Evidence map›Paper›PMID 36394316›Full record

ArticleAntimicrobial agents and chemotherapy2022

Safety of Ceftazidime-Avibactam in Combination with Aztreonam (COMBINE) in a Phase I, Open-Label Study in Healthy Adult Volunteers.

Thomas P Lodise, J Nicholas O'Donnell, Shruti Raja, Jeffrey T Guptill, Smitha Zaharoff, Nyssa Schwager, Vance G Fowler, Tatiana Beresnev, Alison Wall, Katherine Wiegand and 4 more

Open access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Antimicrobial agents and chemotherapy, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.5field-weighted citation impact, top 18% 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

16 citing papers in PubMed, 21 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Article
  6. Review
  7. Review
  8. Carbapenem-ResistantCase reports in infectious diseases · 2025
    Article
  9. Article
  10. Review
  11. Article
  12. The Antibacterial Resistance Leadership Group: Scientific Advancements and Future Directions.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  13. Priorities and Progress in Gram-negative Bacterial Infection Research by the Antibacterial Resistance Leadership Group.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  14. Frontiers in medicine · 2023
    Article
  15. Article
  16. Reviewing novel treatment options for carbapenem-resistantExpert review of anti-infective therapy
    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

14 authors at 5 institutions in 1 country.

Thomas P LodiseAlbany College of Pharmacy and Health Sciencesgrid.413555.3, Albany, New York, USA.ORCID 0000-0002-4730-0655
J Nicholas O'DonnellAlbany College of Pharmacy and Health Sciencesgrid.413555.3, Albany, New York, USA.ORCID 0000-0001-5184-1385
Shruti RajaDuke Early Phase Clinical Research Unit, Duke Universitygrid.26009.3d School of Medicine, Durham, North Carolina, USA.ORCID 0000-0003-0216-1564
Jeffrey T GuptillDuke Early Phase Clinical Research Unit, Duke Universitygrid.26009.3d School of Medicine, Durham, North Carolina, USA.
Smitha ZaharoffDuke Clinical Research Institute, Duke Universitygrid.26009.3d School of Medicine, Durham, North Carolina, USA.
Nyssa SchwagerDuke Clinical Research Institute, Duke Universitygrid.26009.3d School of Medicine, Durham, North Carolina, USA.
Vance G FowlerDuke Clinical Research Institute, Duke Universitygrid.26009.3d School of Medicine, Durham, North Carolina, USA.ORCID 0000-0002-8048-0897
Tatiana BeresnevDivision of Microbiology and Infectious Diseases (DMID), National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Bethesda, Maryland, USA.ORCID 0000-0001-9543-0107
Alison WallThe Emmes Company, Rockville, Maryland, USA.ORCID 0000-0002-6720-0977
Katherine WiegandThe Emmes Company, Rockville, Maryland, USA.
Elisavet Serti ChrisosThe Emmes Company, Rockville, Maryland, USA.ORCID 0000-0003-4129-0254
Stephen BalevicDuke Clinical Research Institute, Duke Universitygrid.26009.3d School of Medicine, Durham, North Carolina, USA.
Henry F ChambersUniversity of California, San Francisco, and San Francisco General Hospital, San Francisco, California, USA.ORCID 0000-0001-5317-4491
Antibacterial Resistance Leadership Group
Duke University · USEmmes (United States) · USAlbany College of Pharmacy and Health Sciences · USNational Institutes of Health · USSan Francisco General Hospital · US

Funding

Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
Statistical Data Coordinating Center: Monkeypox Clinical Research Support75N93021C00012 · NIAID · THE EMMES COMPANY, LLC · PI EWELL, MARIAN · 2021 to 2025
$150.3M
Optimal Dosing for Biologic Agents in Obese Patients with Rheumatoid and Juvenile ArthritisK23AR075874 · NIAMS · DUKE UNIVERSITY · PI BALEVIC, STEPHEN JOSEPH · 2020 to 2024
$830k
NIAID NIH HHS 75N93021C00012NIAID NIH HHS UM1 AI104681
6 · The paper itself

Abstract

This phase I study evaluated the safety of the optimal ceftazidime-avibactam (CZA) with aztreonam (ATM) regimens identified in hollow fiber infection models of MBL-producing Enterobacterales. Eligible healthy subjects aged 18 to 45 years were assigned to one of six cohorts: 2.5 g CZA over 2 h every 8 h (approved dose), CZA continuous infusion (CI) (7.5 g daily), 2 g ATM over 2 h every 6 h, ATM CI (8 g daily), CZA (approved dose) with 1.5 g ATM over 2 h every 6 h, and CZA (approved dose) with 2 g ATM over 2 h every 6 h. Study drug(s) were administered for 7 days. The most frequently observed adverse events (AEs) were hepatic aminotransferase (ALT/AST) elevations (

Indexed as

Anti-Bacterial AgentsAztreonamAdultAzabicyclo Compoundsbeta-LactamasesCeftazidimeDrug CombinationsHealthy VolunteersHumansMicrobial Sensitivity TestsVolunteersAnti-Bacterial Agentsavibactam, ceftazidime drug combinationAzabicyclo CompoundsAztreonambeta-LactamasesCeftazidimeDrug Combinationsaztreonamceftazidime-avibactamclinical trialssafety

Identifiers

PMID36394316
PMCPMC9764989
OpenAlexW4309244714

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.