Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections
NCT04628572
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Gram Negative Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. more than or equal to 18 years of age
2. Admitted to hospital with documented gram negative infection
3. Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
1. The patient is enrolled in any clinical trial of an investigational product
2. Age <18 years
3. Received Ceftazidime avibactam for less than 48 hours.
4. Patient with documented Acinetobacter infection.
5. Patient was a part of named access program or any other interventional study
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Gram Negative InfectionsRetrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections
NCT04628572
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections | ||||||
| Official Title | Retrospective Analysis to Characterize the Real World Use Patterns, Efficacy and Safety of Ceftazidime-avibactam in the Management of Gram Negative Infections | ||||||
| Brief 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. 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Observational Model: Other Time Perspective: Retrospective | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| Study Population | Hospitalized patients with documented gram negative infection and treated with Ceftazidime-avibactam for atleast 48 hours. | ||||||
| Condition | Gram Negative Infections | ||||||
| Intervention | Drug: Ceftazidime-avibactam
Non-Interventional Study | ||||||
| Study Groups/Cohorts | Cohort 1
Eligible adults who have been treated with ? 48 hours of ceftazidime-avibactam in routine practice Intervention: Drug: Ceftazidime-avibactam | ||||||
| Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status | Not yet recruiting | ||||||
| Estimated Enrollment | 500 | ||||||
| Original Estimated Enrollment | Same as current | ||||||
| Estimated Study Completion Date | January 31, 2021 | ||||||
| Estimated Primary Completion Date | January 31, 2021 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT04628572 | ||||||
| Other Study ID Numbers | X9001260 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor | Pfizer | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Pfizer | ||||||
| Verification Date | November 2020 | ||||||