Evidence map›Paper›PMID 24733463›Full record

ArticleAntimicrobial agents and chemotherapy2014

Phase 1B study of the pharmacokinetics and safety of posaconazole intravenous solution in patients at risk for invasive fungal disease.

Johan Maertens, Oliver A Cornely, Andrew J Ullmann, Werner J Heinz, Gopal Krishna, Hernando Patino, Maria Caceres, Nicholas Kartsonis, Hetty Waskin, Michael N Robertson

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01075984 (Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension), which is not on this map. Cited by 31 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 4 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.

NCT01075984 phase1completednot on this map

Pharmacokinetics, Safety, and Tolerability of Intravenous Posaconazole Solution Followed by Oral Posaconazole Suspension (SCH 56592) in Subjects at High Risk for Invasive Fungal Infections (Phase 1b; Protocol No. P05520)

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2010 to 2012Enrolled279ConditionsFungal InfectionArmsPosaconazole, Dextrose 5% in water
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Pooled it
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  14. Characterization of Therapeutic Drug Monitoring Practices of Voriconazole and Posaconazole at a Pediatric Hospital.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021
    Article
  15. Review
  16. Observational
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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

10 authors.

Johan MaertensUniversity Hospital Gasthuisberg, Leuven, Belgium johan.maertens@uzleuven.be.
Oliver A CornelyUniversity Hospital, Cologne, Germany.
Andrew J UllmannJohannes Gutenberg University, Mainz, Germany.
Werner J HeinzJulius-Maximilians-Universität Würzburg, Germany.
Gopal KrishnaMerck & Co., Inc., Whitehouse Station, New Jersey, USA.
Hernando PatinoMerck & Co., Inc., Whitehouse Station, New Jersey, USA.
Maria CaceresMerck & Co., Inc., Whitehouse Station, New Jersey, USA.
Nicholas KartsonisMerck & Co., Inc., Whitehouse Station, New Jersey, USA.
Hetty WaskinMerck & Co., Inc., Whitehouse Station, New Jersey, USA.
Michael N RobertsonMerck & Co., Inc., Whitehouse Station, New Jersey, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This was a phase 1B, dose-ranging, multicenter, pharmacokinetics, and safety study of cyclodextrin-based posaconazole intravenous (i.v.) solution administered through a central line to subjects at high risk for invasive fungal disease (part 1 of a 2-part study [phase 1B/3]). Initially, the safety and tolerability of single-dose posaconazole i.v. 200 mg (n = 10) were compared with those of a placebo (n = 11). Subsequently, 2 doses were evaluated, posaconazole i.v. 200 mg once daily (q.d.) (n = 21) and 300 mg q.d. (n = 24). The subjects received twice-daily (b.i.d.) posaconazole i.v. on day 1, followed by 13 days of posaconazole i.v. q.d., then 14 days of posaconazole oral suspension 400 mg b.i.d. The steady-state (day 14) exposure target (average concentration [areas under concentration-time curve {AUCs}/24 h, average concentrations at steady state {Cavgs}], of ≥ 500 to ≤ 2,500 ng/ml in ≥ 90% of the subjects) was achieved by 94% of the subjects for 200 mg posaconazole q.d. and by 95% of subjects for 300 mg posaconazole q.d. The desired exposure target (mean steady-state Cavg, ∼ 1,200 ng/ml) was 1,180 ng/ml in the 200-mg dosing cohort and was exceeded in the 300-mg dosing cohort (1,430 ng/ml). Posaconazole i.v. was well tolerated. Posaconazole i.v. 300 mg q.d. was selected for the phase 3 study segment. (This study has been registered at ClinicalTrials.gov under registration no. NCT01075984.).

Indexed as

AdultAgedAntifungal AgentsCohort StudiesDose-Response Relationship, DrugFemaleHumansInjections, IntravenousMaleMiddle AgedMycosesPharmaceutical SolutionsTriazolesAntifungal AgentsPharmaceutical SolutionsposaconazoleTriazoles

Identifiers

PMID24733463
PMCPMC4068540

What OpenQuestion holds

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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.