Evidence map›Paper›PMID 29578585›Full record

ArticleJournal of clinical pharmacology2018

Clinical Pharmacokinetics of Sulfobutylether-β-Cyclodextrin in Patients With Varying Degrees of Renal Impairment.

Randall K Hoover, Harry Alcorn, Laura Lawrence, Susan K Paulson, Megan Quintas, David R Luke, Sue K Cammarata

Abstract readClinical Trial, Phase I
In one paragraph

Article in Journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 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

18 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Efficacy and Safety of Remdesivir in People With Impaired Kidney Function Hospitalized for COVID-19 Pneumonia: A Randomized Clinical Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024
    Trial
  4. Article
  5. Review
  6. Article
  7. Therapeutic advances in COVID-19.Nature reviews. Nephrology · 2023
    Review
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Observational
  14. Article
  15. Article
  16. Review
  17. Clinical Pharmacokinetics and Pharmacodynamics of Delafloxacin.European journal of drug metabolism and pharmacokinetics · 2019
    Review
  18. Necrotizing orbital infections: A comprehensive review.Saudi journal of ophthalmology : official journal of the Saudi Ophthalmological Society
    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

7 authors.

Randall K HooverPharmacology Consultant, Bel Air, MD, USA.ORCID 0000-0002-5852-606X
Harry AlcornDaVita Clinical Research, Minneapolis, MN, USA.
Laura LawrenceMelinta Therapeutics, Inc, Lincolnshire, IL, USA.
Susan K PaulsonFirma Clinical Research, Chicago, IL, USA.
Megan QuintasMelinta Therapeutics, Inc, Lincolnshire, IL, USA.
David R LukeMelinta Therapeutics, Inc, Lincolnshire, IL, USA.
Sue K CammarataMelinta Therapeutics, Inc, Lincolnshire, IL, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Delafloxacin, a fluoroquinolone, has activity against Gram-positive organisms including methicillin-resistant S aureus and fluoroquinolone-susceptible and -resistant Gram-negative organisms. The intravenous formulation of delafloxacin contains the excipient sulfobutylether-β-cyclodextrin (SBECD), which is eliminated by renal filtration. This study examined the pharmacokinetics and safety of SBECD after single intravenous (IV) infusions in subjects with renal impairment. The study was an open-label, parallel-group, crossover study in subjects with normal renal function or mild, moderate, or severe renal impairment, and those with end-stage renal disease undergoing hemodialysis. Subjects received 300 mg delafloxacin IV or placebo IV, containing 2400 mg SBECD, in 2 periods separated by ≥14-day washouts. SBECD total clearance decreased with decreasing renal function, with a corresponding increase in area under the concentration-time curve (AUC

Indexed as

Administration, OralAdultAgedAnti-Infective Agentsbeta-CyclodextrinsCross-Over StudiesExcipientsFemaleFluoroquinolonesHealthy VolunteersHumansInfusions, IntravenousKidney Failure, ChronicMaleMetabolic Clearance RateMiddle AgedAnti-Infective Agentsbeta-CyclodextrinsdelafloxacinExcipientsFluoroquinolonesSBE4-beta-cyclodextrinDelafloxacinHemodialysisPharmacokineticsRenal DysfunctionSulfobutylether-β-cyclodextrin

Identifiers

PMID29578585
PMCPMC6718009

What OpenQuestion holds

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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.