[Translation] A single-center, open-label, randomized, single-dose, three-period, three-sequence, partially repeated crossover bioequivalence study to evaluate the test preparation azithromycin dry suspension and the reference preparation azithromycin dry suspension (Zithromax®) in healthy adult subjects in the fasting/fed state

以辉瑞制药有限公司持证的阿奇霉素干混悬剂（商品名：希舒美®）为参比制剂，以海南全星制药有限公司生产的阿奇霉素干混悬剂为受试制剂，通过单中心、开放、随机、单剂量、三周期、三序列、部分重复交叉临床研究来评价两种制剂的人体生物等效性。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

The azithromycin dry suspension (trade name: Xishumei®) certified by Pfizer Pharmaceuticals Co., Ltd. was used as the reference preparation, and the azithromycin dry suspension produced by Hainan Quanxing Pharmaceutical Co., Ltd. was used as the test preparation. The human bioequivalence of the two preparations was evaluated through a single-center, open, randomized, single-dose, three-cycle, three-sequence, partially repeated crossover clinical study. Secondary study purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date29 Jul 2024

Sponsor / Collaborator

Hainan Quanxing Pharmaceutical Co. Ltd.

CTR20221540 / CompletedNot Applicable

头孢丙烯干混悬剂在空腹及餐后条件下的人体生物等效性试验

[Translation] Bioequivalence study of cefprozil dry suspension in humans under fasting and fed conditions

本研究考察健康受试者在空腹及餐后条件下，单次口服由广东恒健制药有限公司生产的头孢丙烯干混悬剂【受试制剂，规格：0.125 g（按 C18H19N3O5S 计）】或由 Lupin Pharmaceuticals,Inc.生产（Lupin LTD 持证）的头孢丙烯干混悬剂【参比制剂，商品名：Cefprozil®，规格：0.125g/5ml（按 C18H19N3O5S 计）】的药动学特征，评价两制剂的生物等效性及安全性，为该受试制剂注册申请提供依据。

[Translation]

This study investigated the pharmacokinetic characteristics of a single oral dose of cefprozil dry suspension produced by Guangdong Hengjian Pharmaceutical Co., Ltd. [test preparation, specification: 0.125 g (calculated as C18H19N3O5S)] or cefprozil dry suspension produced by Lupin Pharmaceuticals, Inc. (licensed by Lupin LTD) [reference preparation, trade name: Cefprozil®, specification: 0.125 g/5 ml (calculated as C18H19N3O5S)] in healthy subjects under fasting and postprandial conditions, evaluated the bioequivalence and safety of the two preparations, and provided a basis for the registration application of the test preparation.

Start Date03 Aug 2022

Sponsor / Collaborator

Jiangmen Hengjian Pharmaceutical Co. Ltd.

CTR20221535 / CompletedNot Applicable

阿奇霉素干混悬剂在中国健康受试者中进行的单中心、随机、开放、单次（空腹/餐后）口服给药、两制剂、三序列、三周期部分重复交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose (fasting/fed) oral bioequivalence study of azithromycin dry suspension in healthy Chinese subjects with two preparations, three sequences, and three periods with partial repeated crossover

主要目的：观察中国健康受试者在空腹/餐后状态下单次口服受试制剂阿奇霉素干混悬剂（规格：0.1g；生产企业：瑞阳制药股份有限公司）和参比制剂阿奇霉素干混悬剂（商品名：希舒美®；规格：0.1g；持证商：辉瑞制药有限公司）后的药代动力学特征，评价空腹/餐后状态下两种制剂的生物等效性。次要目的：观察受试制剂阿奇霉素干混悬剂和参比制剂阿奇霉素干混悬剂（希舒美®）在中国健康受试者中的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation azithromycin suspension (specification: 0.1g; manufacturer: Ruiyang Pharmaceutical Co., Ltd.) and the reference preparation azithromycin suspension (trade name: Xishumei®; specification: 0.1g; licensee: Pfizer Pharmaceuticals Co., Ltd.) after a single oral administration in the fasting/postprandial state in healthy Chinese subjects, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation azithromycin suspension and the reference preparation azithromycin suspension (Xishumei®) in healthy Chinese subjects.

Start Date05 Jul 2022

Sponsor / Collaborator

Ruiyang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Non-complicated skin and skin structure infection

100 Translational Medicine associated with Non-complicated skin and skin structure infection

0 Patents (Medical) associated with Non-complicated skin and skin structure infection

130

Literatures (Medical) associated with Non-complicated skin and skin structure infection

01 Nov 2024·Recent Advances in Anti-Infective Drug Discovery

Formulation and Optimization of Solid Lipid Nanoparticle-based Gel for Dermal Delivery of Linezolid using Taguchi Design

Article

Author: Chauhan, Iti ; Singh, Lubhan

Background:Linezolid (LNZ) is a synthetic oxazolidinone antibiotic approved for the treatment of uncomplicated and complicated skin and soft tissue infections caused by gram-positive bacteria. Typically, LNZ is administered orally or intravenously in most cases. However, prolonged therapy is associated with various side effects and lifethreatening complications. Cutaneous application of LNZ will assist in reducing the dose, hence minimizing the unwanted side/adverse effects associated with oral administration. Dermal delivery provides an alternative route of administration, facilitating a local and sustained concentration of the antimicrobial at the site of infection.Objective:The current research work aimed to formulate solid lipid nanoparticles (SLNs) based gel for dermal delivery of LNZ in the management of uncomplicated skin and soft tissue infections to maximise its benefits and minimise the side effects.Methods::SLNs were prepared by high-shear homogenisation and ultrasound method using Dynasan 114 as solid lipid and Pluronic F-68 as surfactant. The effect of surfactant concentration, drug-to-lipid ratio, and sonication time was investigated on particle size, zeta potential, and entrapment efficiency using the Taguchi design. The main effect plot of means and signal-to-noise ratio were generated to determine the optimized formulation. The optimized batch was formulated into a gel, and ex-vivo permeation study, in-vitro and in-vivo antibacterial activity were conducted.Results:The optimised process parameters to achieve results were 2% surfactant concentration, a drug-to-lipid ratio of 1:2, and 360 s of sonication time. The optimized batch was 206.3± 0.17nm in size with a surface charge of -24.4± 4.67mV and entrapment efficiency of 80.90 ± 0.45%. SLN-based gel demonstrated anomalous transport with an 85.43% in vitro drug release. The gel showed a 5.03 ± 0.15 cm zone of inhibition while evaluated for in vitro antibacterial activity against Staphylococcus aureus. Ex-vivo skin permeation studies demonstrated 20.308% drug permeation and 54.96% cutaneous deposition. In-vivo results showed a significant reduction in colony-forming units in the group treated with LNZ SLN-based gel.Conclusion:Ex-vivo studies ascertain the presence of the drug at the desired site and improve therapy. In-vivo results demonstrated the ability of SLN-based gel to significantly reduce the number of bacteria in the stripped infection model. The utilization of SLN as an LNZ carrier holds significant promise in dermal delivery.

01 Jan 2024·Therapeutic Advances in Infectious Disease

Short-term versus usual-term antibiotic treatment for uncomplicated Staphylococcus aureus bacteremia: a systematic review and meta-analysis

Review

Author: Garzon Herazo, Javier Ricardo ; Muñoz Velandia, Oscar Mauricio ; Grillo Perez, Santiago ; Diaz-Brochero, Candida

Introduction: Uncomplicated Staphylococcus aureus bacteremia remains a leading cause of morbidity and mortality in hospitalized patients. Current guidelines recommend a minimum of 14 days of treatment. Objective: To evaluate the efficacy and safety of short versus usual antibiotic therapy in adults with uncomplicated S. aureus bacteremia (SAB). Methods: We developed a search strategy to identify systematic review and meta-analysis of non-randomized studies (NRS), comparing short versus usual or long antibiotic regimens for uncomplicated SAB in MEDLINE, Embase, and the Cochrane Register up to June 2023. The risk of bias was assessed using the ROBINS I tool. The meta-analysis was performed using Review Manager software with a random effect model. Results: Six NRS with a total of 1700 patients were included. No significant differences were found when comparing short versus prolonged antibiotic therapy as defined by the authors for 90-day mortality [odds ratio (OR): 1.09; 95% confidence interval (CI): 0.82–1.46, p: 0.55; I2 = 0%] or 90-day recurrence or relapse of bacteremia [OR: 0.72; 95% CI: 0.31–1.68, p: 0.45; I2 = 26%]. Sensitivity analysis showed similar results when comparing a predefined duration of <14 days versus ⩾14 days and when excluding the only study with a high risk of bias. Conclusion: Shorter-duration regimens could be considered as an alternative option for uncomplicated SAB in low-risk cases. However, based on a small number of studies with significant methodological limitations and risk of bias, the benefits and harms of shorter regimens should be analyzed with caution. Randomized clinical trials are needed to determine the best approach regarding the optimal duration of therapy.

01 Feb 2023·European Journal of Clinical Microbiology & Infectious Diseases

TIVAP-related infection due to Gram-negative aerobic bacilli: should TIVAP stay or should it go?

Article

Author: Rolland, Simon ; Mainardi, Jean-Luc ; Kassis-Chikhani, Najiby ; Bidaud, Anne-Laure ; Auclin, Edouard ; Bensaid, Samuel ; Lebeaux, David ; Blez, Damien ; Gerlinger, Marie-Paule ; Dubert, Marie

We aimed to describe the outcome of totally implantable venous-access port (TIVAP)-related infections due to Gram-negative aerobic bacilli (Pseudomonas aeruginosa and other Pseudomonas spp., Acinetobacter spp., and Stenotrophomonas maltophilia), or GNAB, and assess the safety of conservative treatment. We conducted a retrospective study in a French teaching hospital, from January 2016 to December 2020, including adult patients treated for TIVAP-related infection due to GNAB. Success of conservative treatment was defined as a functional TIVAP 3 months after infection with no recurrence. We performed a bivariate analysis and analyzed causes for treatment failure. We included 68 patients (53 TIVAP-related bloodstream infections, 11 TIVAP-related infections, and 4 probable TIVAP-related infections) due to GNAB, mostly P. aeruginosa (50/68, 74%). TIVAP removal was initially decided for 49/68 patients (72%). Among the 19/68 (28%) patients with conservative treatment (all for infections caused by P. aeruginosa), 5/19 (26%) had successful treatment, 7/19 (37%) experienced failure (without sepsis or septic shock), 6/19 (32%) died within 3 months without TIVAP removal and no signs of infection recurrence, and 1 patient had TIVAP removal as it was no longer required. TIVAP-related infections caused by GNAB frequently require TIVAP removal. Conservative treatment can be performed in selected patients with a non-complicated infection caused by P. aeruginosa, who can benefit from the continuation of antineoplastic chemotherapy or palliative care. Treatment failures were not associated with sepsis or septic shock.

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