Safety and Effectiveness of Piperacillin/Tazobactam (Zosyn®) in the Treatment of Pediatric Hospital Acquired Pneumonia (HAP): A Retrospective Cohort Study

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS8352
• Study ID:
  50654
• Official title and acronym:
  Safety and Effectiveness of Piperacillin/Tazobactam (Zosyn®) in the Treatment of Pediatric Hospital Acquired Pneumonia (HAP): A Retrospective Cohort Study
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective cohort study to study the safety profile and effectiveness of Piperacillin/Tazobactam in pediatric patients treated for HAP. The study will utilize data from the Paediatric Health Information System (PHIS) database and medical charts.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:15/11/2013

Actual:15/11/2013

Study start date

Planned:02/03/2015

Actual:02/03/2015

Date of final study report

Planned:30/04/2019

Actual:30/04/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only