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Trial record 33 of 752 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

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

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.

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.


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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 : November 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 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
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.

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 ClinicalTrials.gov identifier (NCT number): NCT04039152


Contacts
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Contact: Neveen Abdelaal 00201005647073 niveeneltonsy@gmail.com

Locations
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Egypt
Assiut University Recruiting
Assiut, Egypt, 71511
Contact: Neveen Abdelaal    00201005647073    niveeneltonsy@gmail.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Neveen Hassan, Principle investigator, Assiut University
ClinicalTrials.gov Identifier: NCT04039152     History of Changes
Other Study ID Numbers: AssiutUU
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
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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Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents