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Not yet recruitingNCT06756191Updated Jan 1, 2025

Antifungal Drugs in Pulmonary Mucormycosis

A Phase 4 interventional study of Combination therapy group and Liposomal Amphotericin B in Pulmonary Mucormycosis, sponsored by Bin Cao. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-01.

Sponsored by Bin Cao · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 4 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
312
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Pulmonary Mucormycosis

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Keywords

  • Pulmonary Mucormycosis
  • Amphotericin B liposome
  • isavuconazole
03

In context

Mucormycosis

32 studies on the registry are indexed under Mucormycosis; 8 are open to participants now.

This study's planned enrollment of 312 is above the median of 82 across 13 interventional studies indexed under Mucormycosis.

Browse Mucormycosis studies →

Lead sponsor

Bin Cao is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 (AST), alanine aminotransferase (ALT), alkaline phosphatase, or levels exceeding five times the (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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
312 participants (estimated)

Study arms

  • Active comparator
    Single drug group

    Liposomal amphotericin B (AmBisome®)

    Drug: Liposomal Amphotericin B

  • Experimental
    Combination therapy

    Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

    Drug: Combination therapy group

Interventions

  • DrugCombination therapy group

    Liposomal amphotericin B (AmBisome®) combination with Isavuconazole

  • Liposomal amphotericin B (AmBisome®) alone

06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06756191
Lead sponsor
Bin Cao
Responsible party
Bin Cao (Professor, Capital Medical University) — Sponsor-investigator
First posted
Jan 1, 2025
Start date
Jan 10, 2025 (estimated)
Primary completion
Jul 10, 2025 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jan 1, 2025

Study contacts

Bin Cao, M.D.
Contact
zhibo_liu1985@163.com
+010086 15210682464
Bin Cao
principal investigator · China-Japan Friendship Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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