主要目的：在健康受试者中，评价Pfizer Japan Inc.持证的参比制剂盐酸米诺环素胶囊（MINOMYCIN，50 mg （按C23H27N3O7计））与浙江华海制药科技有限公司生产的受试制剂盐酸米诺环素胶囊（50 mg（按C23H27N3O7计））在空腹和餐后条件下的生物等效性。次要目的：观察受试制剂盐酸米诺环素胶囊与参比制剂盐酸米诺环素胶囊（MINOMYCIN）在健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the reference preparation minocycline hydrochloride capsules (MINOMYCIN, 50 mg (calculated as C23H27N3O7)) certified by Pfizer Japan Inc. and the test preparation minocycline hydrochloride capsules (50 mg (calculated as C23H27N3O7)) produced by Zhejiang Huahai Pharmaceutical Technology Co., Ltd. under fasting and fed conditions in healthy subjects. Secondary objective: To observe the safety of the test preparation minocycline hydrochloride capsules and the reference preparation minocycline hydrochloride capsules (MINOMYCIN) in healthy subjects.

Start Date02 Aug 2024

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Technology Co., Ltd.

CTR20241134 / CompletedNot Applicable

盐酸米诺环素胶囊在健康受试者中单中心、随机、开放、单剂量、两制剂、两周期、两序列交叉设计在空腹给药和餐后给药两种状态下人体生物等效性研究

[Translation] A single-center, randomized, open-label, single-dose, two-formulation, two-period, two-sequence crossover design of minocycline hydrochloride capsules in healthy subjects under fasting and fed conditions

本试验旨在研究单次空腹和餐后口服安徽省先锋制药有限公司研制、生产的盐酸米诺环素胶囊（100 mg）的药代动力学特征；以Pfizer Japan Inc.持证、ファイザ一株式会社生产的盐酸米诺环素胶囊（MINOMYCIN®，100 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

This study aimed to investigate the pharmacokinetic characteristics of minocycline hydrochloride capsules (100 mg) developed and produced by Anhui Pioneer Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; minocycline hydrochloride capsules (MINOMYCIN®, 100 mg) licensed by Pfizer Japan Inc. and produced by ファイザ一 Co., Ltd. were used as the reference preparation, and the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared to evaluate the bioequivalence of the two preparations in humans.

Start Date01 May 2024

Sponsor / Collaborator

Anhui Pioneer Pharmaceutical Co. Ltd.

CTR20241412 / CompletedNot Applicable

评估受试制剂交沙霉素片（规格：50 mg）与参比制剂交沙霉素片（规格：50 mg）在健康成年受试者空腹和餐后状态下的单中心、开放、随机、单剂量、四周期、两序列、完全重复交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, four-period, two-sequence, fully repeated crossover bioequivalence study was conducted to evaluate the bioequivalence of the test preparation josamycin tablets (strength: 50 mg) and the reference preparation josamycin tablets (strength: 50 mg) in healthy adult subjects in the fasting and fed state.

主要研究目的：研究空腹和餐后状态下单次给药受试制剂交沙霉素片（规格：50 mg，持证商：桂林南药股份有限公司）与参比制剂交沙霉素片（规格：50 mg，持证商：Astellas Pharma Inc./ LTL ファーマ株式会社）在健康受试者体内的药代动力学，评价空腹和餐后状态口服两种制剂的生物等效性。次要研究目的：评估受试制剂交沙霉素片（规格：50 mg）和参比制剂交沙霉素片（规格：50 mg）在健康受试者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetics of the test preparation josamycin tablets (specification: 50 mg, licensee: Guilin Nanyao Co., Ltd.) and the reference preparation josamycin tablets (specification: 50 mg, licensee: Astellas Pharma Inc./ LTL ファーマ株式会社) in healthy subjects after single administration in the fasting and fed state, and to evaluate the bioequivalence of the two preparations in the fasting and fed state. The secondary purpose of the study is to evaluate the safety of the test preparation josamycin tablets (specification: 50 mg) and the reference preparation josamycin tablets (specification: 50 mg) in healthy subjects.

Start Date27 Apr 2024

Sponsor / Collaborator

Guilin Pharmaceutical Co., Ltd.

100 Clinical Results associated with Infectious enteritis

100 Translational Medicine associated with Infectious enteritis

0 Patents (Medical) associated with Infectious enteritis

442

Literatures (Medical) associated with Infectious enteritis

01 Sep 2024·The American Journal of the Medical Sciences

Cryptosporidium-induced acute kidney injury in the setting of acquired immunodeficiency syndrome

Review

Author: Chou, Yi-Hsin ; Fan, Hung-Ju

Cryptosporidium is a pathogen that can cause infectious enteritis especially in immunocompromised patients. Acute kidney injury, electrolyte imbalance, and acid-base disorders may occur as a result of high volumes of intestinal fluid loss, which has not been previously reported to be a common manifestation of cryptosporidiosis. Numerous antigen detection methods can be used to ensure early diagnosis of Cryptosporidium infection, which is crucial to prevent morbidities. We report a unique case of cryptosporidiosis in a 33-year-old male patient with acute kidney injury and profound hypokalemia, hyponatremia, hypocalcemia, hypophosphatemia, hypomagnesemia, and metabolic acidosis. Following the initiation of antiretroviral therapy to human immunodeficiency virus, the patient's symptoms improved and he recovered fully from kidney injury and electrolyte imbalance, highlighting the importance of early antiretroviral therapy.

01 Sep 2024·Journal of Virological Methods

Diagnosing viral gastro-enteritis using the fully automated sample-in, result-out STARlet All in one system (AIOS)

Article

Author: Nijhuis, Roel H T ; Smits, Paul H M ; Heijne-Tol, Anja ; Russcher, Anne ; Verhees, Fabienne B ; Rezek, Youssef ; Sterk, Luuk ; Claas, Eric C J

The STARlet All-In-One system is a modular platform that integrates the complete molecular diagnostic workflow from nucleic acid extraction of clinical samples to PCR set-up and amplification. The platform was evaluated in comparison with laboratory developed tests (LDT) on fecal samples from patients with suspected viral gastro-enteritis. In a retrospective study, 72 positive samples were analysed, including all pathogens detected by the Seegene Allplex™ GI-virus assay, adenovirus, astrovirus, norovirus GI and GII, sapovirus, and rotavirus. Concordant results were obtained for 69 samples (96 %). Three discordant results were observed, one norovirus GII positive that gave an invalid result in the AIOS and two samples that were negative in the AIOS. One adenovirus positive that was subtyped as a genotype 2 virus, which is not associated with gastro-enteritis, and a sapovirus. In the prospective part of the study, 661 fecal samples were included. A total of 61 positive samples were detected, of which 60 were also detected by the AIOS. One norovirus GII positive sample (C_T 35.2) was tested negative in the AIOS. Two additional sapovirus positive samples, C_T 37 and 38, were detected by the AIOS but not by the LDT. The STARlet All-In-One platforms results in an automated molecular workflow with reduced hands-on time and enables running assays during out of office hours. Application of the Seegene Allplex™ GI-virus assay showed excellent concordance to the current diagnostic LDT. In a prospective comparison, only three discordant results were observed, all with C_T values over 35 and therefore unlikely of clinical relevance.

13 Aug 2024·Proceedings of the National Academy of Sciences

Lining the small intestine with mycobacteriophages protects from Mycobacterium avium subsp. paratuberculosis and eliminates fecal shedding

Article

Author: De Buck, Jeroen ; Harman-McKenna, Victoria K. ; Shafer, Natali ; Eshraghisamani, Razieh

Johne’s disease (JD), a chronic, infectious enteritis caused by Mycobacterium avium subsp. paratuberculosis (MAP), affects wild and domestic ruminants. There is no cure or effective prevention, and current vaccines have substantial limitations, leaving this disease widespread in all substantial dairy industries causing economic, and animal welfare implications. Mycobacteriophages (MPs) have been gaining interest in recent years and are proposed as a promising solution to curtailing MAP infection. Using a well-validated infection model, we have demonstrated the preventative potential of MPs to protect dairy calves against MAP infection. Calves were supplemented daily with a phage cocktail from birth till weaning at 2 m of age and inoculated with MAP at 2 wk of age. Infection status was measured for 4.5 mo through blood, fecal, and postmortem tissue samples. Our findings highlight the remarkable efficacy of orally administered MPs. Notably, fecal shedding of MAP was entirely eliminated within 10 wk, in contrast to the infected control group where shedding continued for the entirety of the trial period. Postmortem tissue culture analysis further supported the effectiveness of MPs, with only 1 out of 6 animals in the phage-treated group testing positive for MAP colonized tissues compared to 6 out of 6 animals in the infected control group. Additionally, plaque assay results demonstrated the ability of phages to persist within the intestinal tract. Collectively, these results underscore the potential of orally administered MP cocktails as a highly effective intervention strategy to combat JD in dairy calves and by extension in the dairy industry.

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