NCT05223400

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2022

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

February 3, 2023

Status Verified

February 1, 2023

Enrollment Period

1 month

First QC Date

January 6, 2022

Last Update Submit

February 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • the number of prescriptions with appropriate indications of clindamycin will be counted during the retrospective observation of all prescriptions

    appropriateness of clindamycin indication will be determined according to IDSA guidelines.

    1 month

Secondary Outcomes (5)

  • the number of prescriptions with duplication of therapy with clindamycin will be counted during the retrospective observation of all prescriptions

    1 month

  • the number of patients who had diarrhea as a main side effect of clindamycin

    1 month

  • the number of patients who had severe drug interactions with clindamycin

    1 month

  • Total clindamycin DDD defined daily doses and clindamycin defined daily doses per 1000 patients days.

    1 month

  • to calculate the total cost of clindamycin.

    1 month

Interventions

it is a clindamycin use evaluation study

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Mdicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Bacterial Infections

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LincomycinLincosamidesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosidesCarbohydrates

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
supervisor of clinical pharmacy unit in Alexandria Main University Hospital

Study Record Dates

First Submitted

January 6, 2022

First Posted

February 4, 2022

Study Start

March 1, 2022

Primary Completion

April 1, 2022

Study Completion

April 1, 2022

Last Updated

February 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Locations