N/A
Completed N=572
Real-World Observational Study Of Zavicefta to Characterize Use Patterns
Source: ClinicalTrials.gov NCT03923426 ↗Enrolled (actual)
572
Serious AEs
0.9%
Results posted
Dec 2023
Primary outcomePrimary: Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population — 158; 358 Participants
Summary
This is a non-interventional medical chart review study aiming to examine the treatment patterns, effectiveness, and safety of ceftazidime-avibactam in approximately 12 countries (including but not limited to Austria, France, Germany, Greece, Italy, Spain, United Kingdom, Russia, Argentina, Colombia, Brazil, and Mexico), with possible expansion to other countries as ceftazidime-avibactam is launched. Eligible patients are adults who have been treated with ceftazidime-avibactam in routine practice at participating sites since 01 January, 2018 onwards or since the date of launch in the country if it is posterior to 01 January, 2018. As this is an observational study, patients will be treated based on the standard of care at the discretion of their physician. No drugs will be supplied for this study and patients will receive treatment through standard local practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS 72+ Population |
158; 358 | — |
| PRIMARY Number of Participants Who Received at Least One Dose of Ceftazidime-Avibactam Classified According to Type of Usage as Monotherapy or Combination Therapy: FAS72- Population |
3; 7 | — |
| PRIMARY Total and Daily Dose of Ceftazidime-Avibactam: FAS72+ Population |
62.2; 5.2 | — |
| PRIMARY Total and Daily Dose of Ceftazidime-Avibactam: FAS72- Population |
6.3; 4.8 | — |
| PRIMARY Number of Participants Classified According to Frequency of Dosing: FAS72+ Population |
4; 4; 1; 1; 1; 13 | — |
| PRIMARY Number of Participants Classified According to Frequency of Dosing: FAS72- Population |
1; 1; 2; 1; 1; 1 | — |
| PRIMARY Total Duration of Administration of Ceftazidime-Avibactam: FAS72+ Population |
9.0 | — |
| PRIMARY Total Duration of Administration of Ceftazidime-Avibactam: FAS72- Population |
1.0 | — |
| PRIMARY Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72+ Population |
3; 10; 9; 2; 11; 5 | — |
| PRIMARY Number of Participants Classified According to Reason for Discontinuation of Ceftazidime-Avibactam: FAS72- Population |
0; 1; 6; 1; 2; 0 | — |
| PRIMARY Number of Participants Classified According to Antibiotics Used Concurrently: FAS 72+ Population |
58; 19; 6; 1; 1; 1 | — |
| PRIMARY Number of Participants Classified According to Reason for Initiating Antibiotics: FAS 72+ Population |
7; 2; 30; 18; 1; 1 | — |
| PRIMARY Number of Participants Classified According to Reason for Discontinuing Antibiotics: FAS 72+ Population |
4; 5; 6; 1; 13; 15 | — |
| PRIMARY Number of Participants Whose Samples Were Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: Microbiology Outcomes Dataset (MOD) Population |
20 | — |
| PRIMARY Number of Participants Classified According to Type of Specimen Taken for Clinical Microbiological Evaluation After End of Ceftazidime-Avibactam Therapy: MOD Population |
10; 4; 4; 5; 1; 3 | — |
| PRIMARY Number of Participants Classified According to the Pathogens Identified From the Microbiological Culture After Treatment Initiation: MOD Population |
4; 15; 1; 6; 2; 1 | — |
| PRIMARY Number of Gram-Negative Pathogens According to the Susceptibility to Antibiotics After Treatment Initiation: FAS72+ Population |
39; 2; 39; 13; 17; 31 | — |
| PRIMARY Number of Gram-Negative Pathogens According to the Multi-Drug Resistance After Treatment Initiation: FAS72+ Population |
21; 2; 25; 13; 12; 20 | — |
| PRIMARY Number of Participants Classified According to Type of Clinical Evaluation Outcome at Initial Hospitalization: Clinical Outcomes Dataset (COD) Population |
399; 60; 57 | — |
| PRIMARY Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Discharge: Clinical Outcomes Dataset (COD) Population |
266; 27; 24 | — |
| PRIMARY Number of Participants Classified According to Type of Clinical Evaluation Outcome 60 Days Post-Treatment: Clinical Outcomes Dataset (COD) Population |
311; 32; 31 | — |
| PRIMARY Number of Participants With Microbiological Treatment Outcome as Success: MOD Population |
— | — |
| PRIMARY Number of Participants Classified According to Antibiotics Used for Current Infection Before Ceftazidime-Avibactam: FAS72+ Population |
397; 119 | — |
| PRIMARY Number of Participants Classified According to Reason for Discontinuation for Prior Antibiotic Therapy: FAS72+ Population |
11; 134; 236; 32; 35; 4 | — |
| PRIMARY Percentage of Participants Who Died During Index Hospitalization |
23.1 | — |
| PRIMARY Percentage of Participants Who Died Within the 30 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population |
24.6 | — |
| PRIMARY Percentage of Participants Who Died Within 60 Days After Hospital Discharge (Including In-Hospital Mortality): FAS72+ Population |
27.9 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
6; 5 | — |
| PRIMARY Duration of Hospital Stay: FAS72+ Population |
36.0 | — |
| PRIMARY Total Duration of ICU Stay: FAS72+ Population |
24.0 | — |
| PRIMARY Number of Participants Readmitted to the Hospital During the 30 Days After Initial Discharge: FAS72+ Population |
111 | — |
| PRIMARY Number of Participants Readmitted to the Hospital During the 60 Days After Initial Discharge: FAS72+ Population |
53 | — |
| PRIMARY Number of Participants Classified According to Reason for Readmission to the Hospital: FAS72+ Population |
98; 25; 17; 6 | — |
| PRIMARY Number of Participants Classified According to the Healthcare Resource Utilized During the Hospitalization: FAS72+ Population |
161; 80; 273; 83; 169; 149 | — |
| PRIMARY Number of Participants Classified According to All Wards Attended During Hospitalization: FAS72+ Population |
101; 195; 58; 27; 116; 18 | — |
Eligibility Criteria
Inclusion Criteria
- Hospitalized patient ≥18 years old or considered an adult in accordance with the age of majority in the participant's country of residence at the time of treatment with ceftazidime-avibactam.
- Patient received ≥1 dose of ceftazidime-avibactam in routine practice at participating site since 01 January, 2018 onwards or since the date of launch in the country if it is after 01 January, 2018.
- Patient underwent microbiologic sampling ≤5 days before the initiation of ceftazidime-avibactam (irrespective of results and actual bacteriological identification).
- Patient has all required essential data elements which include:
- Start and stop dates of ceftazidime-avibactam,
- Start and stop dates of prior antibiotic therapy used for the index infection,
- Type of combined antibiotic therapy (if applicable) and start and stop dates of any antibiotic combined with ceftazidime-avibactam.
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study where required by local regulations.
Exclusion Criteria
Patients must not meet any of the following exclusion criteria to be eligible:
- The patient is enrolled in any clinical trial of an investigational product. Patients who are enrolled in non-interventional studies (NISs) (e.g. registries) are eligible for inclusion.
- The patient has received ceftazidime-avibactam in a compassionate care program setting.
- The patient was exposed to ceftazidime-avibactam before use for the index infection.
Data sourced from ClinicalTrials.gov (NCT03923426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.