NCT05002647

Brief Summary

A retrospective cohort study to explore the association between clinical pharmacists' interventions and antibiotic consumption through the use of the medical electronic reports and to identify mortality and cost savings in hospital infectious disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,601

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

December 27, 2024

Status Verified

August 1, 2021

Enrollment Period

4 months

First QC Date

August 7, 2021

Last Update Submit

December 23, 2024

Conditions

Keywords

clinical pharmacistantibiotic consumptionantibiotic usecost-saving

Outcome Measures

Primary Outcomes (3)

  • Antimicrobial consumption

    consumption of antimicrobials (defined daily doses / 100 patient-days)

    2 years

  • Days of therapy (DOT)

    Number of days of each antimicrobial received for therapy

    2 years

  • Length of therapy(LOT)

    The number of days a patient takes an antibacterial drug, regardless of the number of different medications

    2 years

Secondary Outcomes (4)

  • cost savings

    2 years

  • Mortality rate

    2 years

  • Antimicrobial resistance

    2 years

  • The incidence of adverse reaction of antimicrobial

    2 years

Study Arms (3)

exposure group

Data from electronic clinical pharmacist records of two infectious disease hospitals

Other: NO intervention

Non-exposure group A

Data from medical records of the hospital with no clinical pharmacy.

Other: NO intervention

Non-exposure group B

Data from a medical record of the hospital with clinical pharmacy, but the department did not cover by the clinical pharmacy

Other: NO intervention

Interventions

There is no intervention

Non-exposure group ANon-exposure group Bexposure group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who administered antimicrobials

You may qualify if:

  • All inpatient with infectious disease (disorders caused by organisms as (bacteria, viruses, fungi, or parasites).

You may not qualify if:

  • Any other cause of hospital admission other than infectious disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ministers of health

Alexandria, 22511, Egypt

Location

Related Publications (3)

  • Karakonstantis S, Kalemaki D. Antimicrobial overuse and misuse in the community in Greece and link to antimicrobial resistance using methicillin-resistant S. aureus as an example. J Infect Public Health. 2019 Jul-Aug;12(4):460-464. doi: 10.1016/j.jiph.2019.03.017. Epub 2019 Apr 10.

    PMID: 30981652BACKGROUND
  • Dyar OJ, Huttner B, Schouten J, Pulcini C; ESGAP (ESCMID Study Group for Antimicrobial stewardshiP). What is antimicrobial stewardship? Clin Microbiol Infect. 2017 Nov;23(11):793-798. doi: 10.1016/j.cmi.2017.08.026. Epub 2017 Sep 4.

    PMID: 28882725BACKGROUND
  • Ourghanlian C, Lapidus N, Antignac M, Fernandez C, Dumartin C, Hindlet P. Pharmacists' role in antimicrobial stewardship and relationship with antibiotic consumption in hospitals: An observational multicentre study. J Glob Antimicrob Resist. 2020 Mar;20:131-134. doi: 10.1016/j.jgar.2019.07.009. Epub 2019 Jul 16.

    PMID: 31323427BACKGROUND

Study Officials

  • Amira zidane

    Ministry of Health and Population, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2021

First Posted

August 12, 2021

Study Start

September 15, 2021

Primary Completion

January 1, 2022

Study Completion

March 10, 2022

Last Updated

December 27, 2024

Record last verified: 2021-08

Locations