Protocol summary

Study aim
Comparison of the clinical effectiveness of two different regimens of the extended infusion of Meropenem in critically ill patients with hospital-acquired or ventilator-associated pneumonia
Design
In this research, which designed a parallel single-blind randomized clinical trial, 62 eligible patients randomize in two subgroups of APACHE II ≥20, APACHE II <20, to receive one of the interventions. A code is allocated to each participants.
Settings and conduct
This study is conducted in the intensive care unit of Imam Khomeini educational hospital in Sari between 2018-19. The person who does the meropenem MIC test is blind to the interventions.
Participants/Inclusion and exclusion criteria
Critically ill patients who are admitted to the intensive care unit and suffered from hospital-acquired or ventilator-associated pneumonia had an indication to receive meropenem because probable infection with multi-drug resistance gram-negative bacteria enrolled in the study. Patients with renal dysfunction and in risk of developing seizure are excluded from the study.
Intervention groups
The interventions arm receive the infusion of Meropenem 3 g TDS, and the control arm receive the infusion of Meropenem 2 g TDS.
Main outcome variables
Clinical success ( Time Frame: 7 days ) defined as the following, all measured at 7 days: - Patient alive - Complete or relative depletion of pneumonia sign and symptoms (leukocytosis, fever, sputum, dyspnea and tachypnea) - Systolic blood pressure >90 mmHg without need for vasopressor support - Stable or improved SOFA score, define as: .for baseline SOFA ≥ 3: a decrease of at least 30%; .for baseline SOFA <3: stable or decreased SOFA score -PaO2/FiO2 ratio stable or improved

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100107003014N19
Registration date: 2018-04-27, 1397/02/07
Registration timing: registered_while_recruiting

Last update: 2018-04-27, 1397/02/07
Update count: 0
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the clinical effectiveness of the two different doses of Meropenem in critically ill patients with hospital acquired or ventilator associated pneumonia: a randomized single-blind clinical trial
Public title
Comparison of the clinical effectiveness of the two different doses of Meropenem in pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Critically ill patients admitted to the intensive care unit Patients with hospital acquired or ventilator associated pneumonia Indication to receive Meropenem between 18 and 70 years old
Exclusion criteria:
Pregnant or breastfeeding women Acute or chronic renal failure Epilepsy or history of siezure CNS infection Immune-compromised or using immunomodulator agents Known allergy to carbapenems
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with sealed envelops
Blinding (investigator's opinion)
Single blinded
Blinding description
،he investigator who does the meropenem MIC test on bacteria which had been cultured from patients' sputum samples is blind to which patients receive which interventions.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moalem Sq.
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.MAZUMS.REC.97.82

Health conditions studied

1

Description of health condition studied
Bacterial pneumonia
ICD-10 code
J15
ICD-10 code description
Bacterial pneumonia, not elsewhere classified

Primary outcomes

1

Description
Clinical success
Timepoint
7 days after intervention
Method of measurement
Collecting data forum

Secondary outcomes

1

Description
All-cause mortality
Timepoint
7, 14 and 28 days after intervention
Method of measurement
Data collecting form

2

Description
Clinical success with modification
Timepoint
7 and 14 days after intervention
Method of measurement
Data collecting form

3

Description
Time to weaning
Timepoint
28 days
Method of measurement
Data collecting form

4

Description
Time to intensive care unit discharge
Timepoint
28 days
Method of measurement
Data collecting form

5

Description
Time to hospital discharge
Timepoint
28 days
Method of measurement
Data collecting form

Intervention groups

1

Description
Intervention group: Meropenem 3 gram every 8 hours, 3 hours extended infusion for 7 days
Category
Treatment - Drugs

2

Description
Control group: Meropenem 2 gram every 8 hours, 3 hours extended infusion for 7 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Shahram Ala
Street address
Razi Street
City
Sari
Province
Mazandaran
Postal code
3313148166
Phone
+98 11 3336 1700
Email
info@emamhospital.ir
Web page address
http://imamhospital.mazums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Vice chancellor for research and Technology of Mazandaran University of Medical Sciences, Moallem square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shahram Ala
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 18 Khazar Abad Road, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Fax
Email
sala@mazums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shahram Ala
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 18 Khazar Abad Road, Sari, Mazandaran, Iran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Fax
Email
sala@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shahram Ala
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 18 Khazar Abad Road
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Fax
Email
sala@mazums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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