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Antifungal Drugs in Pulmonary Mucormycosis

ConditionPulmonary Mucormycosis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorBin Cao

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years or older diagnosed with pulmonary mucormycosis (PM).

Individuals with Probable or proved PM, as indicated by clinical and radiological findings.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Combination therapy group

    Drug

    Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

  • Liposomal Amphotericin B

    Drug

    Liposomal amphotericin B (AmBisome®) alone

Treatment groups

312 Participants
are divided into 2 treatment groups
Group A: Single drug groupActive comparator 1 intervention
Group B: Combination therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

4-week favourable response rate

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

Time frame
4 week

Secondary outcomes

1

12-week mortality

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

Time frame
12 week
2

24-week mortality

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

Time frame
24 week
3

Frequency of adverse events

Treatment-related adverse event frequency

Time frame
4 week

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bin Cao

Lead sponsor

Capital Medical University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: