Gram Negative InfectionsNCT04628572
Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections
An observational study of Gram Negative Infections, run by Pfizer at 8 sites in India.
Trial summary
The main objective of this non-interventional (retrospective) study is to describe the general treatment patterns, effectiveness, and safety of ceftazidime-avibactam in real-world settings in India. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram Negative Infections
- What is being tested?
- Ceftazidime-avibactam
- How many people
- 189 participants
- Where
- 8 sitesIndia
- Study dates
- 29 Jan 2021to 11 Mar 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hospitalized patients with documented gram negative infection and treated with Ceftazidime-avibactam for atleast 48 hours.
Who may be able to join
- more than or equal to 18 years of age
- Admitted to hospital with documented gram negative infection
- Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management
Who cannot join
- The patient is enrolled in any clinical trial of an investigational product
- Age <18 years
- Received Ceftazidime avibactam for less than 48 hours.
- Patient with documented Acinetobacter infection.
- Patient was a part of named access program or any other interventional study
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
India8 sites
Fortis Hospital
Bhandup West, 400078
Apollo Hospital
Chennai, 600006
Gleneagles Global Hospitals
Chennai, 600100
Deenanath Mangeshkar Hospital and Research Centre
Erandwane,, PUNE, 411004
Apollo Hospital
Hyderabad, HYDERABAD
Metro Hospital
Noida, 201301
Grant Medical Foundation Ruby Hall Clinic
Pune, 411001
Amri Hospital
WEST Bengal, 700098
About this study
Official title: Retrospective Analysis to Characterize the Real World Use Patterns, Efficacy and Safety of Ceftazidime-avibactam in the Management of Gram Negative Infections.
The main objective of this non-interventional (retrospective) study is to describe the general treatment patterns, effectiveness, and safety of ceftazidime-avibactam in real-world settings in India. Eligible patients would be adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice from 01 June 2019 to 01 April 2020. Data of 500 patients will be collected through the abstraction of hospital medical records (electronic) if available or through the individual patient medical record in case electronic records are not available.
- Conditions
- Gram Negative Infections
- Being tested
- Ceftazidime-avibactam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ceftazidime-avibactamDrug
Non-Interventional Study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Eligible adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice Receives: Drug: Ceftazidime-avibactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Clinical Symptom Improvement at Day 3
The clinical symptom improvement was assessed as per the clinical judgement of the physician and reported as symptom improved and symptom worsened.
Measured: Day 3 after ceftazidime-avibactam initiation
Number of Participants With Treatment Success at Day 7
The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success).
Measured: Day 7 after ceftazidime-avibactam initiation
Number of Participants With Treatment Success at Day 14 or End of Treatment
The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success).
Measured: Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants With Microbiological Success at Day 7
Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication).
Measured: Day 7 after ceftazidime-avibactam initiation
Number of Participants With Microbiological Success at Day 14 or End of Treatment
Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication).
Measured: Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. All AEs that did not meet the criteria for "serious" were considered as non-serious. Adverse events with explicit attribution to any Pfizer drug that appeared in the reviewed information (defined per the participant population and study period specified in the protocol) were reported. Explicit attribution was not inferred by temporal relationship between drug administration and an AE, but was based on a causality assessed by a healthcare provider linking drug administration and AE.
Measured: Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)
Secondary outcomes (14)
Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used
Source of infection included hospital-acquired infection, healthcare-associated infection, and community-acquired infection.
Measured: Baseline (before initiation of initial antibiotic therapy)
Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used
The indications for use of ceftazidime-avibactam at baseline including urinary tract infection, intra-abdominal infection and nosocomial pneumonia and any other indication were reported.
Measured: Baseline (before the initiation of initial antibiotic therapy)
Dose of Ceftazidime - Avibactam
In this outcome measure dose (median of daily dose) of ceftazidime-avibactam was reported till Day 14 or End of treatment whichever was earlier.
Measured: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants According to Frequency of Administration
Number of participants according to frequency of administration (twice daily [BID], once daily [OD] and thrice daily [TID]) of ceftazidime-avibactam is reported in this outcome measure.
Measured: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Duration of Administration of Ceftazidime - Avibactam
Measured: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Total Duration of Therapy of Ceftazidime-Avibactam
Measured: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants Who Received Concomitant Antibiotics With Ceftazidime-Avibactam
Measured: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants With History of Antibiotic Exposure
Measured: 90 days prior to current hospital admission
Number of Participants According to Identified Gram Negative Organisms
In this outcome measure, the gram-negative organisms identified at baseline was reported. One participant could have more than one gram-negative bacteria identified.
Measured: Baseline (before the initiation of initial antibiotic therapy)
Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam
Measured: Baseline (before the initiation of initial antibiotic therapy)
Duration of Hospital Stay
Duration of hospital stay was calculated based on 1) total number of consecutive days the participant was treated in the hospital from admission to discharge during their initial hospitalization; 2) the total number of days of hospitalization between diagnosis of infection and discharge; 3) the total number of days the participant was treated in the hospital after ceftazidime-avibactam initiation up to hospital discharge, including the first day of treatment.
Measured: Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days)
Duration of Stay in Intensive Care Unit (ICU)
Intensive care unit length of stay was calculated based on 1) the total number of consecutive or non-consecutive days the participant was treated in the ICU during their initial hospitalization; and 2) the total number of days the participant was treated in the ICU after ceftazidime-avibactam initiation, including the first day of treatment.
Measured: Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days)
Number of Participants According to Healthcare Resource Utilization
In this outcome measure number of participants were reported as per their healthcare resource utilization data, abstracted from the participant medical records. Healthcare resources included: mechanical ventilation, computed tomography (CT)/magnetic resonance imaging (MRI), tracheostomy, hemodialysis, surgical intervention, percutaneous procedures and other procedures.
Measured: Up to 30 days post treatment completion with ceftazidime-avibactam death or discharge; whichever was first (Up to maximum of 49 days)
Number of Participants With Recurrence of Infection
Number of participants with recurrence of infection during hospital stay, including re-infection and relapse up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever occurred first was summarized in this outcome measure.
Measured: Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start29 Jan 2021
- Primary completion11 Mar 2022
- Study completion11 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gram Negative InfectionsStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 189 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
- NCT04628572
- Sponsor's protocol ID
- X9001260
- Status last verified
- Feb 2024
- First submitted
- 7 Oct 2020
- Last updated
- 14 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis to Characterize the Real World Use Patterns, Efficacy and Safety of Ceftazidime-avibactam in the Management of Gram Negative Infections.
- ClinicalTrials.gov ID
- NCT04628572
- Acronym / sponsor ID
- X9001260
- Conditions
- Gram Negative Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 11 Mar 2022 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Posted 14 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this non-interventional (retrospective) study is to describe the general treatment patterns, effectiveness, and safety of ceftazidime-avibactam in real-world settings in India. Eligible patients would be adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice from 01 June 2019 to 01 April 2020. Data of 500 patients will be collected through the abstraction of hospital medical records (electronic) if available or through the individual patient medical record in case electronic records are not available.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Drug: Ceftazidime-avibactamEligible adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with documented gram negative infection and treated with Ceftazidime-avibactam for atleast 48 hours.
Key inclusion criteria (3 listed)
- more than or equal to 18 years of age
- Admitted to hospital with documented gram negative infection
- Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management
Key exclusion criteria (5 listed)
- The patient is enrolled in any clinical trial of an investigational product
- Age <18 years
- Received Ceftazidime avibactam for less than 48 hours.
- Patient with documented Acinetobacter infection.
- Patient was a part of named access program or any other interventional 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 |
|---|---|---|
| Ceftazidime-avibactamNon-Interventional Study | Drug | Cohort 1 |
Primary outcome
Number of Participants With Clinical Symptom Improvement at Day 3
Time frame: Day 3 after ceftazidime-avibactam initiation
The clinical symptom improvement was assessed as per the clinical judgement of the physician and reported as symptom improved and symptom worsened.
Number of Participants With Treatment Success at Day 7
Time frame: Day 7 after ceftazidime-avibactam initiation
The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success).
Number of Participants With Treatment Success at Day 14 or End of Treatment
Time frame: Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success).
Number of Participants With Microbiological Success at Day 7
Time frame: Day 7 after ceftazidime-avibactam initiation
Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication).
Number of Participants With Microbiological Success at Day 14 or End of Treatment
Time frame: Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication).
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam
Time frame: Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. All AEs that did not meet the criteria for "serious" were considered as non-serious. Adverse events with explicit attribution to any Pfizer drug that appeared in the reviewed information (defined per the participant population and study period specified in the protocol) were reported. Explicit attribution was not inferred by temporal relationship between drug administration and an AE, but was based on a causality assessed by a healthcare provider linking drug administration and AE.
14 secondary outcomes
Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used
Time frame: Baseline (before initiation of initial antibiotic therapy)
Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used
Time frame: Baseline (before the initiation of initial antibiotic therapy)
Dose of Ceftazidime - Avibactam
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants According to Frequency of Administration
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Duration of Administration of Ceftazidime - Avibactam
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Total Duration of Therapy of Ceftazidime-Avibactam
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants Who Received Concomitant Antibiotics With Ceftazidime-Avibactam
Time frame: Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants With History of Antibiotic Exposure
Time frame: 90 days prior to current hospital admission
Number of Participants According to Identified Gram Negative Organisms
Time frame: Baseline (before the initiation of initial antibiotic therapy)
Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam
Time frame: Baseline (before the initiation of initial antibiotic therapy)
Duration of Hospital Stay
Time frame: Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days)
Duration of Stay in Intensive Care Unit (ICU)
Time frame: Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days)
Number of Participants According to Healthcare Resource Utilization
Time frame: Up to 30 days post treatment completion with ceftazidime-avibactam death or discharge; whichever was first (Up to maximum of 49 days)
Number of Participants With Recurrence of Infection
Time frame: Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gram Negative Infections, run by Pfizer at 8 sites in India.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in India. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Clinical Symptom Improvement at Day 3 (time frame: Day 3 after ceftazidime-avibactam initiation). The study lists 6 primary outcomes in all. 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 14 Aug 2024.