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Impact of Antimicrobial Stewardship Program

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ClinicalTrials.gov Identifier: NCT04039152
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Neveen Hassan, Assiut University

Tracking Information
First Submitted Date July 29, 2019
First Posted Date July 31, 2019
Last Update Posted Date August 15, 2019
Actual Study Start Date November 1, 2018
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2019)
  • Mortality rate in each group [ Time Frame: 18 month ]
    Number of deaths
  • Average Length of hospital stay in each group [ Time Frame: 18 month ]
    In days
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04039152 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 13, 2019)
Total Antibiotics consumption [ Time Frame: 18 month ]
in the form of defined daily doses
Original Secondary Outcome Measures
 (submitted: July 29, 2019)
Total Antbiotic consumption [ Time Frame: 18 month ]
in the form of defined daily doses
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of Antimicrobial Stewardship Program
Official Title Impact of Antimicrobial Stewardship Program on Antibiotics Use in Neonatal Intensive Care Unit at Assiut University Children's Hospital
Brief Summary Establishing an antibiotic policy based on the local culture sensitivity records to ensure rational use of antibiocs, then measure the clinical and economic impact of this local antibiotic policy.
Detailed Description

Study Objective

  • The Ultimate aims of antimicrobial stewardship program are to improve antimicrobials efficacy, minimize their adverse effects and limit antimicrobial resistance.
  • The aim of this study is to measure the clinical & economic impact of antimicrobial stewardship program interventions.

Methodology

Study Design:

• Prospective-audit with feedback program strategy (Single-center, prospective, pre- and post-intervention study).

Setting:

• This study will be conducted in Neonatal Intensive Care Unit of Assiut University Children's Hospital, Assiut University, Assiut, Egypt.

Timing:

• 12- 18 months.

Ethical Approval:

• This study approved by the University Ethics Medical Committee. Informed consent is unnecessary since antimicrobial stewardship program interventions represent a part of routine clinical practice. Patients records will be identified by coded numbers to maintain privacy.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Neonates taking antbiotics admitted to NICU
Condition Blood Stream Infections
Intervention Other: Clinical pharmacists recommendations to optimize antibiotics use
Optimal dosing, drug bug mismatch
Study Groups/Cohorts
  • Pre- interventions group
    Without clinical pharmacists recommendations to optimize antibiotics use
  • Post - interventions group
    interventions include clinical pharmacists recommendations to optimize antibiotics use
    Intervention: Other: Clinical pharmacists recommendations to optimize antibiotics use
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 Recruiting
Estimated Enrollment
 (submitted: July 29, 2019)
400
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients admitted to the Neonatal intensive care unit (NICU) during study period and administered any antibiotic were included in the study.

Exclusion Criteria:

  • Patients with renal or hepatic impairment.
Sex/Gender
Sexes Eligible for Study: All
Ages up to 30 Days   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Neveen Abdelaal 00201005647073 niveeneltonsy@gmail.com
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT04039152
Other Study ID Numbers AssiutUU
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Participant data will not be shared
Responsible Party Neveen Hassan, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date August 2019