Evidence map›Paper›PMID 19029316›Full record

Trial reportAntimicrobial agents and chemotherapy2009

Intrapulmonary pharmacokinetics and pharmacodynamics of posaconazole at steady state in healthy subjects.

John E Conte, Jeffrey A Golden, Gopal Krishna, Marina McIver, Emily Little, Elisabeth Zurlinden

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 3 pooled it
4.5field-weighted citation impact, top 5% 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

44 citing papers in PubMed, 3 syntheses or guidelines pooled it, 85 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Microbiology spectrum · 2022
    Article
  17. Article
  18. Review
  19. Review
  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

6 authors at 1 institution in 1 country.

John E ConteAmerican Health Sciences, San Francisco, California. john.conte@ucsf.edu
Jeffrey A Golden
Gopal Krishna
Marina McIver
Emily Little
Elisabeth Zurlinden
University of California, San Francisco · US

Funding

ZD1839 FOR MALIGNANT ASTROCYTOMA OR GLIOBLASTOMA AND MENINGIOMAM01RR000079 · NCRR · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI KESSLER, DAVID A · 1985 to 2006
$26.0M
NCRR NIH HHS M01 RR000079NCRR NIH HHS MO1RR00079
6 · The paper itself

Abstract

We evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of posaconazole (POS) in a prospective, open-label study. Twenty-five healthy adults received 14 doses of POS oral suspension (400 mg twice daily) with a high-fat meal over 8 days. Pulmonary epithelial lining fluid (ELF) and alveolar cell (AC) samples were obtained via bronchoalveolar lavage, and blood samples were collected during the 24 h after the last dose. POS concentrations were determined using liquid chromatography with tandem mass spectrometry parameters. The maximum concentrations (C(max)) (mean +/- standard deviation) in plasma, ELF, and ACs were 2.08 +/- 0.93, 1.86 +/- 1.30, and 87.7 +/- 65.0 microg/ml. The POS concentrations in plasma, ELF, and ACs did not decrease significantly, indicating slow elimination after multiple dosing. The mean concentrations of POS in plasma, ELF, and ACs were above the MIC(90) (0.5 microg/ml) for Aspergillus spp. over the 12-h dosing interval and for 24 h following the last dose. Area under the curve from 0 to 12 h (AUC(0-12)) ratios for ELF/plasma and AC/plasma were 0.84 and 33. AUC(0-24)/MIC(90) ratios in plasma, ELF, and AC were 87.6, 73.2, and 2,860. Nine (36%) of 25 subjects had treatment-related adverse events during the course of the study, which were all mild or moderate. We conclude that a dose of 400 mg twice daily resulted in sustained plasma, ELF, and AC concentrations above the MIC(90) for Aspergillus spp. during the dosing interval. The intrapulmonary PK/PD of POS are favorable for treatment or prevention of aspergillosis, and oral POS was well tolerated in healthy adults.

Indexed as

AdultAntifungal AgentsArea Under CurveAspergillusBronchoalveolar Lavage FluidBronchoscopyEpitheliumFemaleHumansLungMaleMicrobial Sensitivity TestsMiddle AgedProtein BindingPulmonary AlveoliTriazolesAntifungal AgentsposaconazoleTriazoles

Identifiers

PMID19029316
PMCPMC2630621
OpenAlexW2009220652

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.