[Translation] A clinical trial to evaluate the safety and efficacy of cefuroxime sodium and sulbactam sodium for injection (2:1) in the treatment of moderate to severe acute bacterial infections of the urinary system

以注射用头孢哌酮钠舒巴坦钠（2:1）为阳性对照，评价注射用头孢呋辛钠舒巴坦钠（2:1）治疗中、重度泌尿系统急性细菌性感染的安全性、有效性（多中心、随机、盲法）。主要目的研究头孢呋辛钠舒巴坦钠治疗敏感细菌感染性疾病非劣于对照药。

[Translation]

To evaluate the safety and efficacy of cefuroxime sodium and sulbactam sodium for injection (2:1) in the treatment of moderate to severe acute bacterial infections of the urinary system (multicenter, randomized, blinded method), using cefuroxime sodium and sulbactam sodium for injection (2:1) as positive control. The main objective is to study the non-inferiority of cefuroxime sodium and sulbactam sodium to the control drug in the treatment of sensitive bacterial infections.

Start Date09 Apr 2013

Sponsor / Collaborator

Shenzhen Salubris Pharmaceuticals Co., Ltd.

CTR20131516 / CompletedPhase 3

评价注射用头孢呋辛钠舒巴坦钠（2:1）治疗中、重度下呼吸道急性细菌性感染的安全性、有效性临床试验

以注射用头孢哌酮钠舒巴坦钠（2:1）为阳性对照，评价注射用头孢呋辛钠舒巴坦钠（2:1）治疗中、重度下呼吸道急性细菌性感染的安全性、有效性（多中心、随机、盲法）。主要目的研究头孢呋辛钠舒巴坦钠治疗敏感细菌感染性疾病非劣于对照药。

[Translation]

To evaluate the safety and efficacy of cefuroxime sodium and sulbactam sodium for injection (2:1) in the treatment of moderate to severe acute bacterial infections of the lower respiratory tract (multicenter, randomized, blinded) using cefoperazone sodium and sulbactam sodium for injection (2:1) as positive control. The main objective is to study the non-inferiority of cefuroxime sodium and sulbactam sodium to the control drug in the treatment of sensitive bacterial infections.

Start Date28 Feb 2013

Sponsor / Collaborator

Shenzhen Salubris Pharmaceuticals Co., Ltd.

NCT01426191 / CompletedNot Applicable

A Open Multi-center Clinical Study on Cefotaxime Sodium and Sulbactam Sodium for Injection(2:1) for Treatment of Respiratory and Urinary Tract Infection

In the proposed study, the investigators plan to evaluate the efficacy and safety of Cefotaxime sodium and sulbactam sodium for injection (2:1)for the treatment of respiratory and urinary tract acute bacterial infection under the widely used in clinical conditions.

Start Date01 Aug 2011

Sponsor / Collaborator

Xiangbei Welman Pharmaceutical Co., Ltd.

100 Clinical Results associated with Cefotaxime Sodium/Sulbactam sodium

100 Translational Medicine associated with Cefotaxime Sodium/Sulbactam sodium

100 Patents (Medical) associated with Cefotaxime Sodium/Sulbactam sodium

Literatures (Medical) associated with Cefotaxime Sodium/Sulbactam sodium

01 Sep 2022·Journal of Global Antimicrobial Resistance

Co-existence of two ciprofloxacin-resistant Salmonella enterica serovar Kentucky strains in the urine of a bladder cancer patient

Letter

Author: Li, Qiuchun ; Zhang, Weibing ; Xu, Haiyan ; Cao, Xiaoli

In the present study, we isolated two Salmonella enterica serovar Kentucky (S. Kentucky) isolates from a 67-yr-old female patient diagnosed with bladder cancer because of blood in her urine in 2022.This thus raises the difficulty to eradicate the Salmonella infection in the patient using the cefotaxime sulbactam sodium and ciprofloxacin.In conclusion, this study is the first report of clin. MDR S. Kentucky strains evolving during the treatment of antimicrobial agents in a bladder cancer patient.

Frontiers in Immunology

Case Report: First Case of Cefotaxime-Sulbactam-Induced Acute Intravascular Hemolysis in a Newborn With ABO Blood Type Incompatibility by the Mechanism of Non-Immunologic Protein Adsorption

Author: Xiong, Fu ; Wu, Yuanjun ; Chen, Baochan ; Guo, Ganping ; Li, Jianqun ; Wu, Yong ; Yang, Yong

BackgroundABO blood type incompatibility hemolytic disease of newborn (ABO-HDN) and drug-induced immune hemolytic anemia (DIIHA) due to non-immunologic protein adsorption (NIPA) mainly cause extravascular hemolysis. All the reported severe DIIHA were caused by drug-induced antibodies, and rare report of acute intravascular hemolysis was caused by the NIPA mechanism or ABO-HDN.Case presentationWe report the first case of acute intravascular hemolysis induced by cefotaxime sodium - sulbactam sodium (CTX - SBT) in a case of ABO-HDN which resulted in death at 55 h after birth. The mother’s blood type was O and RhD-positive, and the newborn’s blood type was B and RhD-positive. No irregular red blood cell (RBC) antibodies or drug-dependent antibodies related to CTX or SBT was detected in the mother’s plasma and the plasma or the RBC acid eluent of the newborn. Before the newborn received CTX - SBT treatment, the result of direct antiglobulin test (DAT) was negative while anti-B was positive (2 +) in both plasma and acid eluent. After the newborn received CTX - SBT treatment, the results of DAT for anti-IgG and anti-C3d were both positive, while anti-B was not detected in plasma, but stronger anti-B (3 +) was detected in acid eluent. In vitro experiments confirmed that NIPA of SBT promoted the specific binding of maternal-derived IgG anti-B to B antigen on RBCs of the newborn, thereby inducing acute intravascular hemolysis.ConclusionThe NIPA effect of SBT promoted the specific binding of mother-derived IgG anti-B in newborn’s plasma to the newborn’s RBC B antigens and formed an immune complex, and then activated complement, which led to acute intravascular hemolysis. Drugs such as SBT with NIPA effect should not be used for newborns with HDN.

100 Deals associated with Cefotaxime Sodium/Sulbactam sodium

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Intraabdominal Infections	CN	-	-
Meningitis	CN	-	-
Reproductive Tract Infections	CN	-	-
Respiratory Tract Infections	CN	-	-
Urinary Tract Infections	CN	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute urinary tract infection	Phase 2	CN	Shenzhen Salubris Pharmaceuticals Co., Ltd.	09 Apr 2013
Bacterial respiratory infection	Phase 2	CN	Shenzhen Salubris Pharmaceuticals Co., Ltd.	28 Feb 2013

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