Investigation of pharmacokinetic and clinical outcomes of various meropenem regimens in patients with ventilator-associated pneumonia and augmented renal clearance
Investigation of pharmacokinetic and clinical outcomes of various meropenem regimens in patients with ventilator-associated pneumonia and augmented renal clearance
Design
Randomized controlled clinical trial, phase 3, 60 patients. In order to randomization, online randomization website is used.
Settings and conduct
Study is conducted in ICU ward of Loghman Hakim Hospital. Patients with pneumonia receiving meropenem and high risk for ARC are recruited and creatinine clearance is measured using patient's urine collected during 8 hours in days 1,3,5.
Participants/Inclusion and exclusion criteria
patients with augmented renal clearance and ventilator associated pneumonia
Intervention groups
receiving 1 mg meropenem TDS infused over 6 hours - receiving 2 mg meropenem TDS infused over 3 hours
Main outcome variables
FT>MIC in at least 50% of dose interval time; resolution of fever, leukocytosis, decline in secretions, oxygenation improvement, no new pulmonary infiltration, no new positive tracheal culture, decrease in intubation time and hospitalization, ESR, CRP, lactate serum level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130917014693N12
Registration date:2020-09-29, 1399/07/08
Registration timing:registered_while_recruiting
Last update:2020-09-29, 1399/07/08
Update count:0
Registration date
2020-09-29, 1399/07/08
Registrant information
Name
Zahra Sahraei
Name of organization / entity
Faculty of pharmacy, Shahid beheshti university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 3704
Email address
z.sahraei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-21, 1399/03/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of pharmacokinetic and clinical outcomes of various meropenem regimens in patients with ventilator-associated pneumonia and augmented renal clearance
Public title
Various types of meropenem administration in patients with VAP snd ARC
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive or probable diagnosis of VAP based upon CPIS
Patients with high probability for ARC according to ARC scoring systems. (score>7)
Patients receiving meropenem
Patient`s serum creatinine level less than 1.3 mg/dL
Patients >18 years old
Exclusion criteria:
Patients sensitive to meropenem
Infection due to gram-positive bacteria
Patients diagnosed with acute kidney injury
Patients non-responsive to meropenem during the first 7 days of treatment and therefore needing medication change
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
6
2 blood samples on days 2,3,5 of treatment
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method is used and 10 blocks consisting of 6 patients are generated through online randomization website. In each block 2 patients are allocated to standard group (1 mg meropenem TDS, infused over 3 hours) and 4 patients are allocated to intervention groups; 2 patients receiving 2 mg meropenem TDS, infused over 3 hours and 2 patients receiving 1 mg meropenem TDS, infused over 6 hours. Then, sampling will be done through individual sampling method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Sciences
Street address
3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway
City
tehran
Province
Tehran
Postal code
1983963113
Approval date
2019-07-14, 1398/04/23
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1398.095
Health conditions studied
1
Description of health condition studied
ventilator associated pneumonia
ICD-10 code
J95.851
ICD-10 code description
Ventilator associated pneumonia
Primary outcomes
1
Description
ft>MIC in at least 50% of dose time interval
Timepoint
days 2,3,5 during meropenem administration
Method of measurement
measuring meropenem plasma concentration by HPLC
Secondary outcomes
1
Description
improvement in clinical factors
Timepoint
daily
Method of measurement
observation
Intervention groups
1
Description
Control group: receiving 1 mg meropenem TDS infused over 3 hours