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

Infection, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05223400
• Other study ID #: 0305292
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: April 1, 2022

Study information

• Verified date: February 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: April 1, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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).

Related Conditions & MeSH terms

• Bacterial Infections
• Infection, Bacterial

Intervention

Drug:
• Clindamycin Injection
it is a clindamycin use evaluation study

Locations

Country	Name	City	State
Egypt	Faculty of Mdicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the number of prescriptions with duplication of therapy with clindamycin will be counted during the retrospective observation of all prescriptions	duplication of therapy means prescribing of clindamycin concurrently with another antibiotic to target the same microorganism.	1 month
Secondary	the number of patients who had diarrhea as a main side effect of clindamycin	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
Secondary	the number of patients who had severe drug interactions with clindamycin	in the study the number of patients who severe clindamycin drugs interactions will be counted during the retrospective observation of all prescriptions	1 month
Secondary	Total clindamycin DDD defined daily doses and clindamycin defined daily doses per 1000 patients days.	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
Secondary	to calculate the total cost of clindamycin.	The cost of clindamycin treatment courses of all patients will be calculated in the Egyptian pound	1 month