Antifungal Drugs in Pulmonary Mucormycosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Combination therapy group, Liposomal Amphotericin B.
- Who it may be relevant to
- Registry conditions: Pulmonary Mucormycosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation on Efficacy and Safety of Liposomal Amphotericin B(AmBisome® ) Combination with Isavuconazole Versus AmBisome® Alone for Treatment of Patients with Pulmonary Mucormycosis
Overview
Pulmonary mucormycosis (PM) poses a substantial clinical challenge, particularly among immunocompromised patients. The aim of the study is to determine the effectiveness and safety of administering AmBisome at a dose of 5mg/kg/day combined with isavuconazole versus using AmBisome for the management of pulmonary mucormycosis
Interventions
- Drug Combination therapy group
Liposomal amphotericin B (AmBisome®) combination with Isavuconazole - Drug Liposomal Amphotericin B
Liposomal amphotericin B (AmBisome®) alone
Primary outcome measures
- 4-week favourable response rate [Time frame: 4 week]
Secondary outcome measures (3)
- 12-week mortality [Time frame: 12 week]
- 24-week mortality [Time frame: 24 week]
- Frequency of adverse events [Time frame: 4 week]
Eligibility criteria
Inclusion criteria
- Patients aged 18 years or older diagnosed with pulmonary mucormycosis (PM).
- Individuals with Probable or proved PM, as indicated by clinical and radiological findings.
Exclusion criteria
- Patients with a history of pulmonary mucormycosis (PM) who have previously been treated with amphotericin B for a duration exceeding 5 days.
- Patients who have documented allergies to azoles or amphotericin B regimens
- Patients with serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, or bilirubin levels exceeding five times the upper limit of normal (ULN).
- Patients with irreversible heart or liver failure, or those experiencing massive, fatal hemoptysis.
- Patients who have experienced a myocardial infarction or cerebral infarction.
- Patients currently receiving extracorporeal membrane oxygenation (ECMO) treatment.
- Pregnant or breastfeeding individuals. 8.Patients with individual reasons that may prevent them from completing the treatment protocol.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06756191 · 2024-KY-413