Fungitect) for the detection and identification of fungal pathogens, risk factors and resistance factors as a basis for rational, patient-adapted, preemptive therapy and monitoring of treatment response. * Aim 3. To analyse the independent predictive value of the mycobiome at diagnosis for development of invasive fungal infections.)	—

Measure

Time frame

* Endpoints EORTC criteria for Invasive Fungal Iinfections (proven, probable, possible) based on standard fungal cultures, galactomannan, CT-chest abnormalities. * Evaluated determinants age, diagnosis, WBC, fever. * Faecal mycobiome (* Aim 1. To evaluate the determinants and the frequency of fungal infections in a prospective cohort of children with cancer. * Aim 2. The validation of an innovative molecular diagnostic method (Fungitect) for the detection and identification of fungal pathogens, risk factors and resistance factors as a basis for rational, patient-adapted, preemptive therapy and monitoring of treatment response. * Aim 3. To analyse the independent predictive value of the mycobiome at diagnosis for development of invasive fungal infections.)

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Secondary

Measure	Time frame
To study, in a clinical setting, the feasibility of the use of molecular, immunological, enzymatic diagnostic tools for a) early identification of invasive fungal infections b) rapid identification of fungal species c) resistance reassessment of existing fungal species under therapy d) monitoring of treatment response Other study parameters (if applicable) * Clinical factors in relation to fungal infections * Correlation between standard fungal diagnostic testing (EORTC criteria) and molecular testing (sensitivity and specificity) * Mycobioma at diagnosis and every 3 weeks	—

Measure

Time frame

To study, in a clinical setting, the feasibility of the use of molecular, immunological, enzymatic diagnostic tools for a) early identification of invasive fungal infections b) rapid identification of fungal species c) resistance reassessment of existing fungal species under therapy d) monitoring of treatment response Other study parameters (if applicable) * Clinical factors in relation to fungal infections * Correlation between standard fungal diagnostic testing (EORTC criteria) and molecular testing (sensitivity and specificity) * Mycobioma at diagnosis and every 3 weeks

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)