Infectious DiseasesNCT06864585
A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan
An observational study of Infectious Diseases, run by Pfizer at 1 site in Japan.
Trial summary
The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan. Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Infectious Diseases
- What is being tested?
- Avibactam sodium/Ceftazidime hydrate
- Type of treatment
- Injection or infusion
- How many people
- 59 participants
- Where
- 1 siteJapan
- Study dates
- 20 Apr 2026to 30 Mar 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta for the first time
Who may be able to join
- Patients who received Zavicefta for the first time after the launch of Zavicefta
- Patients who received Zavicefta for an infectious diseases indicated for Zavicefta
- Patients with diagnosis of sepsis and/or renal impairment (creatinine clearance ≤ 50mL/min) at the start of the treatment with Zavicefta
- Individuals who understand the nature of this study and give consent for the provision of the information collected in this study to third parties and the use of the information for other than intended use
Who cannot join
- There are no exclusion criteria for this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zavicefta Combination for Intravenous Infusion Special Investigation - Surveillance on Patients With Sepsis or Renal Impairment (Creatinine Clearance ≤ 50 mL/Min) -
The purpose of this study is to learn about the safety and how effective is Zavicefta under actual clinical practice in Japan.
Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate.
This study is seeking for patients with:
- sepsis (A very serious infection in your blood caused by germ (a bacteria)) or
- renal impairment (loss of kidney function) who are administrated with Zavicefta for the first time.
Subjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.
- Conditions
- Infectious Diseases
- Being tested
- Avibactam sodium/Ceftazidime hydrate
- Keywords
- Sepsis; Renal impairment; Zavicefta; Avibactam; Ceftazidime
- Medical subject headings
- Communicable Diseases, Sepsis, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avibactam sodium/Ceftazidime hydrateDrug
Also called Zavicefta
The recommended adult dosage is 2.5 g (0.5 g of avibactam and 2 g of ceftazidime) administered by intravenous infusion over a period of 2 hours 3 times daily. For peritonitis, intra-abdominal abscess, cholecystitis, and liver abscess, Zavicefta should be co-administered with a metronidazole injection.
| Study group | Role | What they receive |
|---|---|---|
| Avibactam sodium/Ceftazidime hydrate | Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta (Avibactam sodium/Ceftazidime hydrate) for the first time Receives: Drug: Avibactam sodium/Ceftazidime hydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with adverse drug reactions (ADRs)
Measured: From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)
Secondary outcomes (2)
Number of Participants with Clinical Effectiveness
Measured: From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)
Number of Participants with Clinical Effectiveness at the time of Test of Cure
Measured: 28 days after the start of the administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start20 Apr 2026
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
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
- NCT06864585
- Sponsor's protocol ID
- C3591038
- Status last verified
- Jun 2026
- First submitted
- 3 Mar 2025
- Last updated
- 17 Aug 2026
- Results posted
- 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zavicefta Combination for Intravenous Infusion Special Investigation - Surveillance on Patients With Sepsis or Renal Impairment (Creatinine Clearance ≤ 50 mL/Min) -
- ClinicalTrials.gov ID
- NCT06864585
- Acronym / sponsor ID
- C3591038
- Conditions
- Infectious Diseases
- Keywords
- Sepsis; Renal impairment; Zavicefta; Avibactam; Ceftazidime
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 7 Mar 2025 (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 how effective is Zavicefta under actual clinical practice in Japan.
Zavicefta is a combination of Avibactam sodium and Ceftazidime hydrate.
This study is seeking for patients with:
- sepsis (A very serious infection in your blood caused by germ (a bacteria)) or
- renal impairment (loss of kidney function) who are administrated with Zavicefta for the first time.
Subjects will take part in this study from the start date of receiving Zavicefta (Day 1) to Day 28.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Avibactam sodium/Ceftazidime hydrate | – | Drug: Avibactam sodium/Ceftazidime hydratePatients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta (Avibactam sodium/Ceftazidime hydrate) for the first time |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta for the first time
Key inclusion criteria (4 listed)
- Patients who received Zavicefta for the first time after the launch of Zavicefta
- Patients who received Zavicefta for an infectious diseases indicated for Zavicefta
- Patients with diagnosis of sepsis and/or renal impairment (creatinine clearance ≤ 50mL/min) at the start of the treatment with Zavicefta
- Individuals who understand the nature of this study and give consent for the provision of the information collected in this study to third parties and the use of the information for other than intended use
Key exclusion criteria (1 listed)
- There are no exclusion criteria for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Avibactam sodium/Ceftazidime hydrateAlso: ZaviceftaThe recommended adult dosage is 2.5 g (0.5 g of avibactam and 2 g of ceftazidime) administered by intravenous infusion over a period of 2 hours 3 times daily. For peritonitis, intra-abdominal abscess, cholecystitis, and liver abscess, Zavicefta should be co-administered with a metronidazole injection. | Drug | Avibactam sodium/Ceftazidime hydrate |
Primary outcome
Number of Participants with adverse drug reactions (ADRs)
Time frame: From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)
2 secondary outcomes
Number of Participants with Clinical Effectiveness
Time frame: From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)
Number of Participants with Clinical Effectiveness at the time of Test of Cure
Time frame: 28 days after the start of the administration
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 17 Aug 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. This study is not recruiting at the moment.
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 Infectious Diseases, run by Pfizer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 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 Japan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with adverse drug reactions (ADRs) (time frame: From the start date of the administration to 28 days after the administration (or 14 days after the date of discontinuation if the administration is discontinued)). 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 17 Aug 2026.