Evidence map›Paper›PMID 39772650›Full record

Trial reportAntimicrobial agents and chemotherapy2025

Evaluation of the safety profile and intrapulmonary pharmacokinetics of intravenous fosfomycin in healthy adults.

Lindsay Boole, Zhonghui Yang, Stephen P Bergin, Robert M Tighe, Emily Randolph, Byron Hauser, Kenan Gu, Varduhi Ghazaryan, Alison Wall, Katherine Weigand and 2 more

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

Trial report in Antimicrobial agents and chemotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03910673 (A Phase 1 Safety and Intrapulmonary Pharmacokinetics Study of ZTI-01), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT03910673 phase1completednot on this map

A Phase 1 Safety and Intrapulmonary Pharmacokinetics Study of ZTI-01 (Intravenous Fosfomycin Disodium) in Healthy Adult Subjects

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2019 to 2020Enrolled39ConditionsBacterial Infection, Multiple-drug Resistance, Pathogen ResistanceArmsFosfomycin disodium
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  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

12 authors.

Lindsay BooleDivision of Pulmonary, Allergy, and Critical Care Medicine, Duke University School of Medicine, Durham, North Carolina, USA.ORCID 0009-0003-2010-1597
Zhonghui YangDivision of Pulmonary, Allergy, and Critical Care Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
Stephen P BerginDivision of Pulmonary, Allergy, and Critical Care Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
Robert M TigheDivision of Pulmonary, Allergy, and Critical Care Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
Emily RandolphDuke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.ORCID 0009-0006-4066-0056
Byron HauserDuke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Kenan GuDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Varduhi GhazaryanDivision of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Alison WallEmmes Company, Rockville, Maryland, USA.
Katherine WeigandEmmes Company, Rockville, Maryland, USA.
Emmanuel B WalterDuke Human Vaccine Institute, Duke University School of Medicine, Durham, North Carolina, USA.ORCID 0000-0001-6502-6736
Loretta G QueDivision of Pulmonary, Allergy, and Critical Care Medicine, Duke University School of Medicine, Durham, North Carolina, USA.ORCID 0000-0001-9188-9244

Funding

Statistical Data Coordinating Center: Monkeypox Clinical Research Support75N93021C00012 · NIAID · THE EMMES COMPANY, LLC · PI EWELL, MARIAN · 2021 to 2025
$150.3M
Support for QA/QC for Prior Approval ProcessUL1TR002553 · NCATS · DUKE UNIVERSITY · PI LI, JENNIFER S, MCNAMARA, JAMES O. · 2018 to 2023
$58.5M
HHS | NIH | National Center for Advancing Translational Sciences (NCATS) 5UL1-TR002553-05HHS | NIH | NIAID | Division of Microbiology and Infectious Diseases (DMID) HHSN75N93021C00012NCATS NIH HHS UL1 TR002553NIAID NIH HHS 75N93021C00012NIAID NIH HHS HHSN272201300017CNIAID NIH HHS HHSN272201300017I
6 · The paper itself

Abstract

This Phase 1 trial described the intrapulmonary pharmacokinetics and safety profile of IV fosfomycin in healthy participants CLINICAL TRIALS: This study is registered with ClinicalTrials.gov as NCT03910673.

Indexed as

Anti-Bacterial AgentsFosfomycinLungAdministration, IntravenousAdolescentAdultBronchoalveolar Lavage FluidFemaleHealthy VolunteersHumansMacrophages, AlveolarMaleMiddle AgedTandem Mass SpectrometryYoung AdultAnti-Bacterial AgentsFosfomycinbronchoscopyfosfomycinhealthy participantsintrapulmonary pharmacokinetics

Identifiers

PMID39772650
PMCPMC11823650

What OpenQuestion holds

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LicenceCC BY
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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.