Evidence map›Paper›PMID 24771634›Full record

Trial reportJournal of clinical pharmacology2014

Systemic pharmacokinetics and cerebrospinal fluid uptake of intravenous ceftriaxone in patients with amyotrophic lateral sclerosis.

Yanli Zhao, Merit E Cudkowicz, Jeremy M Shefner, Lisa Krivickas, William S David, Francine Vriesendorp, Alan Pestronk, James B Caress, Jonathan Katz, Ericka Simpson and 7 more

Erratum issuedOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical pharmacology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.3field-weighted citation impact, top 19% 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

7 citing papers in PubMed, 15 citations in OpenAlex.

  1. Review
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

17 authors at 13 institutions in 1 country.

Yanli ZhaoProgram in Pharmacology and Experimental Therapeutics, Tufts University School of Medicine, Boston, MA, USA.
Merit E Cudkowicz
Jeremy M Shefner
Lisa Krivickas
William S David
Francine Vriesendorp
Alan Pestronk
James B Caress
Jonathan Katz
Ericka Simpson
Jeffrey Rosenfeld
Robert Pascuzzi
Jonathan Glass
Kourosh Rezania
Jerold S Harmatz
David Schoenfeld
David J Greenblatt
Tufts University · USHarvard University · USSUNY Upstate Medical University · USBaim Institute for Clinical Research · USCalifornia Pacific Medical Center · USCalifornia State University, Fresno · USEmory University · USHouston Methodist · USIndiana University – Purdue University Indianapolis · USMassachusetts General Hospital · USUniversity of Chicago · USWake Forest University · USWashington University in St. Louis · US

Funding

Washington University Institute of Clinical and Translational SciencesUL1TR000448 · NCATS · WASHINGTON UNIVERSITY · PI EVANOFF, BRADLEY A · 2012 to 2016
$41.4M
Clinical Trial of Ceftriaxone in Subjects with ALSU01NS049640 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI CUDKOWICZ, MERIT E · 2006 to 2012
$37.7M
Quality Assurance and Quality Control Project Management: Improving Submissions and Study Conduct in the Human Subjects Research Prior Approval ProcessUL1TR002529 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI MOE, SHARON M, WIEHE, SARAH ELIZABETH · 2018 to 2022
$27.2M
Indiana Clinical and Translational Sciences InstituteUL1TR001108 · NCATS · INDIANA UNIVERSITY INDIANAPOLIS · PI DENNE, SCOTT C., SHEKHAR, ANANTHA · 2013 to 2017
$23.3M
Clinical Trial of Ceftriaxone in ALSR01NS049640 · NINDS · MASSACHUSETTS GENERAL HOSPITAL · PI CUDKOWICZ, MERIT E · 2004 to 2004
$1.6M
NCATS NIH HHS UL1 TR000448NCATS NIH HHS UL1 TR001108NINDS NIH HHS R01 NS049640NINDS NIH HHS U01 NS049640NINDS NIH HHS U01 NS049640-05
6 · The paper itself

Abstract

The cephalosporin antibiotic ceftriaxone was evaluated as a potential therapeutic agent for the treatment of amyotrophic lateral sclerosis (ALS). The pharmacokinetics (PK) of ceftriaxone in plasma and cerebrospinal fluid (CSF) were investigated in 66 participants in a previously reported clinical trial. Their mean age was 51 years, and 65% were male. Participants were randomly assigned to 1 of 3 treatment groups receiving intravenous infusions (mean duration: 25 minutes) every 12 hours of either: placebo and placebo; 2 g ceftriaxone and placebo; or 2 g ceftriaxone twice. Mean steady-state plasma PK variables were: volume of distribution, 14 L (0.17 L/kg); elimination half-life, 8-9 h; total clearance, 17-21 mL/min (0.22-0.25 mL/min/kg). Values were not different between dosage groups. CSF PK analysis, determined through sparse CSF sampling, indicated apparent entry and elimination half-life values of 1.0 and 34 hours, respectively. With both dosage regimens, CSF concentrations were maintained above the target threshold of 1.0 µM (0.55 µg/mL) as determined from in vitro models. The plasma and CSF PK profiles of ceftriaxone were used as a basis for planning the Phase 3 clinical trial of ceftriaxone in ALS.

Indexed as

Amyotrophic Lateral SclerosisAnti-Bacterial AgentsCeftriaxoneFemaleHalf-LifeHumansInfusions, IntravenousMaleMiddle AgedTissue DistributionAnti-Bacterial AgentsCeftriaxoneamyotrophic lateral sclerosisceftriaxonecerebrospinal fluid uptakeHPLC micromethodplasma pharmacokinetics

Identifiers

PMID24771634
PMCPMC4352577
OpenAlexW2152773668

What OpenQuestion holds

Textmetadata
LicenceTDM
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.