Complicated Intra-abdominal Infection, Complicated Urinary Tract Infection, Hospital-acquired Pneumonia
Conditions
Keywords
Ceftazidime, Avibactam, safety, efficacy
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.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patient reporting an adverse event | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical response: Number of patient recorded as cure | up to one year | 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 |
Countries
South Korea
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed