Evidence map›Paper›PMID 16304177›Full record

Trial reportAntimicrobial agents and chemotherapy2005

Population pharmacokinetics of amphotericin B lipid complex in neonates.

Gudrun Würthwein, Andreas H Groll, Georg Hempel, Felice C Adler-Shohet, Jay M Lieberman, Thomas J Walsh

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 1 pooled it
6.1field-weighted citation impact, top 4% of its field
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

30 citing papers in PubMed, 1 synthesis or guideline pooled it, 111 citations in OpenAlex.

  1. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2009
    Guideline
  2. Trial
  3. Population pharmacokinetics of teicoplanin in children.Antimicrobial agents and chemotherapy · 2014
    Trial
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Review
  13. Advances in the treatment of invasive neonatal candidiasis.Expert opinion on pharmacotherapy · 2015
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review
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

6 authors at 2 institutions in 1 country.

Gudrun WürthweinInfectious Disease Research Program, Center for Bone Marrow Transplantation and Department of Pediatric Hematology/Oncology, Children's University Hospital, Muenster, Federal Republic of Germany.
Andreas H Groll
Georg Hempel
Felice C Adler-Shohet
Jay M Lieberman
Thomas J Walsh
Miller Children's & Women's Hospital · USNational Cancer Institute · US

Funding

Treatment of Infections in Immunocompromised Children with Cancer, HematopoieticZ01SC006830 · SC · DIVISION OF CLINICAL SCIENCES - NCI · PI WALSH, THOMAS J. · 1996 to 2008
$5.8M
Treatment of Infections in Immunocompromised ChildrenZIASC006830 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI WALSH, THOMAS J. · 2009 to 2009
$2.4M
6 · The paper itself

Abstract

The pharmacokinetics of amphotericin B lipid complex (ABLC) were investigated in neonates with invasive candidiasis enrolled in a phase II multicenter trial. Sparse blood (153 samples; 1 to 9 per patient, 1 to 254 h after the dose) and random urine and cerebrospinal fluid (CSF) samples of 28 neonates (median weight [WT], 1.06 kg; range, 0.48 to 4.9 kg; median gestational age, 27 weeks; range, 24 to 41 weeks) were analyzed. Patients received intravenous ABLC at 2.5 (n = 15) or 5 (n = 13) mg/kg of body weight once a day over 1 or 2 h, respectively, for a median of 21 days (range, 4 to 47 days). Concentrations of amphotericin B were quantified as total drug by high-performance liquid chromatography. Blood data for time after dose (TAD) of <24 h fitted best to a one-compartment model with an additive-error model for residual variability, WT0.75 (where 0.75 is an exponent) as a covariate of clearance (CL), and WT as a covariate of volume of distribution (V). Prior amphotericin B, postnatal age, and gestational age did not further improve the model. The final model equations were CL (liters/h) = 0.399 x WT(0.75) (interindividual variability, 35%) and V (liters) = 10.5 x WT (interindividual variability, 43%). Noncompartmental analysis of pooled data with a TAD of >24 h revealed a terminal half-life of 395 h. Mean concentrations in the urine after 1, 2, and 3 weeks ranged from 0.082 to 0.430 microg/ml, and those in CSF ranged from undetectable to 0.074 microg/ml. The disposition of ABLC in neonates was similar to that observed in other age groups: weight was the only factor that influenced clearance. Based on these results and previously published safety and efficacy data, we recommend a daily dosage between 2.5 and 5.0 mg/kg for treatment of invasive Candida infections in neonates.

Indexed as

Amphotericin BAnti-Infective AgentsCandidaCandidiasisDrug CombinationsHumansInfant, NewbornModels, BiologicalPhosphatidylcholinesPhosphatidylglycerolsAmphotericin BAnti-Infective AgentsDrug Combinationsliposomal amphotericin BPhosphatidylcholinesPhosphatidylglycerols

Identifiers

PMID16304177
PMCPMC1315949
OpenAlexW2116359244

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.