Invasive Fungal InfectionLAMB-SOTNCT07656493
Liposomal Amphotericin B for Invasive Fungal Disease in Solid Organ Transplant Recipients
An observational study of Invasive Fungal Infection and Solid Organ Transplantation, run by Sichuan Provincial People's Hospital at 1 site in China.
Trial summary
This real-world observational study aims to evaluate the effectiveness, safety, and therapeutic drug monitoring (TDM) of liposomal amphotericin B (L-AmB) in solid organ transplant recipients with invasive fungal disease (IFD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Fungal Infection, Solid Organ Transplantation, Opportunistic Infections
- What is being tested?
- Liposomal Amphotericin B and Alternative Systemic Antifungal Therapy
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Jun 2028
- Phase
- Observational
- 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
Study population: Adult solid organ transplant recipients diagnosed with proven, probable, or possible invasive fungal disease and treated with liposomal amphotericin B or alternative systemic antifungal therapy at Sichuan Provincial People's Hospital.
Who may be able to join
- Age 18 to 75 years.
- Recipient of a solid organ transplant.
- Diagnosis of invasive fungal disease (IFD) according to EORTC/MSGERC criteria.
- Receiving liposomal amphotericin B therapy as part of routine clinical care.
- Provision of informed consent for prospective participants.
Who cannot join
- Known hypersensitivity to amphotericin B formulations.
- Severe hepatic dysfunction (ALT or AST >5× upper limit of normal, or total bilirubin >2× upper limit of normal).
- Severe renal dysfunction requiring permanent discontinuation of antifungal therapy at baseline.
- Pregnancy or breastfeeding.
- Participation judged inappropriate by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Lingai Pan, MD, +86 17708130236, panlingai2004@163.com
About this study
Official title: A Real-World Observational Study of the Effectiveness, Safety, and Therapeutic Drug Monitoring of Liposomal Amphotericin B in Solid Organ Transplant Recipients With Invasive Fungal Disease
This real-world observational study aims to evaluate the effectiveness, safety, and therapeutic drug monitoring (TDM) of liposomal amphotericin B (L-AmB) in solid organ transplant recipients with invasive fungal disease (IFD). IFD is a major cause of morbidity and mortality in transplant recipients because of long-term immunosuppressive therapy and increased susceptibility to opportunistic fungal infections.
This is a single-center ambispective cohort study conducted at Sichuan Provincial People's Hospital. The study includes a prospective cohort of solid organ transplant recipients receiving L-AmB therapy and a historical control cohort treated with alternative systemic antifungal regimens. Clinical management and treatment decisions will be determined by treating physicians according to routine clinical practice, and no study-specific intervention will be introduced.
Read more
The study will collect information on demographic characteristics, transplant type, immunosuppressive regimens, fungal pathogens, infection sites, antifungal treatment strategies, laboratory findings, and clinical outcomes. Particular attention will be given to renal safety, electrolyte abnormalities, and therapeutic drug monitoring of liposomal amphotericin B. Plasma concentrations of L-AmB, treatment modifications, temporary treatment discontinuation, and concentration-related safety and effectiveness outcomes will be recorded during antifungal therapy.
The primary outcomes are the 28-day clinical response rate and 84-day all-cause mortality. Secondary outcomes include mycological clearance, acute kidney injury, electrolyte abnormalities, breakthrough fungal infection, treatment discontinuation due to adverse events, liposomal amphotericin B plasma concentrations, and the associations between L-AmB exposure and clinical outcomes or treatment-related toxicities.
The study is expected to provide real-world evidence regarding the effectiveness, safety, and pharmacokinetic characteristics of L-AmB in transplant recipients, support optimization of antifungal treatment strategies, and inform individualized dosing and monitoring approaches in this high-risk population.
- Being tested
- Liposomal Amphotericin B, Alternative Systemic Antifungal Therapy
- Keywords
- Liposomal Amphotericin B, Solid Organ Transplantation, Invasive Fungal Disease, Antifungal Therapy, Tacrolimus, Cyclosporine, Therapeutic Drug Monitoring, Drug-Drug Interaction, Real-World Study, Transplant Infection
- Medical subject headings
- Invasive Fungal Infections, Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Amphotericin BDrug
Also called L-AmB
Liposomal amphotericin B administered for treatment of proven, probable, or possible invasive fungal disease in solid organ transplant recipients according to routine clinical practice. Dose adjustment and treatment duration are determined by treating physicians.
Alternative Systemic Antifungal TherapyDrug
Also called Azoles, Echinocandins
Alternative systemic antifungal agents including azoles, echinocandins, or other standard antifungal therapies administered according to routine clinical practice in historical control patients with invasive fungal disease.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Amphotericin B Cohort | Solid organ transplant recipients with invasive fungal disease receiving liposomal amphotericin B therapy. Receives: Drug: Liposomal Amphotericin B | |
| Historical Control Cohort | Historical control patients with invasive fungal disease treated with alternative systemic antifungal regimens. Receives: Drug: Alternative Systemic Antifungal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-Day Clinical Response Rate
Proportion of participants achieving complete or partial clinical response at Day 28 after initiation of antifungal therapy.
Measured: Day 28
84-Day All-Cause Mortality
All-cause mortality occurring within 84 days after initiation of antifungal therapy.
Measured: Day 84
Secondary outcomes (8)
Mycological Clearance Rate
Proportion of participants with documented clearance of fungal pathogens.
Measured: Day 28
Acute Kidney Injury
Occurrence of acute kidney injury during antifungal treatment.
Measured: Baseline through Day 84
Electrolyte Abnormalities
Occurrence of hypokalemia, hypomagnesemia, or other treatment-related electrolyte disturbances.
Measured: Baseline through Day 84
Liposomal Amphotericin B Plasma Concentration
Plasma concentration of liposomal amphotericin B measured during antifungal therapy.
Measured: Baseline through Day 84
Association Between Liposomal Amphotericin B Exposure and Clinical Response
Relationship between liposomal amphotericin B plasma concentration and clinical response.
Measured: Baseline through Day 84
Association Between Liposomal Amphotericin B Exposure and Adverse Events
Relationship between liposomal amphotericin B plasma concentration and treatment-related adverse events, including nephrotoxicity and electrolyte abnormalities.
Measured: Baseline through Day 84
Breakthrough Fungal Infection
Occurrence of breakthrough invasive fungal infection during antifungal therapy.
Measured: Baseline through Day 84
Antifungal Treatment Discontinuation Due to Adverse Events
Permanent discontinuation of antifungal therapy because of treatment-related adverse events.
Measured: Baseline through Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive Fungal InfectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Science and Technology Innovation Medical Development Foundation
- Responsible party
- Principal investigator, Lingai Pan, Sichuan Provincial People's Hospital
- Investigators
- Lingai Pan, MD, Principal investigator, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656493
- Sponsor's protocol ID
- KC2025-JX-0390WLH-06
- Other IDs
- KC2025-JX-0390WLH-06
- Acronym
- LAMB-SOT
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to patient confidentiality and institutional data protection requirements.
Publications
Donnelly JP, Chen SC, Kauffman CA, Steinbach WJ, Baddley JW, Verweij PE, Clancy CJ, Wingard JR, Lockhart SR, Groll AH, Sorrell TC, Bassetti M, Akan H, Alexander BD, Andes D, Azoulay E, Bialek R, Bradsher RW, Bretagne S, Calandra T, Caliendo AM, Castagnola E, Cruciani M, Cuenca-Estrella M, Decker CF, Desai SR, Fisher B, Harrison T, Heussel CP, Jensen HE, Kibbler CC, Kontoyiannis DP, Kullberg BJ, Lagrou K, Lamoth F, Lehrnbecher T, Loeffler J, Lortholary O, Maertens J, Marchetti O, Marr KA, Masur H, Meis JF, Morrisey CO, Nucci M, Ostrosky-Zeichner L, Pagano L, Patterson TF, Perfect JR, Racil Z, Roilides E, Ruhnke M, Prokop CS, Shoham S, Slavin MA, Stevens DA, Thompson GR, Vazquez JA, Viscoli C, Walsh TJ, Warris A, Wheat LJ, White PL, Zaoutis TE, Pappas PG. Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium. Clin Infect Dis. 2020 Sep 12;71(6):1367-1376. doi: 10.1093/cid/ciz1008.
PubMed 31802125
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Observational Study of the Effectiveness, Safety, and Therapeutic Drug Monitoring of Liposomal Amphotericin B in Solid Organ Transplant Recipients With Invasive Fungal Disease
- ClinicalTrials.gov ID
- NCT07656493
- Acronym / sponsor ID
- LAMB-SOT / KC2025-JX-0390WLH-06
- Keywords
- Liposomal Amphotericin B, Solid Organ Transplantation, Invasive Fungal Disease, Antifungal Therapy, Tacrolimus, Cyclosporine, Therapeutic Drug Monitoring, Drug-Drug Interaction
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sichuan Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Science and Technology Innovation Medical Development Foundation
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 18 Jun 2026 (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.
This real-world observational study aims to evaluate the effectiveness, safety, and therapeutic drug monitoring (TDM) of liposomal amphotericin B (L-AmB) in solid organ transplant recipients with invasive fungal disease (IFD). IFD is a major cause of morbidity and mortality in transplant recipients because of long-term immunosuppressive therapy and increased susceptibility to opportunistic fungal infections.
This is a single-center ambispective cohort study conducted at Sichuan Provincial People's Hospital. The study includes a prospective cohort of solid organ transplant recipients receiving L-AmB therapy and a historical control cohort treated with alternative systemic antifungal regimens. Clinical management and treatment decisions will be determined by treating physicians according to routine clinical practice, and no study-specific intervention will be introduced.
The study will collect information on demographic characteristics, transplant type, immunosuppressive regimens, fungal pathogens, infection sites, antifungal treatment strategies, laboratory findings, and clinical outcomes. Particular attention will be given to renal safety, electrolyte abnormalities, and therapeutic drug monitoring of liposomal amphotericin B. Plasma concentrations of L-AmB, treatment modifications, temporary treatment discontinuation, and concentration-related safety and effectiveness outcomes will be recorded during antifungal therapy.
The primary outcomes are the 28-day clinical response rate and 84-day all-cause mortality. Secondary outcomes include mycological clearance, acute kidney injury, electrolyte abnormalities, breakthrough fungal infection, treatment discontinuation due to adverse events, liposomal amphotericin B plasma concentrations, and the associations between L-AmB exposure and clinical outcomes or treatment-related toxicities.
The study is expected to provide real-world evidence regarding the effectiveness, safety, and pharmacokinetic characteristics of L-AmB in transplant recipients, support optimization of antifungal treatment strategies, and inform individualized dosing and monitoring approaches in this high-risk population.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Amphotericin B Cohort | – | Drug: Liposomal Amphotericin BSolid organ transplant recipients with invasive fungal disease receiving liposomal amphotericin B therapy. |
| Historical Control Cohort | – | Drug: Alternative Systemic Antifungal TherapyHistorical control patients with invasive fungal disease treated with alternative systemic antifungal regimens. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult solid organ transplant recipients diagnosed with proven, probable, or possible invasive fungal disease and treated with liposomal amphotericin B or alternative systemic antifungal therapy at Sichuan Provincial People's Hospital.
Key inclusion criteria (5 listed)
- Age 18 to 75 years.
- Recipient of a solid organ transplant.
- Diagnosis of invasive fungal disease (IFD) according to EORTC/MSGERC criteria.
- Receiving liposomal amphotericin B therapy as part of routine clinical care.
- Provision of informed consent for prospective participants.
Key exclusion criteria (5 listed)
- Known hypersensitivity to amphotericin B formulations.
- Severe hepatic dysfunction (ALT or AST >5× upper limit of normal, or total bilirubin >2× upper limit of normal).
- Severe renal dysfunction requiring permanent discontinuation of antifungal therapy at baseline.
- Pregnancy or breastfeeding.
- Participation judged inappropriate by the investigator.
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 |
|---|---|---|
| Liposomal Amphotericin BAlso: L-AmBLiposomal amphotericin B administered for treatment of proven, probable, or possible invasive fungal disease in solid organ transplant recipients according to routine clinical practice. Dose adjustment and treatment duration are determined by treating physicians. | Drug | Liposomal Amphotericin B Cohort |
| Alternative Systemic Antifungal TherapyAlso: Azoles, EchinocandinsAlternative systemic antifungal agents including azoles, echinocandins, or other standard antifungal therapies administered according to routine clinical practice in historical control patients with invasive fungal disease. | Drug | Historical Control Cohort |
Primary outcome
28-Day Clinical Response Rate
Time frame: Day 28
Proportion of participants achieving complete or partial clinical response at Day 28 after initiation of antifungal therapy.
84-Day All-Cause Mortality
Time frame: Day 84
All-cause mortality occurring within 84 days after initiation of antifungal therapy.
8 secondary outcomes
Mycological Clearance Rate
Time frame: Day 28
Acute Kidney Injury
Time frame: Baseline through Day 84
Electrolyte Abnormalities
Time frame: Baseline through Day 84
Liposomal Amphotericin B Plasma Concentration
Time frame: Baseline through Day 84
Association Between Liposomal Amphotericin B Exposure and Clinical Response
Time frame: Baseline through Day 84
Association Between Liposomal Amphotericin B Exposure and Adverse Events
Time frame: Baseline through Day 84
Breakthrough Fungal Infection
Time frame: Baseline through Day 84
Antifungal Treatment Discontinuation Due to Adverse Events
Time frame: Baseline through Day 84
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 24 Jun 2026.
- Background: PubMed 31802125Donnelly JP, Chen SC, Kauffman CA, Steinbach WJ, Baddley JW, Verweij PE, Clancy CJ, Wingard JR, Lockhart SR, Groll AH, Sorrell TC, Bassetti M, Akan H, Alexander BD, Andes D, Azoulay E, Bialek R, Bradsher RW, Bretagne S, Calandra T, Caliendo AM, Castagnola E, Cruciani M, Cuenca-Estrella M, Decker CF, Desai SR, Fisher B, Harrison T, Heussel CP, Jensen HE, Kibbler CC, Kontoyiannis DP, Kullberg BJ, Lagrou K, Lamoth F, Lehrnbecher T, Loeffler J, Lortholary O, Maertens J, Marchetti O, Marr KA, Masur H, Meis JF, Morrisey CO, Nucci M, Ostrosky-Zeichner L, Pagano L, Patterson TF, Perfect JR, Racil Z, Roilides E, Ruhnke M, Prokop CS, Shoham S, Slavin MA, Stevens DA, Thompson GR, Vazquez JA, Viscoli C, Walsh TJ, Warris A, Wheat LJ, White PL, Zaoutis TE, Pappas PG. Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium. Clin Infect Dis. 2020 Sep 12;71(6):1367-1376. doi: 10.1093/cid/ciz1008.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to patient confidentiality and institutional data protection requirements.
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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.
Lingai Pan, MD principal investigator
Sichuan Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Fungal Infection and Solid Organ Transplantation, run by Sichuan Provincial People's Hospital at 1 site in China.
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 5 inclusion and 5 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 24 Jun 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 China. 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.
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 Lingai Pan, MD (+86 17708130236, panlingai2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-Day Clinical Response Rate (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07656493, which also lists 1 linked publication.
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 24 Jun 2026.