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 Date15 Apr 2025

Sponsor / Collaborator

The General Hospital Corp.

[+1]

CTR20244510

/ CompletedNot Applicable

头孢泊肟酯干混悬剂人体生物等效性研究

[Translation] Study on the bioequivalence of cefpodoxime proxetil dry suspension in healthy volunteers

是以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定头孢泊肟酯干混悬剂受试制剂给药后血浆中的头孢泊肟在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以第一三共株式会社持证生产的头孢泊肟酯干糖浆【商品名：Banan®，规格：50mg/g，100g/瓶】为参比，评价制剂间的生物等效性，并观察头孢泊肟酯干混悬剂在中国健康受试者中的安全性。

[Translation]

Chinese healthy subjects were used as test subjects. A self-cross-controlled experimental design was adopted to determine the time course of cefpodoxime plasma concentration in healthy subjects after administration of the test formulation of cefpodoxime proxetil dry suspension, estimate the corresponding pharmacokinetic parameters, and use the cefpodoxime proxetil dry syrup [trade name: Banan®, specification: 50 mg/g, 100 g/bottle] certified by Daiichi Sankyo Co., Ltd. as a reference to evaluate the bioequivalence between the preparations and observe the safety of cefpodoxime proxetil dry suspension in Chinese healthy subjects.

Start Date24 Dec 2024

Sponsor / Collaborator

Hainan Huluwa Pharmaceutical Group Co., Ltd.

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.

100 Clinical Results associated with Cefpodoxime Proxetil

100 Translational Medicine associated with Cefpodoxime Proxetil

100 Patents (Medical) associated with Cefpodoxime Proxetil

1,379

Literatures (Medical) associated with Cefpodoxime Proxetil

01 Mar 2025·Journal of Applied Spectroscopy

Development and Validation of the Colorimetric Charge Transfer Complex for Estimation of Cefpodoxime Proxetil in Bulk and Pharmaceutical Preparations

Author: Karasakal, Ayca ; Ozdemir, Elif

Cefpodoxime proxetil (CFP) is a third-generation cephalosporins group antibiotic which is an antibacterial beta-lactam agent that is used in the treatment of acute otitis, pharyngitis, tonsillitis and lower respiratory tract infections (e.g. pinomonia and bronchitis).A simple, fast and sensitive spectrophotometric method was developed for the determination of cefpodoxime proxetile in bulk and pharmaceutical preparationsThe proposed method was based on the charge transfer interactions of cefpodoxime proxetil as n-electron donor with 7,7,8,8-tetracyan oquinodimethane (TCNQ) as the π-acceptor.In addition, the described method was validated in accordance with the requirements of ICH guidelines.The absorbance was measured at 596 nm.The parameter of linearity, LOD, LOQ, accuracy, precision and recovery were also evaluated.The assay was linear over the concentration range of 3.0-15.0 μg/mL.The correlation coefficient was obtained 0.9997 for CFP.LOD and LOQ values were found to be 0.036 and 0.108 μg/mL, resp.Recovery values were obtained ranging from 99.97 to 101.3% according to the standard addition method.The performance of the proposed method was evaluated in terms of the student′s t-test and variance ratio F-test to find out the significance of the proposed methods over the reference spectrophotometric method.The developed method was successfully applied for estimation of CFP in a pure form and as a pharmaceutical preparate.

13 Feb 2025·Antimicrobial Agents and Chemotherapy

How accurate is ceftriaxone at predicting susceptibility of enterobacterales isolates to oral higher-generation cephalosporins?

Article

Author: Tekle, Tsigereda ; Harris, Anthony D. ; Cosgrove, Sara E. ; Jacobs, Emily ; Claeys, Kimberly C. ; Tamma, Pranita D. ; Simner, Patricia J.

ABSTRACT The reliability of ceftriaxone for inferring susceptibility to higher-generation oral cephalosporins is unknown. Overall, ceftriaxone susceptibility predicted susceptibility to cefuroxime (89%), cefdinir (86%), cefpodoxime (90%), and cefixime (94%) based on disk diffusion results for 409 consecutive Enterobacterales bloodstream isolates from unique patients. Susceptibility percentages to the four oral cephalosporins ranged from 92% to 99% when limited to Escherichia coli , Klebsiella pneumoniae, Klebsiella oxytoca, or Proteus mirabilis isolates susceptible to ceftriaxone.

31 Jan 2025·Open Forum Infectious Diseases

Shigellosis in an Urban Slum in Kenya: Risk Factors and Antimicrobial Resistance

Article

Author: Haile, Kassa ; Khanam, Farhana ; Aziz, Asma Binte ; Firoj, Md Golam ; Rickett, Natasha Y ; Akter, Afroza ; Ara, Sadia Isfat ; Ahmmed, Faisal ; Chowdhury, Fahima ; Nasrin, Dilruba ; Zaman, K ; Kariuki, Samuel ; Park, Se Eun ; Mbae, Cecilia Kathure ; Ongadi, Beatrice Atieno ; Bundi, Martin Mwebia ; Khan, Ashraful Islam ; Kanungo, Suman ; Agampodi, Suneth ; Islam, Md Taufiqul ; Ngugi, Benjamin ; Im, Justin ; Clemens, John D ; Qadri, Firdausi ; Behute, Meseret Gebre ; Kering, Kelvin ; Mwangi, Moses

AbstractBackgroundShigella spp are among the notable causes of global diarrheal disease and death, accounting for 13.2% of deaths in 2016. Antimicrobial resistance complicates shigellosis management. Understanding local disease epidemiology is crucial for developing effective preventive strategies, including vaccine use.MethodsWe investigated antimicrobial resistance, risk factors (socioeconomic, behavioral, and water, sanitation and hygiene (WaSH), and clinical characteristics of Shigella diarrhea in Mukuru informal settlement and surrounding villages in Nairobi, Kenya. Patients presenting with diarrhea, fever, or both in treatment centers had stool or rectal swab samples cultured, and bacteria was identified through biochemical and serologic tests.ResultsThe rate of Shigella isolation among the 4689 individuals presenting with diarrhea was 1.4% across all ages, with a similar isolation rate (1.5%) among children <5 years of age. The majority of the Shigella spp (40 [59.7%]) were Shigella flexneri, and the majority of S flexneri (34 of 40 [85%]) were resistant to trimethoprim-sulfamethoxazole; however, all were sensitive to amoxicillin-clavulanate, ceftazidime, ceftriaxone, and cefpodoxime. The rate of multidrug resistance was higher in Shigella sonnei (13 [48.1%]) than in S flexneri (3 [7.5%]). Shigella positivity was associated with bloody diarrhea, severe/moderate dehydration, coated tongue, and high fever. Consumption of street food was also associated with Shigella diarrhea.ConclusionsDespite low prevalence, shigellosis still poses a significant burden of diarrheal disease, warranting future incidence studies. First-line antibiotics against Shigella remain effective, but intermediate resistance to azithromycin and ciprofloxacin is a concerning trend. Improving household food preparation and handling could potentially reduce Shigella infections.

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
Bacterial Infections	Japan	Daiichi Sankyo Co., Ltd.	29 Sep 1989

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03098485 (CTgov)	Not Applicable	Bacterial Infections	20	Levofloxacin (Levofloxacin)	fxttpnbtei(vrianypduz) = wjehntrbki hcczzxxdxb (thnbtqszdc, teogoldvdn - xpbzcbnpkl) View more	-	10 Nov 2022
				Azithromycin (Azithromycin)	fxttpnbtei(vrianypduz) = trsvnyxgvh hcczzxxdxb (thnbtqszdc, ckbtaltuud - hbslkhvusk) View more
Tandem Meetings ASTCT and CIBMTR2015	Not Applicable	Hematopoietic stem cell transplantation	80	Levofloxacin	mhjygswory(ahzchoazre) = kgrvsvrbft pijzguvgpq (ngclnpxjsm ) View more	Positive	01 Feb 2015
				Cefpodoxime	mhjygswory(ahzchoazre) = nktlopgtbt pijzguvgpq (ngclnpxjsm ) View more
NCT00194532 (Pubmed \| JAMA)	Not Applicable	Cystitis	300	Cefpodoxime	jxwlrksobn(ofxqnpdooo) = lsxilyuvzf nauzeadfaa (bogbwqsprt ) View more	Negative	08 Feb 2012
				Ciprofloxacin	jxwlrksobn(ofxqnpdooo) = quhofyaqiy nauzeadfaa (bogbwqsprt ) View more
NCT00194532 (CTgov)	Not Applicable	Urinary Tract Infections \| Cystitis	300	Ciprofloxacin (Ciprofloxacin)	knavganheb(qmjuquuwsa) = fadiswiira ompszywvzk (fvpbqjohxv, vocguokghj - irtanvmmmt) View more	-	28 Apr 2011
				Cefpodoxime (Cefpodoxime)	knavganheb(qmjuquuwsa) = lonumxynhl ompszywvzk (fvpbqjohxv, nnfvtbjyae - mjkotmkafm) View more

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