Pulmonary MucormycosisPhase 4NCT06756191
Antifungal Drugs in Pulmonary Mucormycosis
A Phase 4 study testing Combination therapy group and Liposomal Amphotericin B in people with Pulmonary Mucormycosis, run by Bin Cao.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Mucormycosis
- What is being tested?
- Combination therapy group and Liposomal Amphotericin B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2025to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older diagnosed with pulmonary mucormycosis (PM).
- Individuals with Probable or proved PM, as indicated by clinical and radiological findings.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Conditions
- Pulmonary Mucormycosis
- Being tested
- Combination therapy group, Liposomal Amphotericin B
- Keywords
- Pulmonary Mucormycosis, Amphotericin B liposome, isavuconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapy groupDrug
Liposomal amphotericin B (AmBisome®) combination with Isavuconazole
Liposomal Amphotericin BDrug
Liposomal amphotericin B (AmBisome®) alone
| Study group | Role | What they receive |
|---|---|---|
| Single drug group | Active comparator | Liposomal amphotericin B (AmBisome®) Receives: Drug: Liposomal Amphotericin B |
| Combination therapy | Experimental | Liposomal amphotericin B (AmBisome®) combination with Isavuconazole Receives: Drug: Combination therapy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 week
Secondary outcomes (3)
12-week mortality
Defined as the proportion of patients who died by 12 week.
Measured: 12 week
24-week mortality
Defined as the proportion of patients who died by week 24.
Measured: 24 week
Frequency of adverse events
Treatment-related adverse event frequency
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start10 Jan 2025 (estimated)
- Primary completion10 Jul 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary MucormycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 312 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bin Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bin Cao, Capital Medical University
- Investigators
- Bin Cao, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756191
- Sponsor's protocol ID
- 2024-KY-413
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06756191
- Acronym / sponsor ID
- 2024-KY-413
- Conditions
- Pulmonary Mucormycosis
- Keywords
- Pulmonary Mucormycosis, Amphotericin B liposome, isavuconazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 312 participants (estimated)
- Lead sponsor
- Bin CaoUniversity, hospital or other
- Study start
- 10 Jan 2025 (estimated)
- Primary completion
- 10 Jul 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single drug group | Active comparator | Drug: Liposomal Amphotericin BLiposomal amphotericin B (AmBisome®) |
| Combination therapy | Experimental | Drug: Combination therapy groupLiposomal amphotericin B (AmBisome®) combination with Isavuconazole |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years or older diagnosed with pulmonary mucormycosis (PM).
- Individuals with Probable or proved PM, as indicated by clinical and radiological findings.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination therapy groupLiposomal amphotericin B (AmBisome®) combination with Isavuconazole | Drug | Combination therapy |
| Liposomal Amphotericin BLiposomal amphotericin B (AmBisome®) alone | Drug | Single drug group |
Primary outcome
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.
3 secondary outcomes
12-week mortality
Time frame: 12 week
24-week mortality
Time frame: 24 week
Frequency of adverse events
Time frame: 4 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- Individual participant dataSharing planned: Yes
Related trials for Pulmonary Mucormycosis
RecruitingObservational study
Chest CT Scan in Pulmonary Mucormycosis: Prognostic Value
Pulmonary Mucormycosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bin Cao principal investigator
China-Japan Friendship Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combination therapy group and Liposomal Amphotericin B in people with Pulmonary Mucormycosis, run by Bin Cao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Cao, M.D. (+010086 15210682464, zhibo_liu1985@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-week favourable response rate (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2025.