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NCT Number: NCT06756191

Antifungal Drugs in Pulmonary Mucormycosis

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

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Key information

Conditions

Pulmonary Mucormycosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Combination therapy group

Drug

Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

Liposomal Amphotericin B

Drug

Liposomal amphotericin B (AmBisome®) alone

Primary outcomes

  1. 4-week favourable response rate

    Time frame: 4 week

    The percentage of patients with favourable response by 4 week. Favourable response is defined as lesion absorption in chest CT.

Secondary outcomes

  1. 12-week mortality

    Time frame: 12 week

    Defined as the proportion of patients who died by 12 week.

  2. 24-week mortality

    Time frame: 24 week

    Defined as the proportion of patients who died by week 24.

  3. Frequency of adverse events

    Time frame: 4 week

    Treatment-related adverse event frequency

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Cao, M.D.

CONTACT

[email protected]

+010086 15210682464

Sponsors and collaborators

Lead sponsor

Bin Cao

Other

Registry information

Official study title

Evaluation on Efficacy and Safety of Liposomal Amphotericin B(AmBisome® ) Combination with Isavuconazole Versus AmBisome® Alone for Treatment of Patients with Pulmonary Mucormycosis

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jan 1, 2025
Registry last updated
Jan 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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