Evidence map›Paper›PMID 34350251›Full record

ArticleAnnals of translational medicine2021

Pharmacokinetics, pharmacodynamics, and safety of single- and multiple-dose intravenous ceftobiprole in healthy Chinese participants.

Wan-Zhen Li, Hai-Lan Wu, Yuan-Cheng Chen, Bei-Ning Guo, Xiao-Fen Liu, Yu Wang, Ju-Fang Wu, Jing Zhang

Open access · diamondAbstract read
In one paragraph

Article in Annals of translational medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.2field-weighted citation impact, top 51% 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

4 citing papers in PubMed, 4 citations in OpenAlex.

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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 at 2 institutions in 1 country.

Wan-Zhen LiInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Hai-Lan WuInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Yuan-Cheng ChenInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Bei-Ning GuoInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Xiao-Fen LiuInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Yu WangInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Ju-Fang WuInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Jing ZhangInstitute of Antibiotics, Huashan Hospital, Fudan University, Shanghai, China.
Fudan University · CNHuashan Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCeftobiprole is a novel β-lactam cephalosporin with activity against Gram-positive and -negative bacteria. The aim of the present study was to investigate the pharmacokinetics (PK), pharmacokinetics/pharmacodynamics (PK/PD), safety and tolerance of ceftobiprole in Chinese participants, to evaluate this dosage regimen for the treatment of community-acquired pneumonia (CAP) and hospital-acquired pneumonia (HAP) in China.

methodsThe use of ceftobiprole was investigated in a single-center, open-label, single- and multiple-dose study using 12 healthy Chinese participants (6 males and 6 females). Ceftobiprole plasma and urine concentrations were analyzed using a validated liquid chromatography-tandem mass spectrometry assay. The PK/PD characteristics of 500 mg ceftobiprole every 8 h at 1.5-, 2-, 3-, or 4-h infusion time were analyzed by Monte Carlo simulations (MCS).

resultsThe maximum plasma concentration of ceftobiprole was observed 2 h after dosage; its terminal half-life was about 3 h. Ceftobiprole was predominantly eliminated in urine, and the cumulative excretion in 24 h was >90%. There was no accumulation after multiple dosing. Both single and multiple doses were well tolerated, with no severe or serious adverse events (AEs). PK/PD analysis indicated that

conclusionsThe PK/PD results indicated that 500 mg ceftobiprole every 8 h at 2-h infusion time is expected to achieve good microbiological efficacy in the treatment of CAP and HAP in China.

Indexed as

CeftobiproleMonte Carlo simulation (MCS)pharmacokinetic/pharmacodynamic analysis (PK/PD analysis)

Identifiers

PMID34350251
PMCPMC8263851
OpenAlexW3158544988

What OpenQuestion holds

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Registered trials

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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.