Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.

Start Date01 Feb 2025

Sponsor / Collaborator

The General Hospital Corp.

[+1]

CTR20242272 / CompletedNot Applicable

头孢泊肟酯干混悬剂在健康受试者中单中心、随机、开放、两制剂、单次给药、两周期、双交叉空腹/餐后生物等效性试验

[Translation] A single-center, randomized, open-label, two-formulation, single-dose, two-period, double-crossover fasting/fed bioequivalence study of cefpodoxime proxetil dry suspension in healthy subjects

主要目的：以药代动力学参数作为主要终点评价指标，分别比较在空腹/餐后状态下口服受试制剂头孢泊肟酯干混悬剂（生产厂家：石家庄四药有限公司）与参比制剂头孢泊肟酯干糖浆（持证商：Daiichi Sankyo Co., Ltd.，商品名：BANAN）后在健康受试者体内的药代动力学行为，评价两种制剂的生物等效性。次要目的：观察受试制剂头孢泊肟酯干混悬剂和参比制剂头孢泊肟酯干糖浆在健康受试者中的安全性。

[Translation]

Primary objective: To compare the pharmacokinetic parameters as the primary endpoints of the pharmacokinetic behavior of the test preparation cefpodoxime proxetil dry suspension (manufacturer: Shijiazhuang No. 4 Pharmaceutical Co., Ltd.) and the reference preparation cefpodoxime proxetil dry syrup (licensed manufacturer: Daiichi Sankyo Co., Ltd., trade name: BANAN) in healthy subjects after oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation cefpodoxime proxetil dry suspension and the reference preparation cefpodoxime proxetil dry syrup in healthy subjects.

Start Date10 Jul 2024

Sponsor / Collaborator

Shijiazhuang No. 4 Pharmaceutical Co., Ltd.

CTR20242085 / CompletedNot Applicable

头孢泊肟酯片在空腹及餐后条件下的人体生物等效性试验

[Translation] Bioequivalence study of cefpodoxime proxetil tablets in humans under fasting and fed conditions

研究健康受试者在空腹及餐后条件下，单次口服由浙江巨泰药业有限公司生产的头孢泊肟酯片（受试制剂T，规格：100mg）与相同条件下单次口服由Daiichi Sankyo Co., Ltd.持证的头孢泊肟酯片（参比制剂R，商品名：BANAN®，规格：100mg）的药动学特征，评价两制剂的生物等效性及安全性。

[Translation]

To study the pharmacokinetic characteristics of a single oral administration of cefpodoxime proxetil tablets (test preparation T, strength: 100 mg) produced by Zhejiang Jutai Pharmaceutical Co., Ltd. under fasting and postprandial conditions in healthy subjects and a single oral administration of cefpodoxime proxetil tablets (reference preparation R, trade name: BANAN®, strength: 100 mg) certified by Daiichi Sankyo Co., Ltd. under the same conditions, and to evaluate the bioequivalence and safety of the two preparations.

Start Date24 Jun 2024

Sponsor / Collaborator

Zhejiang Jutai Pharmaceutical Co. Ltd.

100 Clinical Results associated with Cefpodoxime Proxetil

100 Translational Medicine associated with Cefpodoxime Proxetil

100 Patents (Medical) associated with Cefpodoxime Proxetil

912

Literatures (Medical) associated with Cefpodoxime Proxetil

01 Dec 2024·Molecular biology reports

High carriage of plasmid-mediated quinolone resistance (PMQR) genes by ESBL-producing and fluoroquinolone-resistant Escherichia coli recovered from animal waste dumps

Article

Author: Olowomofe, Temitayo Omotunde ; Akinlabi, Olabisi Comfort ; Olaposi, Adedolapo Victoria ; Adekanmbi, Abimbola Olumide ; Joel, Elizabeth Omokoshi

BACKGROUND:

There has been a rise in the consumption of fluoroquinolones in human and veterinary medicine recently. This has contributed to the rising incidence of quinolone resistance in bacteria. This study aimed at the determination of the antibiotic resistance profile of ESBL-producing and fluoroquinolone-resistant E. coli (FQEC) isolated from animal waste obtained from the waste dumps of an agricultural farm and their carriage of genes encoding PMQR.

METHODS AND RESULTS:

Isolation of ESBL-producing E. coli from animal waste samples was done on CHROMagar ESBL, while presumptive isolates were purified, and identified via the detection of uidA gene. Susceptibility to a panel of ten antibiotics was done using the disc diffusion method, and detection of PMQR genes (qnrA, qnrB, qnrS, aac(6')-lb-cr, qepA and oqxAB) was done using monoplex and duplex PCR. Twenty-five ESBL-producing and FQEC were obtained from the cattle (6), piggery (7) and poultry (12) waste dumps of the farm. There was 100% resistance to cefpodoxime, cefotaxime, enrofloxacin, trimethoprim-sulfamethoxazole and penicillin by the isolates. The resistance to the other antibiotics was streptomycin (48%), ceftazidime (24%), while no isolate resisted amoxicillin-clavulanate and imipenem. The frequencies of PMQR genes detected were; qnrA (96%), oqxAB (96%), qnrB (92%), while qnrS was detected in 88% (22) of the isolates. Aminoglycoside acetyltransferase (aac(6')-lb-cr) and quinolone efflux pump (qepA) were each detected in 20 (80%) of the isolates.

CONCLUSIONS:

This study showed that animal wastes disposed indiscriminately into dumps could be a budding 'hotspot' for multidrug resistant, ESBL-producing and fluoroquinolone-resistant E. coli carrying multiple genes encoding resistance to fluoroquinolone antibiotics.

01 Dec 2024·MICROBIAL PATHOGENESIS

Whole genome sequencing (WGS) analysis of antimicrobial resistance (AMR) milk and dairy-derived pathogens from Anand, Gujarat, India

Article

Author: Patel, Sandip ; Vahora, Shirin ; Sabara, Pritesh ; Patel, Arun ; Hati, Subrota ; Chauhan, Harshad ; Sharma, Kishan ; Shrimali, Mehul ; Panchal, Janki

This study aimed to evaluate the antimicrobial resistance (AMR) patterns and genomic characteristics of Enterococcus faecalis, Enterococcus faecium, and Staphylococcus aureus strains isolated from dairy products, including buttermilk, curd, ice cream, and sweets, in the Anand region of Gujarat, India. A total of 205 isolates were analysed, with the highest contamination levels found in buttermilk and curd. The bacterial isolates were identified using biochemical tests and advanced Matrix-Assisted Laser Desorption/Ionization Time-of-Flight (MALDI-TOF) mass spectrometry. Antimicrobial susceptibility testing (AST) was performed using the Kirby-Bauer disk diffusion method, following CLSI guidelines, focusing on common antibiotics used for treating dairy-related bacterial infections. Resistance profiles were analysed using WHONET software.s The findings revealed significant multidrug resistance (MDR), particularly among E. faecium and E. faecalis, with over 95 % resistance to key antibiotics, including linezolid, ciprofloxacin, cefpodoxime, and carbapenems. Many strains were classified as MDR, XDR, and PDR. Staphylococcus aureus also exhibited substantial resistance to penicillin and enrofloxacin. whole-genome sequencing (WGS) and phylogenetic analysis to identify AMR determinants and conduct nucleotide sequence alignment. The study identified several antibiotic resistance genes, including LiaF, which regulates the expression of LiaR and LiaS genes. WGS revealed that genes such as GdpD, MprF, and PgsA encode intrinsic resistance determinants, contributing to antibiotic resistance. Additional AMR mechanisms were identified, including ABC transporter efflux pumps and the regulation of resistance genes by LiaR and LiaS. Phylogenetic analysis indicates a close relationship between Enterococcus faecium 640 1352.18624 and Enterococcus durans FB129-CNAB-4 883162.3.

30 Oct 2024·JAC-Antimicrobial Resistance

AmpC β-lactamases detected in Southeast Asian Escherichia coli and Klebsiella pneumoniae

Article

Author: Cheav, Chanvoleak ; Watthanaworawit, Wanitda ; Ling, Clare L ; Silisouk, Joy ; Phommasone, Koukeo ; Ashley, Elizabeth A ; Hopkins, Jill ; Batty, Elizabeth M ; Sengduangphachanh, Amphonesavanh ; Roberts, Tamalee ; Turner, Paul

Abstract:

Objectives:

AmpC β-lactamases are neglected compared with ESBL as a cause of third-generation cephalosporin (3GC) resistance in Enterobacterales in low- and middle-income countries and the burden is unknown. The aim of this study was to investigate the presence of AmpC β-lactamase-producing Escherichia coli and Klebsiella pneumoniae in clinical specimens from three clinical research laboratories in Southeast Asia.

Methods:

Stored clinical isolates of E. coli and K. pneumoniae resistant to ceftriaxone or ceftazidime or cefpodoxime and ESBL confirmation test negative were screened using MASTDISCS AmpC, ESBL and Carbapenemase Detection Set—D72C. Short-read WGS was performed to identify ampC genes.

Results:

Of 126 isolates collected between 2010 and 2020, 31 (24.6%) and 16 (12.7%) were phenotypically AmpC and inducible AmpC positive by MASTDISCS testing, respectively. All inducible AmpC isolates were ceftriaxone susceptible and 97.7% of AmpC/inducible AmpC isolates tested against cefoxitin were resistant. Through WGS, 17 and eight different STs were detected for the AmpC/inducible AmpC E. coli and K. pneumoniae isolates, respectively. Twelve different β-lactamase resistance genes were detected, with blaCMY-2 most commonly in AmpC-positive isolates (20/31; 64.5%; 15 chromosomal, five plasmid). All inducible AmpC-positive isolates had the blaDHA-1 gene (seven chromosomal, nine plasmid).

Conclusions:

Though uncommon, AmpC and inducible AmpC β-lactamases in E. coli and K. pneumoniae are an important cause of infection in Southeast Asia. With current testing methods, these infections may be going undetected, resulting in patients receiving suboptimal treatment.

News (Medical) associated with Cefpodoxime Proxetil

18 Jun 2021

·www.biospace.com

Entasis Therapeutics Introduces First-in-Class Candidate, ETX0462, and Presents Data on SUL-DUR and ETX0282CPDP at World Microbe Forum

WALTHAM, Mass., June 18, 2021 (GLOBE NEWSWIRE) -- Entasis Therapeutics Holdings Inc. (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, today announced multiple presentations at the World Microbe Forum 2021, taking place virtually June 20-24. Entasis will present 11 posters with one oral presentation highlighting ETX0462, a novel, first-in-class, diazabicyclooctane with antimicrobial activity against Pseudomonas aeruginosa. Presentations will also include updates on SUL-DUR, a β-lactam/β-lactamase inhibitor currently in a Phase 3 registrational clinical trial to treat infections caused by carbapenem-resistant Acinetobacter baumannii, and ETX0282CPDP, an oral β-lactam/β-lactamase inhibitor being developed to treat multidrug-resistant Gram-negative pathogens, including those caused by extended-spectrum β-lactamases (ESBLs) and carbapenem-resistant Enterobacteriaceae (CRE). The details of the presentations are as follows: SUL-DUR Presentations: Poster: Outer membrane permeability and efflux do not limit antibacterial activity of sulbactam-durlobactam in Acinetobacter baumannii Session: AAR09 Pharmacological Studies of Investigational Agents Pre-NDA Poster Number: WMF21-0322 Poster: Effect of Susceptibility Testing Conditions on the In Vitro Antibacterial Activity of Sulbactam-Durlobactam Session: AAR09 Pharmacological Studies of Investigational Agents Pre-NDA Poster Number: WMF21-0325 Poster: Sulbactam-Durlobactam MIC and Disk Diffusion Quality Control Ranges Using a CLSI M23-A4 Study Design Session: AAR09 Pharmacological Studies of Investigational Agents Pre-NDA Poster Number: WMF21-0326 ETX0282CPDP Presentation: Poster: The β-lactamase inhibitor ETX1317 restores the activity of cefpodoxime against recent (2017-2019), geographically diverse drug-resistant Enterobacterales isolates Session: AAR08 New Antimicrobial Agents (in vitro and in vivo Studies Prior to the Start of Clinical Therapeutic Studies/pre-Phase 2) Poster Number: WMF21-0290 ETX0462 Presentations: Oral Presentation: The Discovery of the Novel Diazabicyclooctane (DBO) ETX0462: A Single Antibacterial Agent to Treat Gram-negative Infections, Including MDR Pseudomonas aeruginosa Session: AAR107 New Agents Discovery Summary Session: Early New Antimicrobial Agents Date and Time: Monday, June 21, 2021, 11:00am-12:30 pm Poster: ETX0462 Inhibits Penicillin-Binding Protein 3 of Pseudomonas aeruginosa and Escherichia coli Session: AAR08 New Antimicrobial Agents (in vitro and in vivo Studies Prior to the Start of Clinical Therapeutic Studies/pre-Phase 2) Poster Number: WMF21-0287 Poster: ETX0462 is a Novel PBP Inhibitor with Potent Activity against Recent, Global, Gram-Negative, Clinical Isolates Session: AAR08 New Antimicrobial Agents (in vitro and in vivo Studies Prior to the Start of Clinical Therapeutic Studies/pre-Phase 2) Poster Number: WMF21-0293 Poster: The Novel, Non-β-lactam PBP Inhibitor, ETX0462, Retains Potent Antibacterial Activity Across Isogenic Panels of Gram-negative Resistant Determinants Session: AAR08 New Antimicrobial Agents (in vitro and in vivo Studies Prior to the Start of Clinical Therapeutic Studies/pre-Phase 2) Poster Number: WMF21-0288 Poster: ETX0462, a Novel Non β-lactam PBP Inhibitor, Is Bactericidal Against Gram negative pathogens with a Low Propensity for Mutant Generation Session: AAR08 New Antimicrobial Agents (in vitro and in vivo Studies Prior to the Start of Clinical Therapeutic Studies/pre-Phase 2) Poster Number: WMF21-0286 Poster: Evaluation of the Pharmacokinetics/Pharmacodynamics (PK/PD) of the Novel Diazabicyclooctane (DBO) ETX0462 Against Pseudomonas aeruginosa Infections, Including MDR Strains Session: AAR07 Antimicrobial Pharmacokinetics and Pharmacodynamics Poster Number: WMF21-0292 Poster: The Novel, Non-β-lactam PBP Inhibitor, ETX0462, Has Potent Activity Against Biothreat Pathogens In Vitro and In Vivo Session: AAR08 New Antimicrobial Agents (in vitro and in vivo Studies Prior to the Start of Clinical Therapeutic Studies/pre-Phase 2) Date and Time: WMF21-0312 About Entasis Therapeutics Inc. Entasis is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel antibacterial products to treat serious infections caused by multidrug-resistant Gram-negative bacteria. Entasis’ pathogen-targeted design platform has produced a pipeline of product candidates, including SUL-DUR (targeting Acinetobacter baumannii infections), zoliflodacin (targeting Neisseria gonorrhoeae infections), ETX0282CPDP (targeting Enterobacteriaceae infections) and ETX0462 (targeting Pseudomonas infections). For more information, visit Company Contact Investor Contact Kyle Dow Bruce Mackle Entasis Therapeutics LifeSci Advisors (781) 810-0114 (929) 469-3859 kyle.dow@entasistx.com bmackle@lifesciadvisors.com

Small molecular drugFirst in Class

100 Deals associated with Cefpodoxime Proxetil

External Link

KEGG	Wiki	ATC	Drug Bank
D00920	Cefpodoxime Proxetil	J01DD13	DBSALT001354

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Gram-Negative Bacterial Infections	US	Pharmacia & Upjohn, Inc.	07 Aug 1992
Gram-Negative Bacterial Infections	US	Sankyo Corp.	07 Aug 1992
Gram-Positive Bacterial Infections	US	Pharmacia & Upjohn, Inc.	07 Aug 1992
Gram-Positive Bacterial Infections	US	Sankyo Corp.	07 Aug 1992
Bacterial Infections	JP	Daiichi Sankyo Co., Ltd.	29 Sep 1989

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03098485 (CTgov)	Not Applicable	Bacterial Infections	20	Levofloxacin (Levofloxacin)	jsmmpaxyhi(jezztbwlnd) = rvcnixswks pevueqhfov (vaqphkvzfu, kfzjpwtkdg - kwunbxuxaa) View more	-	10 Nov 2022
				Azithromycin (Azithromycin)	jsmmpaxyhi(jezztbwlnd) = jcmtsbnhvq pevueqhfov (vaqphkvzfu, dmezldrvxp - sgytlctsbz) View more
NCT00194532 (Pubmed \| JAMA)	Not Applicable	Cystitis	300	Cefpodoxime	bsdbanjwcp(mrpeuzutrg) = sfymhibmlj kbspirfklc (knsvdzxrbs ) View more	Negative	08 Feb 2012
				Ciprofloxacin	bsdbanjwcp(mrpeuzutrg) = jcnjdstgnh kbspirfklc (knsvdzxrbs ) View more
NCT00194532 (CTgov)	Not Applicable	Urinary Tract Infections \| Acute cystitis	300	Ciprofloxacin (Ciprofloxacin)	bflmvievmn(wdfftqogpf) = clyjhooyhn hozlljhgjj (jhclqtcqut, uosaetuslb - dwnshggcjw) View more	-	28 Apr 2011
				Cefpodoxime (Cefpodoxime)	bflmvievmn(wdfftqogpf) = tkkywfqluy hozlljhgjj (jhclqtcqut, ixknoiyzli - qzgboefmlt) View more

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