Evidence map›Paper›PMID 26883693›Full record

ArticleAntimicrobial agents and chemotherapy2016

Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.

Daniel Gonzalez, Debra L Palazzi, Leena Bhattacharya-Mithal, Amira Al-Uzri, Laura P James, John Bradley, Natalie Neu, Theresa Jasion, Christoph P Hornik, P Brian Smith and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01966055 (A Phase 1, Open-label, Multi-center Study to Determine the PK and Safety of Solithromycin as Add-on Therapy in Adolescents With Suspected or Confirmed Bacterial Infection), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
3.4field-weighted citation impact, top 9% 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.

NCT01966055 phase1completednot on this map

A Phase 1, Open-label, Multi-center Study to Determine the PK and Safety of Solithromycin as Add-on Therapy in Adolescents With Suspected or Confirmed Bacterial Infection

TypeinterventionalSponsorMelinta Therapeutics, Inc.Ran2013 to 2014Enrolled13ConditionsBacterial InfectionsArmsSolithromycin
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 15 citations in OpenAlex.

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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

14 authors at 10 institutions in 1 country.

Daniel GonzalezDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA.
Debra L PalazziInfectious Diseases Section, Baylor College of Medicine, Houston, Texas, USA.
Leena Bhattacharya-MithalAnn and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.
Amira Al-UzriOregon Health & Science University, Portland, Oregon, USA.
Laura P JamesArkansas Children's Hospital Research Institute, Little Rock, Arkansas, USA.
John BradleyUniversity of California San Diego Medical Center, San Diego, California, USA.
Natalie NeuColumbia University Medical Center, New York, New York, USA.
Theresa JasionDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Christoph P HornikDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
P Brian SmithDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
Daniel K BenjaminDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA.
Kara KeedyCempra, Inc., Chapel Hill, North Carolina, USA.
Prabhavathi FernandesCempra, Inc., Chapel Hill, North Carolina, USA.
Michael Cohen-WolkowiezDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina, USA michael.cohenwolkowiez@duke.edu.
Duke University · USCempra Pharmaceuticals (United States) · USClinical Research Institute · USArkansas Children's Hospital · USBaylor College of Medicine · USColumbia University Irving Medical Center · USLurie Children's Hospital · USOregon Health & Science University · USUniversity of California San Diego Medical Center · USUniversity of North Carolina at Chapel Hill · US

Funding

Duke CTSA (Composite)UL1TR001117 · NCATS · DUKE UNIVERSITY · PI BOULWARE, LEIGH E, LI, JENNIFER S · 2013 to 2017
$41.3M
Fungal biomarkers for diagnosis and response to therapy for pediatric candidemiaR01HD081044 · NICHD · DUKE UNIVERSITY · PI FISHER, BRIAN T, STEINBACH, WILLIAM J · 2014 to 2018
$3.2M
Physiologically-Based Pharmacokinetic Models for Optimal Drug Dosing in ChildrenR01HD076676 · NICHD · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2014 to 2017
$2.6M
Mentorship of early-career pediatricians in quantitiative methods and therapeuticK24HD058735 · NICHD · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K. · 2009 to 2018
$1.5M
Use of Physiologically-Based PK/PD Models to Streamline Drug ApprovalsK23HD083465 · NICHD · UNIV OF NORTH CAROLINA CHAPEL HILL · PI GONZALEZ, DANIEL · 2015 to 2019
$727k
Clinical Practice Data to Aid Narrow Therapeutic Index Drug ClassificationU01FD004858 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL · 2013 to 2014
$497k
FDA HHS U01 FD004858NCATS NIH HHS UL1 TR001117NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017INIAID NIH HHS HHSN272201500001CNIAID NIH HHS HHSN272201500001GNIAID NIH HHS HHSN272201500006CNICHD NIH HHS HHSN275201000001GNICHD NIH HHS HHSN275201000001ZNICHD NIH HHS HHSN275201000003CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K23 HD083465NICHD NIH HHS K24 HD058735NICHD NIH HHS R01 HD076676NICHD NIH HHS R01 HD081044
6 · The paper itself

Abstract

We assessed the pharmacokinetics and safety of solithromycin, a fluoroketolide antibiotic, in a phase 1, open-label, multicenter study of 13 adolescents with suspected or confirmed bacterial infections. On days 3 to 5, the mean (standard deviation) maximum plasma concentration and area under the concentration versus time curve from 0 to 24 h were 0.74 μg/ml (0.61 μg/ml) and 9.28 μg · h/ml (6.30 μg · h/ml), respectively. The exposure and safety in this small cohort of adolescents were comparable to those for adults. (This study has been registered at ClinicalTrials.gov under registration no. NCT01966055.).

Indexed as

AdolescentAdultAnti-Bacterial AgentsArea Under CurveBacterial InfectionsChildDried Blood Spot TestingFemaleHumansMacrolidesMalePatient SafetyTriazolesAnti-Bacterial AgentsMacrolidessolithromycinTriazoles

Identifiers

PMID26883693
PMCPMC4808196
OpenAlexW2286295378

What OpenQuestion holds

Textmetadata
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.