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

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ClinicalTrials.gov Identifier: NCT04628572
Recruitment Status : Active, not recruiting
First Posted : November 13, 2020
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date October 7, 2020
First Posted Date November 13, 2020
Last Update Posted Date May 6, 2021
Actual Study Start Date February 1, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2020)
  • Percent treatment success of patients treated with ceftazidime-avibactam [ Time Frame: At Day 7 from ceftazidime avibactam initiation ]
  • Percent treatment success of patients treated with ceftazidime-avibactam [ Time Frame: At day 14/ End of treatment from Ceftazidime-avibactam initiation, whichever is earlier ]
  • Percent microbiological success among patients treated with ceftazidime-avibactam [ Time Frame: At Day 7 from ceftazidime-avibactam initiation ]
  • Percent microbiological success among patients treated with ceftazidime-avibactam [ Time Frame: At day 14/ end of the treatment from Ceftazidime- avibactam initiation, whichever is earlier ]
  • Number of patients with serious and non-serious AEs with explicit attribution to Ceftazidime avibactam [ Time Frame: Upto 30 days post treatment completion with Ceftazidime- Avibactam, death or discharge; whatever is first ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 12, 2020)
  • Percentage of patients with different sources of infection for which ceftazidime-avibactam was used. [ Time Frame: At baseline ]
  • Percentage of patients given ceftazidime avibactam for different indications [ Time Frame: At baseline ]
  • Describe the dose of ceftazidime avibactam in mg [ Time Frame: Till 14 days/ End of the treatment with Ceftazidime-avibactam , whichever is earlier ]
  • Describe the frequency of dosing for ceftazidime- avibactam in hours [ Time Frame: Till 14 days/ End of the treatment with ceftazidime- avibactam, whichever is earlier ]
  • Describe the duration of treatment with Ceftazidime avibactam in days [ Time Frame: Till 14 Days/ End of the treatment with Ceftazidime-Avibactam, whichever is earlier ]
  • Percentage of patients who have been administered various combination antibiotic regimens along with ceftazidime avibactam [ Time Frame: Till 14 days/ end of treatment with Ceftazidime-avibactam, whichever is earlier ]
  • Describe any prior antimicrobial therapy administered in the 90 days prior to current admission [ Time Frame: At baseline ]
  • Describe the gram negative organisms identified and the susceptibility to ceftazidime -avibactam along with molecular typing [ Time Frame: At baseline ]
  • Describe the in-hospital length of stay (LOS) in days in patients with infections treated by ceftazidime-avibactam [ Time Frame: Up to 30 days post treatment completion with Ceftazidime- Avibactam death or discharge; whatever is first ]
  • Describe the length of stay in ICU in days in patients with infections treated by ceftazidime-avibactam [ Time Frame: Up to 30 days post treatment completion with Ceftazidime- Avibactam death or discharge; whatever is first. ]
  • Percentage of various healthcare resource utilization in patients with infections treated by ceftazidime-avibactam [ Time Frame: Up to 30 days post treatment completion with Ceftazidime- Avibactam death or discharge; whatever is first. ]
  • Determine the incidence of recurrent infections during the hospital stay, including re-infection and relapse [ Time Frame: Up to 30 days post treatment completion with Ceftazidime- Avibactam, death or discharge; whatever is first. ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Active, not recruiting
Estimated Enrollment
 (submitted: November 12, 2020)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 1, 2021
Estimated Primary Completion Date May 1, 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 information is only displayed when the study is recruiting subjects
Listed Location Countries India
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2021