Trial reportAntimicrobial agents and chemotherapy2002
Pharmacokinetics, excretion, and mass balance of liposomal amphotericin B (AmBisome) and amphotericin B deoxycholate in humans.
Trial report in Antimicrobial agents and chemotherapy, 2002. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 117 papers, 3 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
117 citing papers in PubMed, 3 syntheses or guidelines pooled it, 312 citations in OpenAlex.
- Population pharmacokinetics of liposomal amphotericin B in adults with HIV-associated cryptococcal meningoencephalitis.The Journal of antimicrobial chemotherapy · 2022Pooled it
- Population Pharmacokinetic Model and Meta-analysis of Outcomes of Amphotericin B Deoxycholate Use in Adults with Cryptococcal Meningitis.Antimicrobial agents and chemotherapy · 2018Pooled it
- Antifungal pharmacodynamics: Latin America's perspective.The Brazilian journal of infectious diseases : an official publication of the Brazilian Society of Infectious DiseasesPooled it
- Efficacy of Cochleated Amphotericin B in Mouse and Human Mucocutaneous Candidiasis.Antimicrobial agents and chemotherapy · 2022Trial
- Fixed Dosing of Liposomal Amphotericin B in Morbidly Obese Individuals.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2020Trial
- Randomized comparison of liposomal amphotericin B versus placebo to prevent invasive mycoses in acute lymphoblastic leukaemia.The Journal of antimicrobial chemotherapy · 2017Trial
- [Candiduria! What now? : Therapy of urinary tract infections with Candida].Der Urologe. Ausg. A · 2017Trial
- Population pharmacokinetics of conventional and intermittent dosing of liposomal amphotericin B in adults: a first critical step for rational design of innovative regimens.Antimicrobial agents and chemotherapy · 2012Trial
- Population pharmacokinetics of liposomal amphotericin B and caspofungin in allogeneic hematopoietic stem cell recipients.Antimicrobial agents and chemotherapy · 2012Trial
- Randomized comparison of safety and pharmacokinetics of caspofungin, liposomal amphotericin B, and the combination of both in allogeneic hematopoietic stem cell recipients.Antimicrobial agents and chemotherapy · 2010Trial
- Pharmacokinetics and buccal mucosal concentrations of a 15 milligram per kilogram of body weight total dose of liposomal amphotericin B administered as a single dose (15 mg/kg), weekly dose (7.5 mg/kg), or daily dose (1 mg/kg) in peripheral stem cell transplant patients.Antimicrobial agents and chemotherapy · 2009Trial
- Plasma protein distribution and its impact on pharmacokinetics of liposomal amphotericin B in paediatric patients with malignant diseases.European journal of clinical pharmacology · 2007Trial
- High-dose weekly AmBisome antifungal prophylaxis in pediatric patients undergoing hematopoietic stem cell transplantation: a pharmacokinetic study.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2006Trial
- Population pharmacokinetics of amphotericin B lipid complex in neonates.Antimicrobial agents and chemotherapy · 2005Trial
- Plasma protein binding of amphotericin B and pharmacokinetics of bound versus unbound amphotericin B after administration of intravenous liposomal amphotericin B (AmBisome) and amphotericin B deoxycholate.Antimicrobial agents and chemotherapy · 2002Trial
- Beyond Nanosizing: Mechanism-Guided Design and Rational Selection of Polymeric and Lipid Nanocarriers for Translatable Drug Delivery.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2026Review
- Antibiotics and Other Drugs Removal by the CytoSorbAntibiotics (Basel, Switzerland) · 2026Review
- Synergistic Effect of 5-Fluorouracil and Amphotericin B in Murine Paracoccidioidomycosis: Immune Modulation and Enhanced Fungal Clearance.ACS infectious diseases · 2026Article
- Liposomal amphotericin B and renal safety: review of the evidence and clinical considerations.The Journal of antimicrobial chemotherapy · 2026Review
- Successful outpatient parenteral antimicrobial therapy with rezafungin for chronic pulmonary aspergillosis: a case report and health economic assessment.JAC-antimicrobial resistance · 2025Article
57 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The pharmacokinetics, excretion, and mass balance of liposomal amphotericin B (AmBisome) (liposomal AMB) and the conventional formulation, AMB deoxycholate (AMB-DOC), were compared in a phase IV, open-label, parallel study in healthy volunteers. After a single 2-h infusion of 2 mg of liposomal AMB/kg of body weight or 0.6 mg of AMB-DOC/kg, plasma, urine, and feces were collected for 168 h. The concentrations of AMB were determined by liquid chromatography tandem mass spectrometry (plasma, urine, feces) or high-performance liquid chromatography (HPLC) (plasma). Infusion-related side effects similar to those reported in patients, including nausea and back pain, were observed in both groups. Both formulations had triphasic plasma profiles with long terminal half-lives (liposomal AMB, 152 +/- 116 h; AMB-DOC, 127 +/- 30 h), but plasma concentrations were higher (P < 0.01) after administration of liposomal AMB (maximum concentration of drug in serum [C(max)], 22.9 +/- 10 microg/ml) than those of AMB-DOC (Cmax, 1.4 +/- 0.2 microg/ml). Liposomal AMB had a central compartment volume close to that of plasma (50 +/- 19 ml/kg) and a volume of distribution at steady state (Vss) (774 +/- 550 ml/kg) smaller than the Vss of AMB-DOC (1,807 +/- 239 ml/kg) (P < 0.01). Total clearances were similar (approximately 10 ml hr(-1) kg(-1)), but renal and fecal clearances of liposomal AMB were 10-fold lower than those of AMB-DOC (P < 0.01). Two-thirds of the AMB-DOC was excreted unchanged in the urine (20.6%) and feces (42.5%) with >90% accounted for in mass balance calculations at 1 week, suggesting that metabolism plays at most a minor role in AMB elimination. In contrast, <10% of the liposomal AMB was excreted unchanged. No metabolites were observed by HPLC or mass spectrometry. In comparison to AMB-DOC, liposomal AMB produced higher plasma exposures and lower volumes of distribution and markedly decreased the excretion of unchanged drug in urine and feces. Thus, liposomal AMB significantly alters the excretion and mass balance of AMB. The ability of liposomes to sequester drugs in circulating liposomes and within deep tissue compartments may account for these differences.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.