Drug Use Evaluation of Clindamycin in Critical Care Units in Alexandria Main University Hospital

February 2, 2022 updated by: Heba Shaker, Alexandria University

Drug Use Evaluation Study of Clindamycin in Critical Care Units in Alexandria Main University Hospital

Irrational use of antibiotics is a one of the main health system problems,it leads to antibiotic resistance,increasing antibiotics side effects and the total cost. This study is a medication use evaluation study aims to evaluate intravenous clindamycin prescribing practice in critical care units in Alexandria Main University Hospital.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

99

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
        • Faculty of Mdicine
        • Contact:

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 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adult patients admitted to critical care units and on clindamycin emperical therapy .

Description

Inclusion Criteria:

  • Adults 18 years old or more .
  • Patients on clindamycin as an empirical treatment.
  • Patients started clindamycin as an emperical treatment in other departments but the physician approved to continue it in critical care.

Exclusion Criteria:

  • Children (less than 18 years old)
  • Patients started clindamycin as a defenitive treatment (based on microbiological culture results).

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of prescriptions with appropriate indications of clindamycin will be counted during the retrospective observation of all prescriptions
Time Frame: 1 month
appropriateness of clindamycin indication will be determined according to IDSA guidelines.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of prescriptions with duplication of therapy with clindamycin will be counted during the retrospective observation of all prescriptions
Time Frame: 1 month
duplication of therapy means prescribing of clindamycin concurrently with another antibiotic to target the same microorganism.
1 month
the number of patients who had diarrhea as a main side effect of clindamycin
Time Frame: 1 month
diarrhea is a main side effect of clindamycin so in the study the number of patients who had diarrhea will be counted during the retrospective observation of all prescriptions
1 month
the number of patients who had severe drug interactions with clindamycin
Time Frame: 1 month
in the study the number of patients who severe clindamycin drugs interactions will be counted during the retrospective observation of all prescriptions
1 month
Total clindamycin DDD defined daily doses and clindamycin defined daily doses per 1000 patients days.
Time Frame: 1 month
Defined daily doses measurement of a drug is an indicator put by WHO , it indicates the consumption of this drug in a hospital or a department and defined daily doses per 1000 patients days indicates the consumption of this drug in relation to the total number of patients in a certain period of time.
1 month
to calculate the total cost of clindamycin.
Time Frame: 1 month
The cost of clindamycin treatment courses of all patients will be calculated in the Egyptian pound
1 month

Collaborators and Investigators

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

Sponsor

Alexandria University

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 (ANTICIPATED)

March 1, 2022

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

February 2, 2022

First Posted (ACTUAL)

February 4, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 4, 2022

Last Update Submitted That Met QC Criteria

February 2, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0305292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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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