Antibiotic Regimens Tailored by Clinical Pharmacist Suppored by Intensivist Enhanced Rational Use of Antibiotics

November 5, 2022 updated by: Ibrahim Mabrouk Ibrahim, University of Alexandria
adding pharmaceutical services to patient care and changing the professional activity of pharmacists from drug-focused to patient-oriented care,in the current study, clinical pharmacists will be assigned to monitor pharmacotherapy regimens, participate in patient care, and cooperate in educating the staff and evaluating care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

During the intervention period, the pharmacist attended daily unit rounds with ICU intensivist with a focus on optimization of antibiotic regimens. Pharmacist consultative services were also available by phone calls 24 hours x 7 days if needed. For every patient surgical prophylactic antibiotic initiated immediately before surgery and continued for 48 hours following surgery. Antibiotic therapy had given as either directed or empiric. Directed therapy was defined as treatment of a documented infection based on culture and sensitivity. Empiric therapy was defined as any antibiotic therapy administered when no documented infection was present, and the patient had clinically suspected infection following surgery. Empiric antibiotic administration was required in majority of our SICU patients. Antibiotics had given after exclusion of allergy by history and intradermal sensitivity test.

Study Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 23541
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All the information including the age, gender, comorbidity (presented as Charlson comorbidity index score ), surgical procedure done, patients' temperature, white blood cells count, type of infection (e.g., pneumonia, wound infection, Urinary tract infection,…..), prescribed antibiotics regimen either they will use empirical or based on cultures, results of culture sensitivity tests, length of stay, and mortality of patients

Description

Inclusion Criteria:

  • all admitted patients to the ICU between age 18-80 years old

Exclusion Criteria:

  • Patient admitted for less than 24 hours (including deaths and transfers) will be excluded from the study.

Pediatric patients weighted less than kilograms.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group c
Patients admitted from June 9, 2020 to june 31, 2021.
Other: Clinical pharmacy sharing in the patient care regimen
antibiotic regimens will be directed by a trained clinical pharmacist recommendation and supported by intensivist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antibiotics consumption
Time Frame: 1 year
consumption will be counted as number of defined daily doses (DDD), expressed as DDD per 100 patient-days
1 year
Average length of stay
Time Frame: 1 year
the average number of days that patients spent in SICU.
1 year
Mortality rate
Time Frame: 1 year
The number of deaths of patients admitted to SICU, divided by the number of admissions.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2020

Primary Completion (Actual)

December 5, 2020

Study Completion (Actual)

December 25, 2020

Study Registration Dates

First Submitted

May 29, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 5, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 203 (UNIMIB Ethic Commettee)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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