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A Real-World Study on the Efficacy and Safety of Isavuconazole in the Treatment of Invasive Mold Disease in Children

A Real-World Study on the Efficacy and Safety of Isavuconazole in the Treatment of Invasive Mold Disease in Children

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600129250
Enrollment
Unknown
Registered
2026-08-01
Start date
2026-08-01
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

Invasive Mold Disease

Interventions

Sponsors

Beijing Childrens Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.aged 1 to 18 years; 2.Admitted to the PICU and diagnosed with IMD according to the diagnostic criteria (proven/probable/possible); 3.Planned to receive isavuconazole antifungal therapy (including intravenous or oral formulations); 4.Informed consent has been obtained from the legally authorized representative(s);

Exclusion criteria

Exclusion criteria: 1.IMD has been definitively ruled out; 2.Occurrence of severe drug-related adverse events; 3.Clinical deterioration related to IMD; 4.Presence of any condition that, in the investigator's opinion, makes the use of isavuconazole inappropriate;

Design outcomes

Primary

MeasureTime frame
Mortality rate at hospital discharge;

Secondary

MeasureTime frame
Treatment response rate at 60 days post-discharge;Treatment response rate at hospital discharge;Treatment response rate at 30 days post-discharge;30-day post-discharge mortality rate;Drug-related adverse event rate;

Countries

China

Contacts

Public ContactQuan Wang

Beijing Childrens Hospital,Capital Medical University

wq_bch@163.com+86 10 59616767

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026