Clinical trial NCT05116059: To Evaluate the Efficacy and Safety of ABCD in the Treatment of IFD
Official title: To Evaluate the Efficacy and Safety of Amphotericin B Colloidal Dispersion (ABCD) in the Treatment of Invasive Fungal Disease: a Multicenter, Retrospective, Observational, Non-interventional Registration Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Fungal Disease
Keywords: Amphotericin B Colloidal Dispersion
Invasive fungal disease
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with invasive fungal disease and accepted of ABCD

Brief summary: In order to better guide clinical medication, verify the efficacy and safety of ABCD in the treatment of various invasive fungal disease, the investigators have designed a multi-center, retrospective registration study. Diagnosis and treatment data for patients with different types of invasive fungal disease in clinical actual environment was collapsed by a database for collaborative exchange on antifungal research.

Detailed description: This study is a retrospective, non-interventional, and observational study. The clinical data of the patient during hospitalization shall be collected at least 2 weeks after the end of the ABCD drug, including basic data of the patient, laboratory data and clinical treatment, mainly covering antifungal medications, such as pretreatment measures, drug dosage and dispensing method, route of administration, duration of administration, efficacy and adverse reactions, etc. If adverse events related to ABCD have not ended after 2 weeks, investigators are advised to follow up until the adverse events recover or stabilize. It is hoped that the basic situation of Chinese invasive fungal patients is described, and ABCD is evaluated in the treatment of invasive fungal patients. In addition, prognostic factors can be analyzed to optimize clinical medication regimen and provide basis support for clinical medication of ABCD.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years.
2. Patients with possible/probable/proven invasive fungal disease according to EORTC-MSG diagnostic criteria.
3. Patients received ABCD alone or in combination with other antifungals on either empirical, diagnosis-driven or targeted therapy.
4. There is no limit to the patient's previous treatment plan.

Exclusion Criteria:

1. Patients judged by clinicians to be unsuitable for this study.
2. Patients with incomplete data or other factors affecting the judgment of efficacy and safety.

Primary outcomes:
measure: therapeutic response rate
timeFrame: within one week of the last administration of ABCD
measure: Infusion reaction, renal toxicity, hypokalemia, liver function and other adverse events [Safety and Tolerability]
timeFrame: from the date of start medication until the date of last dose of ABCD. If the adverse reaction has not ended after 2 weeks, clinicians are advised to follow up until the adverse event has recovered or stabilized (Assessed up to 1 week).
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: zhengyin Liu, PhD
role: STUDY_CHAIR
References: