Evidence map›Paper›PMID 37676612›Full record

Trial reportClinical drug investigation2023

Pharmacokinetic and Exposure Response Analysis of the Double-Blind Randomized Study of Posaconazole and Voriconazole for Treatment of Invasive Aspergillosis.

Johan A Maertens, Galia Rahav, Dong-Gun Lee, Shariq Haider, Isabel Cristina Ramirez-Sanchez, Nikolai Klimko, Alfredo Ponce-de-León, Seongah Han, Rebecca Wrishko, Gregory A Winchell and 3 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01782131 (A Phase 3 Randomized Study of the Efficacy and Safety of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis in Adults and Adolescents), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 25% 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.

NCT01782131 phase3completednot on this map

A Phase 3 Randomized Study of the Efficacy and Safety of Posaconazole Versus Voriconazole for the Treatment of Invasive Aspergillosis in Adults and Adolescents (Phase 3; Protocol No. MK-5592-069)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2013 to 2019Enrolled585ConditionsFungal Infections, Invasive Pulmonary AspergillosisArmsPosaconazole, Voriconazole, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Article
  5. 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

13 authors at 9 institutions in 8 countries.

Johan A MaertensDepartment of Microbiology, Immunology, and Transplantation, KU Leuven, Herestraat 49 Campus, 3000, Leuven, Belgium. johan.maertens@uzleuven.be.
Galia RahavSheba Medical Center, Tel Hashomer, Ramat Gan, Israel.
Dong-Gun LeeDivision of Infectious Diseases, Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, South Korea.
Shariq HaiderJuravinski Hospital and Cancer Centre, McMaster University, Hamilton, ON, Canada.
Isabel Cristina Ramirez-SanchezHospital Pablo Tobón Uribe, Universidad de Antioquia, Medellín, Colombia.
Nikolai KlimkoNorth-Western State Medical University, St. Petersburg, Russia.
Alfredo Ponce-de-LeónInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán, Mexico City, Mexico.
Seongah HanMerck & Co., Inc., Rahway, NJ, USA.
Rebecca WrishkoMerck & Co., Inc., Rahway, NJ, USA.
Gregory A WinchellCertara USA, Inc., Princeton, NJ, USA.
Anjana GrandhiMerck & Co., Inc., Rahway, NJ, USA.
Hetty WaskinMerck & Co., Inc., Rahway, NJ, USA.
study investigators
Merck & Co., Inc., Rahway, NJ, USA (United States) · USCatholic University of Korea · KRInstituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán · MXIntegra LifeSciences (United States) · USJuravinski Hospital · CAKU Leuven · BENorth-Western State Medical University named after I.I. Mechnikov · RUSheba Medical Center · ILUniversidad de Antioquia · CO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveA double-blind phase 3 study was conducted to compare posaconazole 300 mg intravenously (IV)/300 mg orally once daily (twice daily day 1) with voriconazole 4 mg/kg IV twice daily/200 mg orally twice daily (6 mg/kg day 1) for treatment of invasive aspergillosis. This analysis was conducted to summarize the pharmacokinetics and exposure-response relationships of posaconazole and voriconazole using plasma trough concentration (C

methodsThe pharmacokinetic evaluable population included all intention-to-treat (ITT) participants with at least one plasma concentration during the treatment period. Treatment blinding was maintained without therapeutic drug monitoring. C

resultsThe pharmacokinetic analysis population included 506 of 575 ITT participants (437 with C

conclusionsA strong exposure-response relationship was not observed across the range of exposure from the administered doses and formulations for posaconazole or voriconazole.

trial registrationNCT01782131; registered January 30, 2013.

Indexed as

AspergillosisTriazolesDouble-Blind MethodHumansVoriconazoleposaconazoleTriazolesVoriconazole

Identifiers

PMID37676612
PMCPMC10514181
OpenAlexW4386501607

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.