Evidence map›Paper›PMID 29891609›Full record

ArticleAntimicrobial agents and chemotherapy2018

Population Pharmacokinetics and Safety of Solithromycin following Intravenous and Oral Administration in Infants, Children, and Adolescents.

Daniel Gonzalez, Laura P James, Amira Al-Uzri, Miroslava Bosheva, Felice C Adler-Shohet, Susan R Mendley, John S Bradley, Claudia Espinosa, Eva Tsonkova, Kathryn Moffett and 9 more

Open access · bronzeAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.6field-weighted citation impact, top 29% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

19 authors at 15 institutions in 2 countries.

Daniel GonzalezDivision of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, North Carolina, USA.
Laura P JamesArkansas Children's Hospital Research Institute, Little Rock, Arkansas, USA.
Amira Al-UzriOregon Health and Science University, Portland, Oregon, USA.
Miroslava BoshevaMedical University, Plovdiv, Bulgaria.
Felice C Adler-ShohetChildren's Hospital of Orange County (CHOC), Orange, California, USA.
Susan R MendleyUniversity of Maryland School of Medicine, Baltimore, Maryland, USA.
John S BradleyRady Children's Hospital, San Diego, California, USA.
Claudia EspinosaUniversity of Louisville School of Medicine and Kosair Charities Pediatric Clinical Research Unit, Louisville, Kentucky, USA.
Eva TsonkovaMultiprofile Hospital for Active Treatment, Ruse, Bulgaria.
Kathryn MoffettWest Virginia University Hospital, Morgantown, West Virginia, USA.
Lucila MarquezBaylor College of Medicine, Houston, Texas, USA.
Kari A SimonsenUniversity of Nebraska Medical Center, Omaha, Nebraska, USA.
Stefan StoilovUniversity Multiprofile Hospital for Active Treatment and Emergency Medicine N. I. Pirogov, Sofia, Bulgaria.
Felix Boakye-AgyemanDuke Clinical Research Institute, Durham, North Carolina, USA.
Theresa JasionDuke Clinical Research Institute, Durham, North Carolina, USA.
Christoph P HornikDuke Clinical Research Institute, Durham, North Carolina, USA.
Robert HernandezMelinta Therapeutics, Inc., Chapel Hill, North Carolina, USA.
Daniel K BenjaminDuke Clinical Research Institute, Durham, North Carolina, USA.
Michael Cohen-WolkowiezDuke Clinical Research Institute, Durham, North Carolina, USA michael.cohenwolkowiez@duke.edu.
Clinical Research Institute · USDuke University · USNational Institute of Emergency Medicine "Pirogov" · BGArkansas Children's Hospital · USBaylor College of Medicine · USChildren's Hospital of Orange County · USMedical University Plovdiv · BGMelinta Therapeutics (United States) · USOregon Health & Science University · USUniversity of California San Diego Medical Center · USUniversity of Louisville · USUniversity of Maryland, Baltimore · USUniversity of Nebraska Medical Center · USUniversity of North Carolina at Chapel Hill · USWest Virginia University Hospitals · US

Funding

Oregon Clinical and Translational Research Institute - The National COVID Cohort Collaborative (N3C)UL1TR002369 · NCATS · OREGON HEALTH & SCIENCE UNIVERSITY · PI Cynthia D Morris, Christopher G. Slatore · 2017 to 2026
$78.4M
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
NCATS NIH HHS UL1 TR002369NICHD NIH HHS K23 HD083465
6 · The paper itself

Abstract

Solithromycin is a novel fluoroketolide antibiotic which was under investigation for the treatment of community-acquired bacterial pneumonia (CABP). A phase 1 study was performed to characterize the pharmacokinetics (PK) and safety of solithromycin in children. Eighty-four subjects (median age, 6 years [age range, 4 days to 17 years]) were administered intravenous (i.v.) or oral (capsules or suspension) solithromycin (i.v., 6 to 8 mg/kg of body weight; capsules/suspension, 14 to 16 mg/kg on days 1 and 7 to 15 mg/kg on days 2 to 5). PK samples were collected after the first and multidose administration. Data from 83 subjects (662 samples) were combined with previously collected adolescent PK data (

Indexed as

Administration, IntravenousAdministration, OralAdolescentAdultAgedAged, 80 and overChildChild, PreschoolFemaleHumansInfantInfant, NewbornMacrolidesMaleMiddle AgedTriazolesMacrolidessolithromycinTriazolesantibioticspediatricspharmacokineticssafetysolithromycin

Identifiers

PMID29891609
PMCPMC6105834
OpenAlexW2889564182

What OpenQuestion holds

Textmetadata
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.