A multicenter study to increase drug safety concerning the usage of systemic antifungal agents in haematology and oncology

A multicenter study to increase drug safety concerning the usage of systemic antifungal agents in haematology and oncology - MAAMy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00022878

Enrollment

300

Registered

2020-11-13

Start date

2021-04-01

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

C00-C97 B37 B38 B39 B40 B41 B42 B43 B44 B45 B46 B47 B48 B49

Interventions

Group 1: Phase 1 (12 months): Documentaton and evaluation of indication, choice of antifungal agent, dosage, interactions of the antifungal prescriptions WITHOUT advice from a clinical pharmacist Grou

after the end of phase 1): Documentation and evaluation of indication, choice of antifungal agent, dosage, interactions of the antifungal prescriptions WITH advice from a clinical pharmacist

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: age > 18 years, underlying haematological-oncological disease, treatment with systemic antifungal agents

Exclusion criteria

Exclusion criteria: Superficial fungal infection (e.g. nail / skin fungus), inpatient stay <24 h

Design outcomes

Primary

Measure	Time frame
The primary endpoints are the change in the MAI score / patient and the number of existing ABP / patient between the first phase and the second phase.	—

Secondary

Measure	Time frame
- Number of breakthrough infections, postponed chemotherapy, transfers to an intensive care unit and number of deaths due to an invasive fungal infection - Number and severity of side effects typical of antifungal drugs - Time to improvement of symptoms and / or diagnostic parameters (fever, CRP, infiltrates in HR-CT, fungal antigens, etc.) - Serum level measurements of azole antifungal agents phase I vs. Phase II (number of measurements carried out, number of serum levels not in therapeutic range) - The influence of patient-specific factors (demographic and clinical factors, laboratory parameters, concomitant medications) on Serum concentrations of azole antifungals - Number and type of CYP2C19 genotyping carried out - Number of substance changes - Number of implemented recommendations ("response rate") - Satisfaction and acceptance of the measures by the doctors (grading scale)	—

Measure

Time frame

- Number of breakthrough infections, postponed chemotherapy, transfers to an intensive care unit and number of deaths due to an invasive fungal infection - Number and severity of side effects typical of antifungal drugs - Time to improvement of symptoms and / or diagnostic parameters (fever, CRP, infiltrates in HR-CT, fungal antigens, etc.) - Serum level measurements of azole antifungal agents phase I vs. Phase II (number of measurements carried out, number of serum levels not in therapeutic range) - The influence of patient-specific factors (demographic and clinical factors, laboratory parameters, concomitant medications) on Serum concentrations of azole antifungals - Number and type of CYP2C19 genotyping carried out - Number of substance changes - Number of implemented recommendations ("response rate") - Satisfaction and acceptance of the measures by the doctors (grading scale)

—

Countries

Germany

Contacts

Public ContactDorothea Strobach

Promotionsprogramm Klinische Pharmazie und Apotheke, LMU Klinikum München

dorothea.strobach@med.uni-muenchen.de089440076600

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Aug 9, 2026