Evidence map›Paper›PMID 42008649›Full record

Trial reportAntimicrobial agents and chemotherapy2026

Plasma and intrapulmonary pharmacokinetics of ceftibuten and ledaborbactam in healthy male and female adults.

Keith A Rodvold, Mark H Gotfried, Carlos Fernando de Oliveira, Kathryn Lowe, Kamal A Hamed, Karine Litherland, Marc Engelhardt, Paul C McGovern

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Antimicrobial agents and chemotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06665555 (A Phase 1, Open-label Study to Evaluate the Safety and Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adult Participants), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT06665555 phase1completednot on this map

A Phase 1, Open-label Study to Evaluate the Safety and Plasma and Intrapulmonary Pharmacokinetics of Ceftibuten and Ledaborbactam in Healthy Adult Participants

TypeinterventionalSponsorBasilea PharmaceuticaRan2024 to 2025Enrolled34ConditionsPharmacokinetics, Healthy VolunteersArmsledaborbactam etzadroxil, ceftibuten
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Keith A RodvoldUniversity of Illinois Chicago, Chicago, Illinois, USA.ORCID 0000-0002-7200-7346
Mark H GotfriedPulmonary Associates, PA, Phoenix, Arizona, USA.
Carlos Fernando de OliveiraVenatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.ORCID 0009-0002-4989-4896
Kathryn LoweVenatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.
Kamal A HamedBasilea Pharmaceutica International Ltd, Allschwil, Switzerland.ORCID 0000-0003-1896-9736
Karine LitherlandBasilea Pharmaceutica International Ltd, Allschwil, Switzerland.ORCID 0009-0000-8243-0482
Marc EngelhardtBasilea Pharmaceutica International Ltd, Allschwil, Switzerland.ORCID 0000-0003-2432-0212
Paul C McGovernVenatorx Pharmaceuticals, Inc., Malvern, Pennsylvania, USA.ORCID 0000-0002-5906-2818

Funding

NIH HHS HHSN272201600029C
6 · The paper itself

Abstract

Ledaborbactam etzadroxil (LED-E) is an oral prodrug of ledaborbactam, a broad-spectrum β-lactamase inhibitor. In combination with ceftibuten (CTB), a third-generation oral cephalosporin, LED-E represents a potential oral β-lactam/β-lactamase inhibitor regimen for treating infections caused by drug-resistant Gram-negative pathogens. This phase 1, single-center, open-label study evaluated intrapulmonary concentrations of ledaborbactam (LED) and CTB in healthy adults. Participants in Group 1 received five oral doses of CTB/LED-E (600 mg/600 mg) every 12 h (q12h), and participants in Group 2 received five oral doses of CTB 600 mg q12h. Following the fifth dose, participants underwent a standardized single bronchoscopy with bronchoalveolar lavage (BAL). Twenty-eight participants in Group 1 and six participants in Group 2 were randomized and dosed. Among participants receiving CTB/LED-E, epithelial lining fluid (ELF) area under the concentration-time curve from 0 to 12 h (AUC

Indexed as

Anti-Bacterial Agentsbeta-Lactamase InhibitorsCeftibutenCephalosporinsLungAdministration, OralAdultArea Under Curvebeta Lactam AntibioticsBronchoalveolar Lavage FluidFemaleHumansMaleMiddle AgedThird Generation CephalosporinsYoung AdultAnti-Bacterial Agentsbeta Lactam Antibioticsbeta-Lactamase InhibitorsCeftibutenCephalosporinsThird Generation Cephalosporinsceftibutenepithelial lining fluidledaborbactam etzadroxilpharmacokineticspulmonary

Identifiers

PMID42008649
PMCPMC13231890

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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.