Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections

NCT04628572

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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
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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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
 (submitted: November 12, 2020)
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:

  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:

  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
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD:No
Plan Description: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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2020