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Article: Amphotericin B nephrotoxicity in children.

Goldman, Ran D / Koren, Gideon

Journal of pediatric hematology/oncology

2004 Volume 26, Issue 7, Page(s) 421–426

Abstract: ... risk factors. Mechanisms to prevent nephrotoxicity include the use of lipid formulations such as amphotericin B ... the most clinically significant adverse effect, but studies examining nephrotoxicity in children are scarce ... Amphotericin B is the treatment of choice for severe systemic fungal infections. Nephrotoxicity is ...

Abstract	Amphotericin B is the treatment of choice for severe systemic fungal infections. Nephrotoxicity is the most clinically significant adverse effect, but studies examining nephrotoxicity in children are scarce. Nephrotoxicity includes decreased glomerular filtration rate and distal tubulopathy with urinary loss of potassium and magnesium, renal tubular acidosis, loss of urine concentrating ability, and sometimes Fanconi's syndrome. The mechanisms involved in nephrotoxicity include the use of deoxycholate, the vehicle for amphotericin, reduction in renal blood flow and glomerular filtration rate, increased salt concentrations at the macula densa, interaction of amphotericin with ergosterol in the cell membrane, and apoptosis in proximal tubular cells and medullary interstitial cells. Some risk factors for amphotericin nephrotoxicity have been determined over the years. Cumulative dosage, treatment duration, and dosing schedule as well as the combination of amphotericin with other nephrotoxic drugs, such as diuretics and cyclosporine, are important risk factors. Mechanisms to prevent nephrotoxicity include the use of lipid formulations such as amphotericin B lipid complex, amphotericin B colloidal dispersion, and liposomal amphotericin B and the concurrent use of volume repletion. Amiloride can be considered in serious potassium loss.
MeSH term(s)	Adult ; Amphotericin B/adverse effects ; Amphotericin B/pharmacokinetics ; Animals ; Antifungal Agents/adverse effects ; Antifungal Agents/pharmacokinetics ; Child ; Humans ; Kidney Diseases/chemically induced ; Kidney Diseases/prevention & control ; Risk Factors
Chemical Substances	Antifungal Agents ; Amphotericin B (7XU7A7DROE)
Language	English
Publishing date	2004-08-25
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Review
ZDB-ID	1231152-2
ISSN	1536-3678 ; 1077-4114 ; 0192-8562
ISSN (online)	1536-3678
ISSN	1077-4114 ; 0192-8562
DOI	10.1097/00043426-200407000-00004
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Zs.A 1537: Show issues

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Article: Pharmacological risk factors for amphotericin B nephrotoxicity in children.

Goldman, Ran D / Ong, Michael / Wolpin, Jacob / Doyle, John / Parshuram, Christopher / Koren, Gideon

Journal of clinical pharmacology

2007 Volume 47, Issue 8, Page(s) 1049–1054

MeSH term(s)	Adolescent ; Amphotericin B/adverse effects ; Antifungal Agents/adverse effects ; Child ; Child, Preschool ; Creatinine/blood ; Female ; Humans ; Infant ; Infant, Newborn ; Kidney Diseases/chemically induced ; Kidney Diseases/epidemiology ; Male ; Retrospective Studies ; Risk Factors
Chemical Substances	Antifungal Agents ; Amphotericin B (7XU7A7DROE) ; Creatinine (AYI8EX34EU)
Language	English
Publishing date	2007-08
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	188980-1
ISSN	1552-4604 ; 0091-2700 ; 0021-9754
ISSN (online)	1552-4604
ISSN	0091-2700 ; 0021-9754
DOI	10.1177/0091270007301799
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Uf I Zs.176: Show issues

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Article ; Online: Therapeutic drug monitoring of liposomal amphotericin B in children. Are we there yet? A systematic review.

Lai, Tony / Yeo, Chin-Yen / Rockliff, Bradley / Stokes, Michael / Kim, Hannah Yejin / Marais, Ben J / McLachlan, Andrew J / Alffenaar, Jan-Willem C

The Journal of antimicrobial chemotherapy

2024 Volume 79, Issue 4, Page(s) 703–711

Abstract: ... but its role for liposomal amphotericin B (L-amb) is unclear. This systematic review assessed the evidence ... for L-amb TDM in children.: Objectives: To evaluate the concentration-efficacy relationship ... concentration-toxicity relationship and pharmacokinetic/pharmacodynamic (PK/PD) variability of L-amb in children ...

Abstract	Introduction: Therapeutic drug monitoring (TDM) is a tool that supports personalized dosing, but its role for liposomal amphotericin B (L-amb) is unclear. This systematic review assessed the evidence for L-amb TDM in children. Objectives: To evaluate the concentration-efficacy relationship, concentration-toxicity relationship and pharmacokinetic/pharmacodynamic (PK/PD) variability of L-amb in children. Methods: We systematically reviewed PubMed and Embase databases following PRISMA guidelines. Eligible studies included L-amb PK/PD studies in children aged 0-18 years. Review articles, case series of <five patients, editorials and animal studies were excluded. Quality assessment was performed using the Critical Appraisal of Clinical Pharmacokinetics tool. The concentration-efficacy and concentration-toxicity relationships and PK/PD variability were analysed.<br />Results: In total, 4220 studies were screened; 6 were included, presenting data on 195 children. Invasive candidiasis and aspergillosis were the two most common infections treated with L-amb. Studies showed significant PK variability due to age (mean age ranged from 14 days to 17 years), body weight, non-linear PK and changes in the volume of distribution. Limited evidence supported a peak concentration/MIC (Cmax/MIC) of 25-50 for optimal efficacy and an AUC24 of >600 mg·h/L for nephrotoxicity. L-amb doses of 2.5-10 mg/kg/day were reported to achieve Cmax/MIC > 25 using an MIC of 1 mg/L. Conclusions: While significant PK variability was observed in children, evidence to support routine L-amb TDM was limited. Further studies on efficacy and toxicity benefits are required before routine TDM of L-amb can be recommended.
MeSH term(s)	Child ; Animals ; Humans ; Infant, Newborn ; Antifungal Agents/adverse effects ; Drug Monitoring ; Amphotericin B/adverse effects ; Candidiasis, Invasive/drug therapy
Chemical Substances	liposomal amphotericin B ; Antifungal Agents ; Amphotericin B (7XU7A7DROE)
Language	English
Publishing date	2024-01-22
Publishing country	England
Document type	Systematic Review ; Journal Article
ZDB-ID	191709-2
ISSN	1460-2091 ; 0305-7453
ISSN (online)	1460-2091
ISSN	0305-7453
DOI	10.1093/jac/dkae003
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Zs.A 1197: Show issues			Location: Je nach Verfügbarkeit (siehe Angabe bei Bestand) bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular Jg. 1995 - 2021: Lesesall (1.OG) ab Jg. 2022: Lesesaal (EG)
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Article ; Online: Evaluation of renal effects of liposomal amphotericin B in children with malignancies with KDIGO and RIFLE criteria.

Devrim, Fatma / Çağlar, İlknur / Acar, Sultan Okur / Akkuş, Şeyma / Dinçel, Nida / Yılmaz, Ebru / Tahta, Neryal / Demirağ, Bengü / Karapınar, Tuba Hilkay / Gözmen, Salih / Oymak, Yeşim / Vergin, Canan / Bayram, Nuri / Devrim, İlker

Nephrologie & therapeutique

2021 Volume 17, Issue 7, Page(s) 507–511

Abstract: ... the nephrotoxicity associated with L-AmB in children with acute lymphoblastic leukemia and acute myeloid leukemia ... of the treatment for medically important opportunistic fungal pathogens in children. This study aimed to compare ... Background: Amphotericin B is a broad-spectrum antifungal agent and is the backbone ...

Abstract	Background: Amphotericin B is a broad-spectrum antifungal agent and is the backbone of the treatment for medically important opportunistic fungal pathogens in children. This study aimed to compare the nephrotoxicity associated with L-AmB in children with acute lymphoblastic leukemia and acute myeloid leukemia. Materials and methods: A total of 112 pediatric acute lymphoblastic leukemia or acute myeloid leukemia patients who received treatment with L-AmB (Ambisome®) at the University of Health Sciences Dr Behcet Uz Children's Hospital over 7 years were included. The incidence of hypokalemia, decreased estimated glomerular filtration rate and presence of acute kidney injury was recorded. Results: The average L-AmB treatment duration was 17.1±15.0 days. Five patients (4.4%) of the patients had grade I acute renal injury according to KDIGO criteria and 16 patients (14.2%) had increased risk for kidney injury according to RIFLE criteria. There were no patients with eGFR decrease above 50% and no renal injury and failure were observed during L-AmB treatment. The rate of patients with hypokalemia in the pre-treatment was 17.9% and the post-L-AmB group was 50.0%. The rate of hypokalemia was higher in the post-treatment group (P=0.0015). Among the 112 patients, only two patients (1.7%) required cessation of L-AmB treatment due to resistant hypokalemia despite supplementation. Conclusions: Hypokalemia was more common compared to glomerulotoxicity and acute renal injury (according to KDIGO and RIFLE criteria) in pediatric leukemia patients treated with L-AmB. Hypokalemia developed in nearly half of the patients and the study shows the need for randomized controlled trials and strategies for hypokalemia associated with L-AmB treatment.
MeSH term(s)	Acute Kidney Injury/chemically induced ; Acute Kidney Injury/epidemiology ; Amphotericin B/adverse effects ; Child ; Humans ; Kidney ; Neoplasms ; Retrospective Studies
Chemical Substances	liposomal amphotericin B ; Amphotericin B (7XU7A7DROE)
Language	English
Publishing date	2021-09-15
Publishing country	France
Document type	Journal Article
ZDB-ID	2229575-6
ISSN	1872-9177 ; 1769-7255
ISSN (online)	1872-9177
ISSN	1769-7255
DOI	10.1016/j.nephro.2021.06.007
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Zs.A 6298: Show issues

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Article ; Online: Amphotericin B deoxycholate versus liposomal amphotericin B: effects on kidney function.

Botero Aguirre, Juan Pablo / Restrepo Hamid, Alejandra Maria

The Cochrane database of systematic reviews

2015 , Issue 11, Page(s) CD010481

Abstract: ... amphotericin B is less nephrotoxic than conventional amphotericin B (when the effect on kidney function is ... of several factors. Conventional amphotericin B (sodium deoxycholate) has been used as standard therapy ... acute kidney injury (AKI). New formulations of amphotericin B have aimed to improve the safety profile ...

Abstract	Background: The incidence of invasive fungal infections has increased globally as a result of several factors. Conventional amphotericin B (sodium deoxycholate) has been used as standard therapy for the treatment of invasive fungal infections; however, it is associated with adverse drug reactions, including acute kidney injury (AKI). New formulations of amphotericin B have aimed to improve the safety profile of the conventional formulation. Objectives: This review aimed to assess the effects of amphotericin B deoxycholate versus liposomal amphotericin B on kidney function. Search methods: We searched Cochrane Kidney and Transplant's Specialised Register to 10 March 2015 through contact with the Trials' Search Co-ordinator using search terms relevant to this review. Selection criteria: We included randomised controlled trials (RCTs) that compared amphotericin B sodium deoxycholate with liposomal amphotericin B. Data collection and analysis: Two authors independently assessed studies for eligibility and conducted risk of bias evaluation. Main results: We included 12 studies (2298 participants) in this review. Of these, 10 were meta-analysed (2172 participants). Liposomal amphotericin B was found to be significantly safer than conventional amphotericin B in terms of serum creatinine increase (RR 0.49, 95% CI 0.40 to 0.59). There was significant decrease in all infusion-related reactions in the liposomal group compared with the conventional group: fever (4 studies, 1092 participants): RR 0.39, 95% CI 0.28 to 0.55; I(2) = 32%); chills and/or rigours (5 studies, 1081 participants): RR 0.27, 95% CI 0.15 to 0.48; I(2) = 75%); fever and/or rigours (2 studies, 720 participants): RR 0.68, 95% CI 0.52 to 0.90; I(2) = 58%); nausea (6 studies, 1187 participants): RR 0.50, 95% CI 0.35 to 0.72; I(2) = 0%); and vomiting (3 studies, 1019 participants): RR 0.51, 95% CI 0.27 to 0.95; I(2) = 61%). Overall, risk of bias in included studies was low or unclear for most domains. However, blinding of participants and personnel, blinding of outcome assessment and other bias (funding) tended to have a high risk of bias. The sensitivity analysis performed did not change the significance of difference in favour of the liposomal formulation. Assessment for publication bias found that review results were robust. Authors' conclusions: Current evidence suggests that liposomal amphotericin B is less nephrotoxic than conventional amphotericin B (when the effect on kidney function is measured as an increase in serum creatinine level equal to or greater than two-fold from the baseline level). We also found that there were fewer infusion-related reactions associated with the liposomal formulation.
MeSH term(s)	Adult ; Amphotericin B/adverse effects ; Amphotericin B/therapeutic use ; Antifungal Agents/adverse effects ; Antifungal Agents/therapeutic use ; Child ; Chills/chemically induced ; Creatinine/blood ; Deoxycholic Acid/adverse effects ; Deoxycholic Acid/therapeutic use ; Drug Combinations ; Female ; Fever/chemically induced ; Humans ; Kidney/drug effects ; Male ; Nausea/chemically induced ; Randomized Controlled Trials as Topic ; Vomiting/chemically induced
Chemical Substances	Antifungal Agents ; Drug Combinations ; liposomal amphotericin B ; Deoxycholic Acid (005990WHZZ) ; Amphotericin B (7XU7A7DROE) ; amphotericin B, deoxycholate drug combination (87687-70-5) ; Creatinine (AYI8EX34EU)
Language	English
Publishing date	2015-11-23
Publishing country	England
Document type	Journal Article ; Meta-Analysis ; Research Support, Non-U.S. Gov't ; Review ; Systematic Review
ISSN	1469-493X
ISSN (online)	1469-493X
DOI	10.1002/14651858.CD010481.pub2
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Article ; Online: Deoxycholate amphotericin B and nephrotoxicity in the pediatric setting.

Bes, David F / Rosanova, María T / Sberna, Norma / Arrizurieta, Elvira

The Pediatric infectious disease journal

2014 Volume 33, Issue 8, Page(s) e198–206

Abstract: ... dosing regimens designed to decrease nephrotoxicity. Conventional amphotericin B, with appropriate kidney ... from comparative studies in children evaluating the nephrotoxicity risks of the 4 agents are controversial ... efficacy and fewer nephrotoxic effects in adults than conventional amphotericin B, but the conclusions ...

Abstract	Since the introduction of amphotericin B as an antifungal agent, the morbidity and mortality of pediatric patients with mycotic infections have increased, primarily because of the increased immunocompromised patients. Despite the fact that deoxycholate amphotericin B was once the primary drug used for mycotic infections, its administration to children older than neonates is currently controversial because of its nephrotoxic effects. Three lipid-associated formulations have been developed and have reportedly shown similar efficacy and fewer nephrotoxic effects in adults than conventional amphotericin B, but the conclusions from comparative studies in children evaluating the nephrotoxicity risks of the 4 agents are controversial. Nevertheless, guidelines favor liposomal or lipid complex amphotericin B when polyene antifungal therapy is recommended in this age group. However, high acquisition costs often preclude their prescription in economically poor regions. Thus, physicians must consider all of these factors when determining the most cost-effective polyene antifungal treatment for their pediatric patients. This is particularly pertinent in developing countries where resources are scarce. Adjuvant sodium supplementation has been reported to be effective in protecting kidney function in extremely low birth weight infants prescribed deoxycholate amphotericin B. Further pharmacokinetic and pharmacodynamic studies of the drug in children could also provide information for rational dosing regimens designed to decrease nephrotoxicity. Conventional amphotericin B, with appropriate kidney protective measures, still plays a role in the treatment of empiric invasive mycotic infections in most pediatric patients. Liposomal and lipid complex amphotericin B should be reserved for those receiving long-term nephrotoxic agents or with altered renal function or disease. Antifungal susceptibility, renal compromise and the clinical status of the patient should determine treatment for culture-proven infections. Under the current cost limitations, undertaking and evaluating low-cost, kidney-sparing, deoxycholate amphotericin B treatments for children should be a primary concern.
MeSH term(s)	Adolescent ; Amphotericin B/administration & dosage ; Amphotericin B/adverse effects ; Antifungal Agents/administration & dosage ; Antifungal Agents/adverse effects ; Child ; Child, Preschool ; Deoxycholic Acid/administration & dosage ; Deoxycholic Acid/adverse effects ; Drug Combinations ; Humans ; Infant ; Infant, Newborn ; Kidney Diseases/chemically induced ; Mycoses/drug therapy
Chemical Substances	Antifungal Agents ; Drug Combinations ; Deoxycholic Acid (005990WHZZ) ; Amphotericin B (7XU7A7DROE) ; amphotericin B, deoxycholate drug combination (87687-70-5)
Language	English
Publishing date	2014-08
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	392481-6
ISSN	1532-0987 ; 0891-3668
ISSN (online)	1532-0987
ISSN	0891-3668
DOI	10.1097/INF.0000000000000299
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Zs.A 1852: Show issues

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Article ; Online: Adverse effects of amphotericin B in children; a retrospective comparison of conventional and liposomal formulations.

Andrew, Eden C / Curtis, Nigel / Coghlan, Ben / Cranswick, Noel / Gwee, Amanda

British journal of clinical pharmacology

2018 Volume 84, Issue 5, Page(s) 1006–1012

Abstract: ... effects associated with standard doses of c-amB and liposomal amphotericin (l-amB) in children.: Methods ... from medical records to compare amphotericin-related infusion reactions, nephrotoxicity (glomerulotoxicity and ... Aims: Lipid formulations of amphotericin B, rather than conventional amphotericin (c-amB), are ...

Abstract	Aims: Lipid formulations of amphotericin B, rather than conventional amphotericin (c-amB), are increasingly used despite limited data comparing these preparations in children. Data on the incidence of adverse effects with amphotericin B at standard doses are scarce. This study aimed to compare the adverse effects associated with standard doses of c-amB and liposomal amphotericin (l-amB) in children. Methods: Children admitted to the Royal Children's Hospital Melbourne and treated with c-amB or l-amB between January 2010 and September 2013 were included. Clinical and laboratory data were retrospectively extracted from medical records to compare amphotericin-related infusion reactions, nephrotoxicity (glomerulotoxicity and tubulopathy) and hepatotoxicity. Results: Seventy-six children received c-amB and 39 received l-amB. Standard drug administration (recommended dose and infusion time) occurred in 74% (56/76) of patients on c-amB and 85% (33/39) on l-amB. In these 89 children, infusion-related reactions were similar for both c-amB and l-amB (23% (13/56) vs. 9% (3/33); P = 0.15); none occurred in children aged <90 days. There was no difference in amphotericin-associated glomerulotoxicity (c-amB 14% (8/56) vs. l-amB 21% (7/33); P = 0.40) or in the median maximum potassium requirements (c-amB 3.1 vs. l-amB 2.3 mmol kg Conclusions: When appropriately administered, l-amB was associated with more hepatotoxicity than c-amB, with no difference in infusion-related reactions or nephrotoxicity. Differences in adverse effects between the preparations is not as marked in children as reported in adults.
MeSH term(s)	Adolescent ; Amphotericin B/adverse effects ; Antifungal Agents/adverse effects ; Australia ; Chemical and Drug Induced Liver Injury ; Child ; Child, Preschool ; Drug Hypersensitivity ; Female ; Humans ; Infant ; Infant, Newborn ; Kidney Diseases/chemically induced ; Male ; Retrospective Studies ; Young Adult
Chemical Substances	Antifungal Agents ; liposomal amphotericin B ; Amphotericin B (7XU7A7DROE)
Language	English
Publishing date	2018-03-01
Publishing country	England
Document type	Comparative Study ; Journal Article
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.13521
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Zs.A 1118: Show issues

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Article ; Online: Liposomal amphotericin B in critically ill paediatric patients.

Sideri, G / Falagas, M E / Grigoriou, M / Vouloumanou, E K / Papadatos, J H / Lebessi, E / Kafetzis, D A

Journal of clinical pharmacy and therapeutics

2012 Volume 37, Issue 3, Page(s) 291–295

Abstract: ... In 16 of the 23 included children, liposomal amphotericin B was administered for the treatment ... What is known and objective: Literature provides much evidence regarding liposomal amphotericin B ... patients of older age are scarce. We aimed to present our experience regarding liposomal amphotericin B use ...

Abstract	What is known and objective: Literature provides much evidence regarding liposomal amphotericin B treatment for fungal infections in neonates and infants. Relevant data regarding critically ill paediatric patients of older age are scarce. We aimed to present our experience regarding liposomal amphotericin B use in critically ill paediatric patients from a tertiary-care paediatric hospital in Athens, Greece. Methods: We prospectively identified all paediatric patients who received treatment with liposomal amphotericin B in the intensive care unit of a tertiary-care paediatric hospital during a 3-year period (2005-2008). Data were retrieved from the evaluation of the available medical records. Results and discussion: Twenty-three (nine females, mean age: 26·4 months, range: 5-39 months) critically ill paediatric patients were included; 12 had malignancy. In 16 of the 23 included children, liposomal amphotericin B was administered for the treatment of confirmed fungal infections (all but one were invasive), whereas in seven patients, it was used as pre-emptive treatment. One patient received voriconazole concomitantly. Eleven of the 16 children with documented infections were cured; five improved. Six of the seven children who received pre-emptive treatment also showed clinical improvement. Nine deaths were noted, all attributed to underlying diseases. Two cases of hepatotoxicity and one case of nephrotoxicity (all leading to drug-discontinuation) occurred. Seven and five cases of mild reversible hypokalaemia and hyponatraemia, respectively, were also noted. What is new and conclusion: According to the findings of our small case series, liposomal amphotericin B may provide a useful treatment option for fungal infections of vulnerable critically ill paediatric patients with considerable comorbidity.
MeSH term(s)	Amphotericin B/administration & dosage ; Amphotericin B/adverse effects ; Amphotericin B/therapeutic use ; Antifungal Agents/administration & dosage ; Antifungal Agents/adverse effects ; Antifungal Agents/therapeutic use ; Chemical and Drug Induced Liver Injury/etiology ; Child, Preschool ; Comorbidity ; Drug Monitoring ; Female ; Greece/epidemiology ; Hospitals, Pediatric ; Humans ; Hypokalemia/chemically induced ; Hyponatremia/chemically induced ; Infant ; Intensive Care Units, Pediatric ; Liposomes ; Male ; Mycoses/blood ; Mycoses/drug therapy ; Mycoses/epidemiology ; Mycoses/prevention & control ; Neoplasms/epidemiology ; Prospective Studies ; Renal Insufficiency/chemically induced
Chemical Substances	Antifungal Agents ; Liposomes ; Amphotericin B (7XU7A7DROE)
Language	English
Publishing date	2012-06
Publishing country	England
Document type	Journal Article
ZDB-ID	639006-7
ISSN	1365-2710 ; 0269-4727
ISSN (online)	1365-2710
ISSN	0269-4727
DOI	10.1111/j.1365-2710.2011.01288.x
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Zs.A 1313: Show issues

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Article ; Online: To evaluate efficacy and safety of amphotericin B in two different doses in the treatment of post kala-azar dermal leishmaniasis (PKDL).

Rabi Das, Vidya Nand / Siddiqui, Niyamat Ali / Pal, Biplab / Lal, Chandra Shekhar / Verma, Neena / Kumar, Ashish / Verma, Rakesh Bihari / Kumar, Dhirendra / Das, Pradeep / Pandey, Krishna

PloS one

2017 Volume 12, Issue 3, Page(s) e0174497

Abstract: ... A and group B respectively. Two patients each from either group relapsed. Nephrotoxicity was the most ... and safety of amphotericin B in two different doses (0.5mg/kg vs 1mg/kg) in a prospective randomized ... 60 years were randomized in two groups. Group A received amphotericin B in the dose of 0.5 mg/kg in 5 ...

Abstract	Background: Post kala-azar dermal leishmaniasis (PKDL) is a skin disorder that usually occurs among patients with a past history of visceral leishmaniasis (VL). Cases are also reported without a history of VL. There is no satisfactory treatment regimen available at present. We aimed to compare the efficacy and safety of amphotericin B in two different doses (0.5mg/kg vs 1mg/kg) in a prospective randomized trial in 50 PKDL patients. Methods: In this open label study 50 patients with PKDL, aged between 5-60 years were randomized in two groups. Group A received amphotericin B in the dose of 0.5 mg/kg in 5% dextrose, daily for 20 infusions for 3 courses at an interval of 15 days between each course and Group B received amphotericin B in the dose of 1mg/kg in 5% dextrose on alternate days, 20 infusions for 3 courses an interval of 15 days between each course and followed up for one year. Results: A total of 50 patients were enrolled, 25 in each of group A and group B. Two patients lost to follow up and three patients withdrew consent due to adverse events. The initial cure rate was 92% in group A and 88% in group B by intention to treat analysis and final cure rate by per protocol analysis was 95.65% and 95.45% in group A and group B respectively. Two patients each from either group relapsed. Nephrotoxicity was the most common adverse event occurring in both the groups. Conclusion: The lower dose appears to have fewer adverse events however, nephrotoxicity remains a problem in both regimens. The 0.5mg/kg regimen may be considered instead of the higher dosage however safer treatments remain critical for PKDL treatment.
MeSH term(s)	Adolescent ; Adult ; Amphotericin B/administration & dosage ; Amphotericin B/adverse effects ; Antiprotozoal Agents/administration & dosage ; Antiprotozoal Agents/adverse effects ; Child ; Dose-Response Relationship, Drug ; Female ; Humans ; Leishmania/drug effects ; Leishmaniasis, Cutaneous/drug therapy ; Leishmaniasis, Cutaneous/parasitology ; Leishmaniasis, Visceral/parasitology ; Leishmaniasis, Visceral/pathology ; Male ; Parasite Load ; Renal Insufficiency/chemically induced ; Treatment Outcome ; Young Adult
Chemical Substances	Antiprotozoal Agents ; Amphotericin B (7XU7A7DROE)
Language	English
Publishing date	2017
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial
ISSN	1932-6203
ISSN (online)	1932-6203
DOI	10.1371/journal.pone.0174497
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Article ; Online: Efficacy and Safety of Liposomal Amphotericin B for Visceral Leishmaniasis in Children and Adolescents at a Tertiary Care Center in Bihar, India.

Pandey, Krishna / Pal, Biplab / Siddiqui, Niyamat Ali / Rabi Das, Vidya Nand / Murti, Krishna / Lal, Chandra Shekhar / Verma, Neena / Babu, Rajendra / Ali, Vahab / Kumar, Rakesh / Das, Pradeep

The American journal of tropical medicine and hygiene

2017 Volume 97, Issue 5, Page(s) 1498–1502

Abstract: ... that liposomal amphotericin B at 10 mg/kg body weight is safe and effective in children. Results of our study ... Liposomal amphotericin B is being used increasingly to reduce the burden of kala-azar ... We, therefore, felt it was important to reassess the efficacy and safety of single dose liposomal amphotericin B ...

Abstract	Liposomal amphotericin B is being used increasingly to reduce the burden of kala-azar from the Indian subcontinent. There are studies which have evaluated efficacy and safety of liposomal amphotericin B for visceral leishmaniasis in all age groups. However, the only study that specifically addressed treatment of childhood visceral leishmaniasis did not include all ages or document renal and liver function. We, therefore, felt it was important to reassess the efficacy and safety of single dose liposomal amphotericin B in children and adolescents. A total of 100 parasitologically confirmed visceral leishmaniasis patients aged < 15 years were included in this study. Participants consisted of 65 males and 35 females. All of them had come from the endemic region of Bihar. They were administered one dose intravenous infusion of liposomal amphptericin B at 10 mg/kg body weight. Efficacy was assessed as initial and final cure at 1 and 6 months, respectively, and safety of all participants who were recruited in the study. The initial and final cure rate by per protocol analysis was 100% and 97.9%, respectively. Chills and rigors were the most commonly occurring adverse events (AEs). All the AEs were mild in intensity, and none of the patients experienced any serious AEs. No patients developed nephrotoxicity. Our finding indicates that liposomal amphotericin B at 10 mg/kg body weight is safe and effective in children. Results of our study support the use of single dose liposomal amphotericin B in all age group populations for elimination of kala-azar from the Indian subcontinent.
MeSH term(s)	Adolescent ; Amphotericin B/therapeutic use ; Antiprotozoal Agents/therapeutic use ; Child ; Dose-Response Relationship, Drug ; Female ; Follow-Up Studies ; Humans ; India ; Infusions, Intravenous ; Leishmaniasis, Visceral/drug therapy ; Male ; Prospective Studies ; Tertiary Care Centers
Chemical Substances	Antiprotozoal Agents ; liposomal amphotericin B ; Amphotericin B (7XU7A7DROE)
Language	English
Publishing date	2017-10-10
Publishing country	United States
Document type	Journal Article
ZDB-ID	2942-7
ISSN	1476-1645 ; 0002-9637
ISSN (online)	1476-1645
ISSN	0002-9637
DOI	10.4269/ajtmh.17-0094
Database	MEDical Literature Analysis and Retrieval System OnLINE

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