Evidence map›Paper›PMID 22585212›Full record

Trial reportAntimicrobial agents and chemotherapy2012

Optimal dosing of miltefosine in children and adults with visceral leishmaniasis.

Thomas P C Dorlo, Alwin D R Huitema, Jos H Beijnen, Peter J de Vries

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
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  7. Natural Resistance ofThe American journal of tropical medicine and hygiene · 2019
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  13. Article
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  17. Cutaneous leishmaniasis in Afghanistan.Transactions of the Royal Society of Tropical Medicine and Hygiene · 2025
    Review
  18. Labeling Pediatric Products: BPCA Efforts and Orphan Drug Opportunities.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Thomas P C DorloDivision of Infectious Diseases, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands. thomasdorlo@gmail.com
Alwin D R Huitema
Jos H Beijnen
Peter J de Vries

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Only anecdotal data are available on the pharmacokinetics (PK) of miltefosine in children suffering from visceral leishmaniasis (VL). While failure rates were higher in children with VL, steady-state concentrations appeared lower than those seen with adults. We hypothesized that the current linear dosage (in milligrams per kilogram of body weight) is too low for children and that a new dosing algorithm based on an appropriate body size model would result in an optimal exposure. A population PK analysis was performed on three historic pooled data sets, including Indian children, Indian adults, and European adults. Linear and allometric scaling of PK parameters by either body weight or fat-free mass (FFM) was evaluated for body size models. Based on the developed PK model, a dosing algorithm for miltefosine in children and adults was proposed and evaluated in silico. The population PK model employing allometric scaling fitted best to the pooled miltefosine data. Allometric scaling by FFM reduced between-subject variability, e.g., for drug clearance, from 49.6% to 32.1%. A new allometric miltefosine dosing algorithm was proposed. Exposure to miltefosine was lower in children than adults receiving 2.5 mg/kg/day: a C(max) of 18.8 μg/ml was reached by 90% of adults and 66.7% of children. The allometric daily dose resulted in similar levels of exposure to miltefosine for adults and children. The use of a new allometric dosing algorithm for miltefosine in VL patients results in optimal exposure to miltefosine in both adults and children and might improve clinical outcome in children.

Indexed as

AdolescentAdultAntiprotozoal AgentsChildChild, PreschoolDrug Administration ScheduleFemaleHumansLeishmaniasis, VisceralMaleMiddle AgedPhosphorylcholineYoung AdultAntiprotozoal AgentsmiltefosinePhosphorylcholine

Identifiers

PMID22585212
PMCPMC3393397

What OpenQuestion holds

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Registered trials

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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.