Evidence map›Paper›PMID 35385974›Full record

Trial reportEuropean journal of clinical pharmacology2022

Pharmacokinetics of benapenem for injection in subjects with mild to moderate renal impairment.

Haijing Yang, Min Zhang, Yuancheng Chen, Hong Ren, Hong Zhang, Chen Yu, Jianda Lu, Li You, Jicheng Yu, Hong Liang and 5 more

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.2field-weighted citation impact, top 23% 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

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Review
  2. Novel Antimicrobial Agents for Gram-Negative Pathogens.Antibiotics (Basel, Switzerland) · 2023
    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

15 authors at 6 institutions in 1 country.

Haijing YangPhase I Unit, Huashan Hospital, Fudan University, No.12, Middle Wulumuqi Road, Shanghai, 200040, China.
Min ZhangDepartment of Nephrology, Huashan Hospital, Fudan University, No.12, Middle Wulumuqi Road, Shanghai, 200040, China.
Yuancheng ChenPhase I Unit, Huashan Hospital, Fudan University, No.12, Middle Wulumuqi Road, Shanghai, 200040, China.
Hong RenDepartment of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, 200025, China.
Hong ZhangPhase I Unit, Shanghai Tongji Hospital, Shanghai, 200065, China.
Chen YuDepartment of Nephrology, Shanghai Tongji Hospital, Shanghai, 200065, China.
Jianda LuNational Clinical Research Center for Geriatric Diseases (Huashan Hospital), Shanghai, 200040, China.
Li YouNational Clinical Research Center for Geriatric Diseases (Huashan Hospital), Shanghai, 200040, China.
Jicheng YuPhase I Unit, Huashan Hospital, Fudan University, No.12, Middle Wulumuqi Road, Shanghai, 200040, China.
Hong LiangPhase I Unit, Huashan Hospital, Fudan University, No.12, Middle Wulumuqi Road, Shanghai, 200040, China.
Cuilan XiaoXuanzhu Biopharmaceutical Co., Ltd, Beijing, 100025, China.
Zishuang HeXuanzhu Biopharmaceutical Co., Ltd, Beijing, 100025, China.
Jufang WuPhase I Unit, Huashan Hospital, Fudan University, No.12, Middle Wulumuqi Road, Shanghai, 200040, China.
Jun XueNational Clinical Research Center for Geriatric Diseases (Huashan Hospital), Shanghai, 200040, China. xuejun@fudan.edu.cn.
Jing ZhangPhase I Unit, Huashan Hospital, Fudan University, No.12, Middle Wulumuqi Road, Shanghai, 200040, China. zhangj_fudan@aliyun.com.ORCID http://orcid.org/0000-0003-2966-9149
Fudan University · CNSino Biopharmaceutical (China) · CNHuashan Hospital · CNNational Health and Family Planning Commission · CNRuijin Hospital · CNTongji Hospital · CN

Funding

Ministry of Science and Technology of the People's Republic of China 2017ZX09304005Shanghai Municipal Human Resources and Social Security Bureau 03
6 · The paper itself

Abstract

objectiveThis study evaluated the pharmacokinetic (PK) characteristics of benapenem in subjects with mild to moderate renal impairment to provide a reference for benapenem dosing regimens in this patient population.

methodsEighteen subjects were enrolled in this study. Each subject received a single dose of benapenem intravenously (1.0 g in 100 ml of 0.9% saline) followed by blood and urine collection to measure the concentrations of benapenem and its major metabolite. PK analysis was performed to evaluate the effect of varying degrees of renal impairment on the PK characteristics of benapenem. The safety of benapenem was also evaluated.

resultsIn subjects with normal renal function, mild renal impairment, and moderate renal impairment, the maximum plasma benapenem concentrations were 163 ± 6.58 mg/L, 138 ± 17.4 mg/L, and 134 ± 0.11 mg/L, respectively (15.3% and 17.8% lower in subjects with mild and moderate renal impairment, respectively, than in subjects with normal renal function). The areas under the plasma concentration-time curve (AUC

conclusionNo adjustment to benapenem dosing is needed in patients with mild to moderate renal impairment. CLINICAL

trial registrationDrug clinical trial registration and information publicity platform: http://www.chinadrugtrials.org.cn/index.html . REGISTRATION NUMBER: CTR20190760.

Indexed as

CarbapenemsRenal InsufficiencyArea Under CurveHumansInjectionsbenapenemCarbapenemsBenapenemDosingPharmacokineticsRenal impairmentSafetySubjects

Identifiers

PMID35385974
OpenAlexW4225577569

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.