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A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan

ConditionInfectious Diseases
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0+
SponsorPfizer

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Patients with sepsis or renal impairment (creatinine clearance ≤ 50 mL/min) who are administrated with Zavicefta for the first time

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Avibactam sodium/Ceftazidime hydrate

    Drug

    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.

Treatment groups

59 Participants
are divided into 1 treatment group
Group A: Avibactam sodium/Ceftazidime hydrate1 intervention

Trial outcomes

Primary outcomes

1

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)

Secondary outcomes

1

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)
2

Number of Participants with Clinical Effectiveness at the time of Test of Cure

Time frame
28 days after the start of the administration

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pfizer

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: