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Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults

NCT04882085

CompletedPhase 4

Sponsor: Pfizer

Conditions: Urinary Tract Infection, Acute Pyelonephritis, Hospital Acquired Pneumonia, Ventilator-associated Pneumonia, Bacteremia

Interventions: Zavicefta, Ceftazidime-Avibactam, Best Available Treatment

Countries: China

This is an open-label, randomized, multi-center, interventional, active-controlled Phase 4 study to evaluate the efficacy and safety of CAZ-AVI versus BAT in the treatment of infected participants with selected infection types (Hospital Acquired Pneumonia \[HAP\] (including Ventilator-Associated Pneumonia \[VAP\]); Complicated Urinary-Tract Infection \[cUTI\]; Complicated Intra-Abdominal Infection \[cIAI\]; Bloodstream Infection \[BSI\]) due to carbapenem-resistant Gram-negative pathogens in China.This study will be an estimation study. The statistical inference will be based on point estimate and confidence interval.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male or female \>18 years of age
* Participant must have a diagnosis of an infection (HAP/VAP, cUTI, cIAI, BSI) due to confirmed carbapenem-resistant aerobic Gram-negative pathogens, requiring administration of IV antibacterial therapy
* Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy.
* Capable of giving signed informed consent

Exclusion Criteria:

* Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Participant is expected to require more than 21 days of treatment
* Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
* Previous administration with an investigational drug within 30 days or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer).
* Participant is pregnant or breastfeeding.
* Acute Physiology and Chronic Health Evaluation (APACHE) II score \>30 or \<10 using the most recent available data.

Locations (37)

Bengbu, Anhui, China
Bengbu, Anhui, China
Chizhou, Anhui, China
Fuyang, Anhui, China
Beijing, Beijing Municipality, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Qingyuan, Guangdong, China
Shenzhen, Guangdong, China
Shenzhen, Guangdong, China
Zhanjiang, Guangdong, China
Guilin, Guangxi, China
Zunyi, Guizhou, China
Baoding, Hebei, China
Luoyang, Henan, China
Nanyang, Henan, China
Zhengzhou, Henan, China
Zhengzhou, Henan, China
Baotou, Inner Mongolia, China
Jiangyin, Jiangsu, China
Xuzhou, Jiangsu, China
Yangzhou, Jiangsu, China
Nanchang, Jiangxi, China
Shanghai, Shanghai Municipality, China
Chengdu, Sichuan, China
Tianjin, Tianjin Municipality, China
Kunming, Yunnan, China
Kunming, Yunnan, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
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