Clinical trial NCT05733104: A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
Official title: Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complicated Intra-abdominal Infection
Complicated Urinary Tract Infection
Hospital-acquired Pneumonia
Keywords: Ceftazidime
Avibactam
safety
efficacy
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2023-02-17
Enrollment: 600
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At least 600 subjects who are eligible for Zavicefta IV accoding to its product label will be enrolled by continuous registration method and will be researched under routine clinical setting of Korea.

Brief summary: The purpose of this study is to learn about the safety and effectiveness of Zavicefta once released into the markets in Korea. This study is to learn about Zavicefta in patients with difficult types of infections in the abdomen, urinary tract and pneumonia which could have come from hospitalizations.

This study was required by the Ministry of Food and Drug Safety (MFDS) of Korea's regulations.

Detailed description: The objective of this study is to determine any problems or questions associated with Zavicefta after marketing, with regard to the following clauses under conditions of general clinical practice, in compliance with the regulation "Re-examination Guideline of New Drugs".

1. Serious adverse event/adverse drug reaction
2. Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
3. Known adverse drug reaction
4. Non-serious adverse drug reaction
5. Other safety and effectiveness information As required for any new medication approved by Ministry of Food and Drug Safety (MFDS), information on safety and effectiveness of new medication should be researched on certain number of subjects taking the drug in the setting of routine practice during the initial 6 years after the approval of new drug. This reserach shall begin after approval of marketing in Korea by MFDS.

Eligibility criteria: 1. Adults and paediatric patients aged 3 months and older, who have been administered at least one dose of Zavicefta for the treatment of one of the indications as follows:

   * Complicated intra-abdominal infection (cIAI)
   * Complicated urinary tract infection (cUTI), including pyelonephritis
   * Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP)
   * Other aerobic Gram-negative organism infection with limited treatment options
2. Adults 19 years of age or older, who have been administered at least one dose of Zavicefta for the treatment of the indication as follows:

   •Bacteremia associated with or suspected to be associated with cIAI, cUTI or HAP including VAP.
3. Patients are treated with Zavicefta for the first time
4. Patients have signed the data privacy statement.

Primary outcomes:
measure: Number of patient reporting an adverse event
timeFrame: From first dose to end of the observation period (at least 28 calendar days following the last dose)
Secondary outcomes:
measure: Clinical response: Number of patient recorded as cure
timeFrame: up to one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Pfizer
state: Gangnam-gu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: