Mucormycosis; Pulmonary (Etiology)Phase 2NCT05468372
Amphotericin Versus Posaconazole for Pulmonary Mucormycosis
A Phase 2 study testing Posaconazole 600 mg followed by posaconazole 300 mg once daily and Liposomal Amphotericin B in people with Mucormycosis; Pulmonary (Etiology), run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Pulmonary mucormycosis is a serious illness with high morbidity and mortality (approximately 57%). Surgery and antifungal therapy are central in the management of mucormycosis. Unlike rhino-orbital mucormycosis, surgery is not feasible in several patients with pulmonary mucormycosis. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Mucormycosis; Pulmonary (Etiology)
- What is being tested?
- Posaconazole 600 mg followed by posaconazole 300 mg once daily and Liposomal Amphotericin B
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2022to 1 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with proven or probable pulmonary mucormycosis. Participants with a suspicion of pulmonary mucormycosis (as defined previously) based on compatible clinical presentation and compatible imaging will be screened for inclusion in the study.
Who cannot join
- Failure to provide informed consent
- Contraindications or hypersensitivity to amphotericin B, posaconazole or their components
- Already received >4 days of antifungals prior to randomization into the study
- Pregnant women
- High chances of mortality within 48 hours of enrolment into the study
- Subjects with possible pulmonary mucormycosis will also be excluded, if their diagnosis is not confirmed within four working days of enrollment
Trial locations and contacts
1 site in 1 country.
India1 site
Postgraduate Institute of Medical Education and Research
Chandigarh, Chandigarh, 160012
About this study
Official title: A Randomized Controlled Trial of Amphotericin B Versus Posaconazole for Treating Pulmonary Mucormycosis
Pulmonary mucormycosis is a serious illness with high morbidity and mortality (approximately 57%). Surgery and antifungal therapy are central in the management of mucormycosis. Unlike rhino-orbital mucormycosis, surgery is not feasible in several patients with pulmonary mucormycosis. Hence, treatment is primarily with antifungal therapy. Amphotericin B is the standard of care in the medical management of mucormycosis. However, amphotericin B is expensive, has significant adverse events, and is available only in parenteral formulation. Posaconazole is effective against Mucorales, and is currently approved for salvage therapy of mucormycosis. Recent evidence suggest that in several patients, posaconazole may be effective as a monotherapy upfront. In the current study posaconazole versus amphotericin B will be evaluated for the management of pulmonary mucormycosis in a randomized clinical trial.
- Conditions
- Mucormycosis; Pulmonary (Etiology)
- Being tested
- Posaconazole 600 mg followed by posaconazole 300 mg once daily, Liposomal Amphotericin B
- Keywords
- fungal pneumonia,, zygomycosis, invasive mold disease, Mucorales, Posaconazole
- Medical subject headings
- Mucormycosis, Zygomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posaconazole 600 mg followed by posaconazole 300 mg once dailyDrug
Also called In the experimental arm, the first seven days of posaconazole will be overlapped with liposomal amphotericin B 5 mg/kg body weight intravenous infusion (similar to the active comparator arm)
Posaconazole will be given as a delayed release tablet, the dose would be 600 mg in two divided doses on day 1, followed by 300 mg once a day from then on. If a subject vomits within 15 minutes of posaconazole tablet administration, the dosing should be repeated as soon as possible, following appropriate antiemetic treatment. The drug will be administered after a meal.
Liposomal Amphotericin BDrug
Also called LAMB
All study subjects will be administered intravenous liposomal amphotericin B [5 mg/kg/day infusion in 5% dextrose solution] over at least 2 hours, as per recommendations. Amphotericin B will be administered for the first seven days in the experimental arm, whereas it will be administered atleast for four weeks in the active comparator arm. Premedication or intravenous hydration will not be routinely administered. For patients experiencing chills, fever, hypotension, nausea, or other non-anaphylactic immediate infusion-related reactions, premedication (acetaminophen, diphenhyramine or hydrocortisone) will be administered 30 to 60 minutes prior to the next dose of amphotericin infusion.
The dose of intravenous amphotericin B will be modified further if required, based on the tolerability, and response to treatment.
| Study group | Role | What they receive |
|---|---|---|
| Amphotericin B arm (standard of care) | Active comparator | Intravenous liposomal amphotericin B [5 mg/kg per day] for at least 4 weeks followed by maintenance therapy. Maintenance therapy (after four weeks of treatment initiation) will be continued for at least 12 weeks or longer as decided by the treating physician. The maintenance therapy will be posaconazole. However, if therapeutic drug monitoring is not possible or the participants opt to use isavuconazole or amphotericin, the same will be permitted and noted Receives: Drug: Liposomal Amphotericin B |
| Posaconazole arm | Experimental | Combination of liposomal amphotericin B (5 mg/kg per day) and posaconazole for first 7 days followed by oral posaconazole only (for induction as well as maintenance therapy). The first four weeks of therapy will be called induction therapy Receives: Drug: Posaconazole 600 mg followed by posaconazole 300 mg once daily; Drug: Liposomal Amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants achieving a successful outcome (complete response or partial response) at the completion of six weeks. The response assessment will be a composite of clinical and radiological as adjudged by a multidisciplinary team
Overall response based on clinical assessment at six weeks after randomization as described recently in a Delphi consensus statement and previous studies on invasive mold infection of the lung. (PMID: 35390293) Based on clinical and radiological response (assessed on CT scan using the two-dimensional measurement of the largest target lesion [WHO criteria, like in lung cancer response assessment]). The overall response will be classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or death. CR or PR will be labeled success, while SD, PD or death will be labeled as failure
Measured: six weeks after randomization
Secondary outcomes (3)
The proportion of participants achieving a successful outcome (complete response or partial response) at the completion of twelve weeks. The response assessment will be a composite of clinical and radiological as adjudged by a multidisciplinary team
Overall response based on clinical assessment at twelve weeks after randomization as described recently in a Delphi consensus statement and previous studies on invasive mold infection of the lung. (PMID: 35390293) Based on clinical and radiological response (assessed on CT scan using the two-dimensional measurement of the largest target lesion [WHO criteria, like in lung cancer response assessment]). The overall response will be classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or death. CR or PR will be labeled success, while SD, PD or death will be labeled as failure
Measured: telve weeks after randomization
90-day mortality
Survival at 90 days will be assessed either by in-person or telephonic follow-up
Measured: 90 days after randomization
Adverse events related to therapy and the number of participants needing either discontinuation or modification of drug therapy due to adverse events
Adverse events to liposomal amphotericin B and posaconazole including deranged liver and renal functions will be assessed
Measured: First four weeks of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Jul 2022
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucormycosis; Pulmonary (Etiology)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ritesh Agarwal, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468372
- Sponsor's protocol ID
- IEC-INT/2022/DM-262
- Status last verified
- Sep 2024
- First submitted
- 16 Jul 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Amphotericin B Versus Posaconazole for Treating Pulmonary Mucormycosis
- ClinicalTrials.gov ID
- NCT05468372
- Acronym / sponsor ID
- IEC-INT/2022/DM-262
- Conditions
- Mucormycosis; Pulmonary (Etiology)
- Keywords
- fungal pneumonia,, zygomycosis, invasive mold disease, Mucorales, Posaconazole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 21 Jul 2022 (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 is a serious illness with high morbidity and mortality (approximately 57%). Surgery and antifungal therapy are central in the management of mucormycosis. Unlike rhino-orbital mucormycosis, surgery is not feasible in several patients with pulmonary mucormycosis. Hence, treatment is primarily with antifungal therapy. Amphotericin B is the standard of care in the medical management of mucormycosis. However, amphotericin B is expensive, has significant adverse events, and is available only in parenteral formulation. Posaconazole is effective against Mucorales, and is currently approved for salvage therapy of mucormycosis. Recent evidence suggest that in several patients, posaconazole may be effective as a monotherapy upfront. In the current study posaconazole versus amphotericin B will be evaluated for the management of pulmonary mucormycosis in a randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amphotericin B arm (standard of care) | Active comparator | Drug: Liposomal Amphotericin BIntravenous liposomal amphotericin B [5 mg/kg per day] for at least 4 weeks followed by maintenance therapy. Maintenance therapy (after four weeks of treatment initiation) will be continued for at least 12 weeks or longer as decided by the treating physician. The maintenance therapy will be posaconazole. However, if therapeutic drug monitoring is not possible or the participants opt to use isavuconazole or amphotericin, the same will be permitted and noted |
| Posaconazole arm | Experimental | Drug: Posaconazole 600 mg followed by posaconazole 300 mg once daily, Drug: Liposomal Amphotericin BCombination of liposomal amphotericin B (5 mg/kg per day) and posaconazole for first 7 days followed by oral posaconazole only (for induction as well as maintenance therapy). The first four weeks of therapy will be called induction therapy |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with proven or probable pulmonary mucormycosis. Participants with a suspicion of pulmonary mucormycosis (as defined previously) based on compatible clinical presentation and compatible imaging will be screened for inclusion in the study.
Key exclusion criteria (6 listed)
- Failure to provide informed consent
- Contraindications or hypersensitivity to amphotericin B, posaconazole or their components
- Already received >4 days of antifungals prior to randomization into the study
- Pregnant women
- High chances of mortality within 48 hours of enrolment into the study
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 |
|---|---|---|
| Posaconazole 600 mg followed by posaconazole 300 mg once dailyAlso: In the experimental arm, the first seven days of posaconazole will be overlapped with liposomal amphotericin B 5 mg/kg body weight intravenous infusion (similar to the active comparator arm)Posaconazole will be given as a delayed release tablet, the dose would be 600 mg in two divided doses on day 1, followed by 300 mg once a day from then on. If a subject vomits within 15 minutes of posaconazole tablet administration, the dosing should be repeated as soon as possible, following appropriate antiemetic treatment. The drug will be administered after a meal. | Drug | Posaconazole arm |
| Liposomal Amphotericin BAlso: LAMBAll study subjects will be administered intravenous liposomal amphotericin B [5 mg/kg/day infusion in 5% dextrose solution] over at least 2 hours, as per recommendations. Amphotericin B will be administered for the first seven days in the experimental arm, whereas it will be administered atleast for four weeks in the active comparator arm. Premedication or intravenous hydration will not be routinely administered. For patients experiencing chills, fever, hypotension, nausea, or other non-anaphylactic immediate infusion-related reactions, premedication (acetaminophen, diphenhyramine or hydrocortisone) will be administered 30 to 60 minutes prior to the next dose of amphotericin infusion. The dose of intravenous amphotericin B will be modified further if required, based on the tolerability, and response to treatment. | Drug | Amphotericin B arm (standard of care), Posaconazole arm |
Primary outcome
The proportion of participants achieving a successful outcome (complete response or partial response) at the completion of six weeks. The response assessment will be a composite of clinical and radiological as adjudged by a multidisciplinary team
Time frame: six weeks after randomization
Overall response based on clinical assessment at six weeks after randomization as described recently in a Delphi consensus statement and previous studies on invasive mold infection of the lung. (PMID: 35390293) Based on clinical and radiological response (assessed on CT scan using the two-dimensional measurement of the largest target lesion [WHO criteria, like in lung cancer response assessment]). The overall response will be classified as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or death. CR or PR will be labeled success, while SD, PD or death will be labeled as failure
3 secondary outcomes
The proportion of participants achieving a successful outcome (complete response or partial response) at the completion of twelve weeks. The response assessment will be a composite of clinical and radiological as adjudged by a multidisciplinary team
Time frame: telve weeks after randomization
90-day mortality
Time frame: 90 days after randomization
Adverse events related to therapy and the number of participants needing either discontinuation or modification of drug therapy due to adverse events
Time frame: First four weeks of randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Posaconazole 600 mg followed by posaconazole 300 mg once daily and Liposomal Amphotericin B in people with Mucormycosis; Pulmonary (Etiology), run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 1 inclusion and 6 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants achieving a successful outcome (complete response or partial response) at the completion of six weeks. The response assessment will be a composite of clinical and radiological as adjudged by a multidisciplinary team (time frame: six weeks after randomization). 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 22 May 2026.