Non-interventional Study on the Safety and Efficacy for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania – ERADICATE Study

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prescription event monitoring, Prospective Phase 4 study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  MICAFUNGIN
• Additional medical condition(s):
  Post-Exposure Prophylaxis

Population studied

• Short description of the study population:
  Paediatric Asia/Oceania patients diagnosed with proven/probable/possible fungal infections, or requiring prophylaxis for fungal infections, whom have been prescribed with MYCAMINE® 2 mg/kg/day, MYCAMINE® 3 mg/kg/day, MYCAMINE® 100mg/day or MYCAMINE® 150mg/day in a routine clinical practice setting.; ; Patients will be enrolled in this study only if they meet all of the following criteria:; 1. Male or female, aged from birth to <18 years.; 2. Prescribed micafungin for prophylaxis or treatment of fungal infections, as determined by treating physician in accordance with the local label.; 3. An Informed Consent form has been signed and dated by parents/ guardians (or legally accepted caregivers), consistent with ICH-GCP guidelines and local legislation. An informed assent suitable for the age group has to be obtained from patients if applicable.
• Age groups:
  • Term newborn infants (0 – 27 days)
  • Infants and toddlers (28 days – 23 months)
  • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  120

Study design details

• Main study objective:
  The aim of the study is to prospectively evaluate the safety and efficacy of micafungin when prescribed for prophylaxis or treatment of fungal infections in different real-world clinical conditions and centers, in pediatric patients in Asia/Oceania.
• Outcomes:
  Incidence and severity of Adverse Drug Reactions (ADRs) collected during the observational period with onset up to 3 days after end of treatment, with onset later than 3 days after end of treatment and overall. Incidence of Serious Adverse Events (SAE) with onset up to 30 days after end of treatment. Incidence of death attributable to micafungin treatment. Incidence of adverse events. Overall treatment success.Change from baseline to end of treatment in safety laboratory parameters indicating hepatic or renal dysfunction.Adverse events regardless of relationship to micafungin treatment.Mycological response at end of treatment in patients with proven invasive fungal infection with candida or aspergillus species.
• Data analysis plan:
  The study has only one treatment arm. All patients will be treated with Micafungin. Descriptive analyses for baseline characteristics, medication intake and efficacy analyses will in general be stratified in accordance with the clinical presentation of the patients at baseline. For efficacy, results will in addition be presented pooled over the categories probable and proven invasive fungal infection. Safety data will be summarized for the total safety analysis set.In general, all data will be summarized with descriptive statistics (number of patients, mean, SD, minimum, median and maximum) for continuous variables, and frequency and percentage of patients for categorical variables. For efficacy, 95% confidence intervals will be provided.