A Phase 4 interventional study of Determination of blood drug concentration in Invasive Fungal Infections and Liposomal Amphotericin B, sponsored by Beijing Anzhen Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by Beijing Anzhen Hospital · Phase 4, Interventional, and Treatment
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Among 29 studies in Invasive Fungal Infections with a site in China — 12 open to participants now, 12 under way, none of them phase 3. Invasive Fungal Infections · China.
Among the 29 studies in Invasive Fungal Infections with a site in China, this one is the 10th largest by planned enrollment of the 12 interventional ones that give a count, is one of 7 that started in 2025, is one of 5 in phase 4, reaches primary completion later than 3 of the 11 other live ones, and was the 17th registered.
136 studies on the registry are indexed under Invasive Fungal Infections; 33 are open to participants now.
Browse Invasive Fungal Infections studies →12 of the 29 studies in Invasive Fungal Infections with a site in China are open now. Recruiting first, the newest first:
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Sites in China
Ages 3–17
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 1 mo–18 yrs
Haikou Affiliated Hospital of Central South University Xiangya School of Medicine · Sites in China
Ages 18–75
Institute of Hematology & Blood Diseases Hospital, China · Sites in China
Ages 18+
Peking University People's Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 20 Invasive Fungal Infections studies recruiting now, 12 (60%) set no upper age limit and 5 (25%) stop at 75 or younger; 9 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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29 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 7 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 70 across 67 interventional studies indexed under Invasive Fungal Infections.
Median enrollment 74 across the 12 interventional studies, 120 across the 17 observational. Of the 13 that completed or were terminated, 3 (23%) have results posted.
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9 of 29 have an industry lead sponsor. The 10 most frequent:
Beijing Anzhen Hospital is the lead sponsor of 193 studies on the registry; 103 are open to participants now.
Beijing Anzhen Hospital has 1 study filed under Invasive Fungal Infections — fewer than ten, so there is no comparison to draw.
4 of the studies in Invasive Fungal Infections with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07135778Institute of Hematology & Blood Diseases Hospital, ChinaLiposomal Amphotericin B and Isavuconazole/Posaconazole in Br-IFD（ Breakthrough Invasive Fungal Disease） in Patients With Malignant Hematological Diseases | 2026-12-31 |
| NCT07725263Haikou Affiliated Hospital of Central South University Xiangya School of MedicineLow-Dose Liposomal Amphotericin B for Invasive Fungal Infection Prophylaxis in Neutropenic Children | 2027-02-28 |
| NCT07357038Institute of Hematology & Blood Diseases Hospital, ChinaA Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB(Liposomal Amphotericin B) for br- IFD(Breakthrough Invasive Fungal Disease) in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis | 2027-02-28 |
| NCT07763184Nanfang Hospital, Southern Medical UniversitymNGS for IFD in Patients With Hematological Malignancies | 2027-09-30 |
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Among the 29 studies in Invasive Fungal Infections with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The goal of this study is to investigate the effects of ECMO-assisted therapy on L-AmB PK parameters in patients with critically ill patients of invasive fungal infections, and to determine the in vivo pharmacokinetic changes of L-AmB in the ECMO population. To establish and validate a population pharmacokinetic model for liposomal amphotericin B in patients with critically ill patients of invasive fungal infections treated with ECMO adjuvant therapy, and to explore the pharmacokinetics/pharmacodynamics of the drug with different dosing regimens.
The information of patient characteristics, physiological parameters, ECMO related parameters, administration and sampling information of L-AmB were collected.Patients were intravenously titrated after 3 doses of maintenance dose titration. The sampling window was from 0 to 24 h. The time points were 0.5 h before and 1, 2, 3, 6, 9, 12, 16, 20 and 24 h after administration. NONMEM software was applied to establish the PPK model of L-AmB.
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Exclusion Criteria:
To establish and validate a population pharmacokinetic model for L-AmB in patients with severe invasive fungal infections treated undergoing ECMO-assisted therapy.
Biological: Determination of blood drug concentration
Collecting blood samples from patients and determining blood drug concentrations. Patients were intravenously titrated after 3 doses of maintenance dose titration of L-AmB. The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration. Then, the blood concentrations were determined according to the established method.
Blood drug concentration of liposomal amphotericin B
Patients were intravenously titrated after 3 doses of maintenance dose titration of L-AmB. Then collecting blood samples from these patients. The blood concentrations of L-AmB were determined according to the established method.
Time frame: The time points of sample collecting were 30 minutes before and 1, 2, 3, 6, 9, 12, 16, 20, 24 hours after administration.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2025; primary completion for Nov 2025, 10 months later.
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