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

Bacteremia Clinical Trial

Official title:

AN OPEN-LABEL, RANDOMIZED, MULTI-CENTER, ACTIVE-CONTROLLED STUDY TO ESTIMATE THE EFFICACY AND SAFETY OF CEFTAZIDIME-AVIBACTAM (CAZ-AVI) VERSUS BEST AVAILABLE TREATMENT (BAT) IN THE TREATMENT OF INFECTIONS DUE TO CARBAPENEM-RESISTANT GRAM-NEGATIVE PATHOGENS IN CHINESE ADULTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04882085
• Other study ID #: C3591033
• Status: Completed
• Phase: Phase 4
• Start date: August 26, 2021
• Est. completion date: August 31, 2023

Study information

• Verified date: December 2023
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pyelonephritis
• Bacteremia
• Communicable Diseases
• Healthcare-Associated Pneumonia
• Hospital Acquired Pneumonia
• Infections
• Intra-abdominal Infection
• Intraabdominal Infections
• Pneumonia
• Pneumonia, Ventilator-Associated
• Pyelonephritis
• Urinary Tract Infection
• Urinary Tract Infections
• Ventilator-associated Pneumonia

Intervention

Drug:
• Zavicefta, Ceftazidime-Avibactam
CAZ-AVI 2.5 g (2 g ceftazidime + 0.5 g avibactam) administered IV as a 2 hour infusion every 8 hours. Dose adjustments are available for participants with CrCL =50 mL/min.
• Best Available Treatment
main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Baotou Central Hospital	Baotou	Inner Mongolia Autonomous Region
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical	Bengbu	Anhui
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Chengdu Xinhua Hospital	Chengdu	Sichuan
China	Chizhou People's Hospital	Chizhou	Anhui
China	Fuyang People's Hospital	Fuyang	Anhui
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Affiliated Hospital of Guilin Medical College	Guilin	Guangxi
China	Zhejiang Hospital	Hangzhou	Zhejiang
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	Jiangyin People's Hospital	Jiangyin
China	Jiangyin People's Hospital	Jiangyin	Jiangsu
China	The First people's Hospital of Kunming	Kunming	Yunnan
China	The First People's Hospital of Kunming (South Hospital)	Kunming	Yunnan
China	The First People's Hospital of Kunming Ganmei Hospital (North Hospital)	Kunming	Yunnan
China	Lishui People's Hospital	Lishui	Zhejiang
China	Luoyang Central Hospital	Luoyang	Henan
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	NanYang central hospital	Nanyang	Henan
China	Qingyuan People's Hospital	Qingyuan	Guangdong
China	Huashan Hospital, Fudan University	Shanghai	Shanghai
China	Shanghai Fifth People's Hospital, Fudan University	Shanghai
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The Second People's Hospital of Shenzhen	Shenzhen	Guangdong
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Tianjin Chest Hospital	Tianjin	Tianjin
China	The 2nd Affiliated Hospital of WMU	Wenzhou	Zhejiang
China	Wenzhou Central Hospital	Wenzhou	Zhejiang
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Subei People's Hospital of Jiangsu province	Yangzhou	Jiangsu
China	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	Henan provincial people's hospital	Zhengzhou	Henan
China	Henan provincial people's hospital	Zhengzhou	Henan
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of participants in Microbiologically Modified Intent to Treat (mMITT) analysis set having clinical cure		Test of Cure (TOC, Day 21 - 25)
Secondary	The percentage of participants in mMITT analysis set having clinical cure		End of Treatment (EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Secondary	The percentage of participants in Microbiologically Evaluable (ME) analysis set having clinical cure		End of Treatment (EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Secondary	The percentage of participants in ME analysis set having clinical cure		Test of Cure (TOC, Day 21-Day 25)
Secondary	The percentage of participants in mMITT analysis set having favorable microbiological response		Test of Cure(TOC, Day 21-Day 25)
Secondary	The percentage of participants in mMITT analysis set having favorable microbiological response		End of Treatment (EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Secondary	The percentage of participants in ME analysis set having favorable microbiological response		End of Treatment (EOT, participants were followed after the last IV dose but no later than 24 hours after the last IV dose)
Secondary	The percentage of participants in ME analysis set having favorable microbiological response		Test of Cure(TOC, Day 21-Day 25)
Secondary	The percentage of participants who have died due to any cause		Day 28
Secondary	The number of treatment-emergent adverse events		up to 32 days after the last dose of study intervention
Secondary	The percentage of participants experiencing the AEs		up to 32 days after the last dose of study intervention

External Links

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