Pfizer's ZAVICEFTA (Ceftazidime-Avibactam) Approved in China for cIAI in Children Aged 3 Months and Older

BeijingOctober 10, 2022PR Newswire -- The new antibiotic ZAVICEFTA (Ceftazidime Avibactam Sodium for Injection 2.5g) has been approved by the National Medical Products Administration for the treatment of children aged 3 months and above with complicated intra-abdominal infections (cIAI), providing a new treatment option for pediatric patients with cIAI.

Peng Zhenke, President of Pfizer Global Biopharmaceuticals Commercial Group, China, stated: "The approval of the new indication for Zavicefta will actively help pediatricians overcome the clinical treatment challenges of complicated intra-abdominal infections (cIAI) caused by drug-resistant bacterial infections, saving the lives of young patients. Pfizer will continue to uphold the concept of 'bringing breakthrough innovations that change patients' lives,' accelerating the introduction of more innovative drugs to patients in China and contributing to the realization of 'Healthy China 2030'."

Previously, Zavicefta was approved in China in 2019 for the treatment of adult patients with cIAI, HAP/VAP, and for the treatment of infections caused by Gram-negative bacteria in adult patients with limited treatment options (LTO).

Complicated Intra-abdominal Infections in Children(cIAI)Treatment Dilemma Calls for Urgent Breakthrough

Complicated intra-abdominal infections (cIAI) refer to infections that extend from the primary hollow viscus to the abdominal cavity, leading to secondary or tertiary peritonitis, and may be associated with sepsis, septic shock, and multiple organ dysfunction syndrome.^[1]cIAI includes a variety of diseases, mainly including gastric and duodenal perforation, traumatic small intestine and colon rupture, non-traumatic small intestine and colon perforation, suppurative peritonitis or periappendiceal abscess caused by appendicitis perforation, gallbladder inflammation complicated with perforation or abscess, intra-abdominal abscess, intra-abdominal infection after abdominal surgery, etc.^[2]。

Alarmingly, the resistance of common G- pathogens in pediatric cIAI to carbapenem antibiotics is severe.^[3]A history of carbapenem antibiotic use is one of the high-risk factors for carbapenem-resistant Enterobacteriaceae (CRE) colonization or infection in children.^[4]`, while the 30-day mortality risk in CRE-infected pediatric patients is nearly six times higher than in those infected with carbapenem-sensitive Enterobacteriaceae (CSE).`^[5]。

There is an urgent clinical need for novel antibacterial drugs to break through the treatment困境 of pediatric cIAI and address the increasingly prominent challenge of drug resistance.

Focus on ChildrencIAITreatment 

Compared with adults, the antimicrobial treatment for pediatric cIAI must not only comprehensively consider various factors such as possible pathogens and the risk of drug-resistant infections, but also refer to the susceptibility of pathogens to antimicrobial agents, while taking into account the child's liver and kidney function as well as the severity of the disease.

As a new generation enzyme inhibitor combination, ceftazidime/avibactam can inhibit most β-lactamases, effectively covering common Gram-negative pathogens and carbapenem-resistant bacteria in cIAI. It has been approved in the United States and the European Union for the treatment of cIAI in children aged 3 months and above.

Real-world studies and case reports further confirm that ceftazidime/avibactam can be used as a salvage treatment option for pediatric patients with CRE intra-abdominal infections after liver transplantation.^[6]。

In the 2022 Infectious Diseases Society of America (IDSA) guidelines for the treatment of infections caused by drug-resistant Gram-negative bacteria, ceftazidime/avibactam is recommended as one of the first-line treatment options for carbapenem-resistant Enterobacterales (CRE) and difficult-to-treat resistance Pseudomonas aeruginosa (DTR-PA) infections in both adult and pediatric patients.^[7]。

^{[1] Branch of Surgery, Chinese Medical Association, et al. Chinese Journal of Surgery, 2021, 59(3): 161-178.
[2] Chen Dongxu, et al. China Emergency Medicine, 2019, 39(3): 298-300.
[3] He Leiyan, et al. Chinese Journal of Evidence-Based Pediatrics, 2021, 16(6): 414-420.
[4] Lin Biyu, et al. Chinese Journal of Contemporary Pediatrics, 2022, 24(1): 96-101.
[5] Chiotos K, et al. Open Forum Infect Dis. 2018 Sep 10;5(10):ofy222
[6] Infection and Drug Resistance 2022:15 3323–3332.
[7] Infectious Diseases Society of America Guidance.}