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Impact of Antimicrobial Stewardship Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04039152
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 21, 2020
Information provided by (Responsible Party):
Neveen Hassan, Assiut University

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.

Condition or disease Intervention/treatment
Blood Stream Infections Other: Clinical pharmacists recommendations to optimize antibiotics use

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.


Study Design:

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


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


• 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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Impact of Antimicrobial Stewardship Program on Antibiotics Use in Neonatal Intensive Care Unit at Assiut University Children's Hospital
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort Intervention/treatment
Pre- interventions group
Without clinical pharmacists recommendations to optimize antibiotics use
Post - interventions group
interventions include clinical pharmacists recommendations to optimize antibiotics use
Other: Clinical pharmacists recommendations to optimize antibiotics use
Optimal dosing, drug bug mismatch

Primary Outcome Measures :
  1. Mortality rate in each group [ Time Frame: 18 month ]
    Number of deaths

  2. Average Length of hospital stay in each group [ Time Frame: 18 month ]
    In days

Secondary Outcome Measures :
  1. Total Antibiotics consumption [ Time Frame: 18 month ]
    in the form of defined daily doses

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Neonates taking antbiotics admitted to NICU

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 Who have no antibiotics during their length of stay

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04039152

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Contact: Neveen Abdelaal 00201005647073

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Assiut University Recruiting
Assiut, Egypt, 71511
Contact: Neveen Abdelaal    00201005647073   
Sponsors and Collaborators
Assiut University
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Responsible Party: Neveen Hassan, Principle investigator, Assiut University Identifier: NCT04039152    
Other Study ID Numbers: AssiutUU
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participant data will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents