Protocol summary

Summary
This study was done to assess the effect of clarithromycin in preventing ventilator-associated pneumonia. A total of 60 patients older than 18 years who were admitted in ICU ward were recruited and randomly assigned to receive either placebo or clarithromycin. Those with neutropenia, AV block and HIV infection were excluded from the study. Patients who had positive culture of Tracheobronchial smears and new consolidation or infiltration in chest radiograph were diagnosed with ventilator associated pneumonia. The frequency of pneumonia was compared between two groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014121620341N1
Registration date: 2014-12-31, 1393/10/10
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-12-31, 1393/10/10
Registrant information
Name
Mohammad Reza Mirjalili
Name of organization / entity
Shahid Sadoughi University of Medcal Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3725 8770
Email address
dr.mirjalili@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2013-05-04, 1392/02/14
Expected recruitment end date
2013-12-07, 1392/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of clarithromycin in preventing ventilator associated pneumonia
Public title
Does administration of clarithromycin prevent pneumonia due to ventilator use?
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: ICU admission Exclusion criteria: Neutropenia (Absolute Neutrophil Count less than 500 cells/µl); HIV infection; second or three degree atrioventricular (AV) block; Receiving oral corticosteroids in the past month
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of Shahid sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Sciences, Yazd, Iran
City
Yazd
Postal code
Approval date
2012-02-13, 1390/11/24
Ethics committee reference number
2483

Health conditions studied

1

Description of health condition studied
ventilator-associated pneumonia
ICD-10 code
J18.9
ICD-10 code description
Pneumonia, unspecified

Primary outcomes

1

Description
pneumonia
Timepoint
48 hours
Method of measurement
Tracheobronchial smear culture, Colony forming units more than 10000000

Secondary outcomes

1

Description
َAPACHI score
Timepoint
day 1, 5, and 10
Method of measurement
physical exam

Intervention groups

1

Description
Intervention: oral clarithromycin 500 mg/BD Control: placebo
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Mohammad Reza Mirjalili
Street address
Shahid Sadoughi Hospital, Riazi sq., Yazd
City
Yazd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mohammad Reza Mirjalili (Dean of the University)
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar sq, Yazd, Iran
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mohammad Reza Mirjalili
Position
ICU fellowship/faculty member
Other areas of specialty/work
Street address
Shahid Sadoughi hospital, Riazi sq, Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 3725 8771
Fax
Email
dr.mirjalili@ssu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mohammad Reza Mirjalili
Position
ICU fellowship/faculty member
Other areas of specialty/work
Street address
Shahid Sadoughi hospital, Riazi sq., Yazd, Iran
City
Yazd
Postal code
Phone
+98 35 3725 8771
Fax
Email
dr.mirjalili@ssu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Mohammad Reza Mirjalili
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
dr.mirjalili@ssu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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