Evidence map›Paper›PMID 39581957›Full record

Trial reportClinical pharmacokinetics2024

Pharmacokinetics of Omadacycline in Adults with Cystic Fibrosis.

Madeline Sanders, Eunjin Hong, Peter S Chung, Adupa P Rao, Paul Beringer

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

Trial report in Clinical pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04460586 (Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis), which is not on this map. Cited by 1 paper.

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

NCT04460586 phase4completednot on this map

Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis

TypeinterventionalSponsorPaul BeringerRan2021 to 2023Enrolled9ConditionsCystic FibrosisArmsOmadacycline Injection [Nuzyra], Omadacycline Oral Tablet [Nuzyra]
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
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

5 authors.

Madeline Sanders *Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, Los Angeles, CA, USA.ORCID 0009-0005-8386-0907
Eunjin Hong *College of Pharmacy, CHA University, Seongnam-si, South Korea.ORCID 0000-0002-6696-3948
Peter S ChungDivision of Pulmonary and Clinical Care Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.ORCID 0000-0003-1813-2119
Adupa P RaoDivision of Pulmonary and Clinical Care Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.ORCID 0000-0002-0220-7131
Paul BeringerAlfred E. Mann School of Pharmacy and Pharmaceutical Sciences, University of Southern California, Los Angeles, CA, USA. beringer@usc.edu.ORCID 0000-0002-3744-3310

Funding

DOCTORAL AND POST-DOCTORAL TRAINING IN CRANIOFACIAL BIOLOGYT90DE021982 · NIDCR · UNIVERSITY OF SOUTHERN CALIFORNIA · PI PAINE, MICHAEL LANSDELL · 2011 to 2025
$6.2M
NIDCR NIH HHS T90 DE021982
6 · The paper itself

Abstract

backgroundOmadacycline offers a potential advancement in the management of infections in people with cystic fibrosis (CF) because of its spectrum of activity, intrapulmonary penetration, and oral bioavailability. A prospective single-dose, single-arm study was conducted to characterize the pharmacokinetic (PK) profile of omadacycline in people with CF, considering the known alterations in PK observed in this population (NCT04460586, 2020-07-01).

methodsPlasma samples were obtained from nine adults with CF who received a single dose of intravenous omadacycline 100 mg over 0.5 h followed by a 1-week washout and an oral dose of omadacycline 300 mg. The data were analyzed using noncompartmental PK.

resultsThe maximum plasma concentration (C

conclusionsOverall, the similarity in plasma PK observed in this study when comparing healthy volunteers and infected patients indicates that no dosing alterations are necessary when using omadacycline in people with CF.

Indexed as

Anti-Bacterial AgentsBiological AvailabilityCystic FibrosisTetracyclinesAdministration, IntravenousAdministration, OralAdultArea Under CurveFemaleHumansMaleMiddle AgedProspective StudiesYoung AdultAnti-Bacterial AgentsomadacyclineTetracyclines

Identifiers

PMID39581957
PMCPMC11649715

What OpenQuestion holds

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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.