Complicated Intra-abdominal InfectionNCT05733104
A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea
An observational study of Complicated Intra-abdominal Infection and Complicated Urinary Tract Infection, run by Pfizer at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection, Hospital-acquired Pneumonia
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Feb 2024to 28 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
- 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
- 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.
- Patients are treated with Zavicefta for the first time
- Patients have signed the data privacy statement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV
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.
Read the 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".
- Serious adverse event/adverse drug reaction
- Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
- Known adverse drug reaction
- Non-serious adverse drug reaction
- 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.
- Conditions
- Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection, Hospital-acquired Pneumonia
- Keywords
- Ceftazidime, Avibactam, safety, efficacy
- Medical subject headings
- Healthcare-Associated Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient reporting an adverse event
Safety will be assessed based on adverse events reported for all patients who received at least one dose of Zavicefta and completed safety follow-up.
Measured: From first dose to end of the observation period (at least 28 calendar days following the last dose)
Secondary outcomes (1)
Clinical response: Number of patient recorded as cure
Clinical response will be evaluated as follows based on subjective assessment by the investigator after the patient has been subjected to the conditions corresponding to each clinical response item or after interviewing the patient at the end of treatment:
Cure: Complete resolution or significant improvement of signs and symptoms of the index infection, such that no further antibacterial therapy was necessary
Failure: Death related to the index infection or received treatment with additional antibiotics for ongoing symptoms of index infection
Indeterminate: study data were not available for evaluation of effectiveness for any reason
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start19 Feb 2024
- Primary completion28 Sep 2029 (estimated)
- Study completion28 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complicated Intra-abdominal InfectionStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05733104
- Sponsor's protocol ID
- C3591027
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Post Marketing Surveillance Study to Observe Safety and Effectiveness of Zavicefta IV
- ClinicalTrials.gov ID
- NCT05733104
- Acronym / sponsor ID
- C3591027
- Conditions
- Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection, Hospital-acquired Pneumonia
- Keywords
- Ceftazidime, Avibactam, safety, efficacy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2024 (actual)
- Primary completion
- 28 Sep 2029 (estimated)
- Study completion
- 28 Sep 2029 (estimated)
- First posted
- 17 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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".
- Serious adverse event/adverse drug reaction
- Unexpected adverse event/adverse drug reaction that have not been reflected in the approved drug label.
- Known adverse drug reaction
- Non-serious adverse drug reaction
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patient reporting an adverse event
Time frame: From first dose to end of the observation period (at least 28 calendar days following the last dose)
Safety will be assessed based on adverse events reported for all patients who received at least one dose of Zavicefta and completed safety follow-up.
1 secondary outcome
Clinical response: Number of patient recorded as cure
Time frame: up to one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complicated Intra-abdominal Infection and Complicated Urinary Tract Infection, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient reporting an adverse event (time frame: From first dose to end of the observation period (at least 28 calendar days following the last dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.