Comparing efficacy and safety of Meropenem/Ampicillin-sulbactam and Meropenem/Colistin in treatment of ventilator associated pneumonia due to resistant gram negative microorganisms
Objective: The main goal of this study is to compare the safety and efficacy of ampicillin/sulbactam and colistin in the treatment of ventilator-associated pneumonia (VAP) due to multidrug resistant gram negative organisms.
Design: Randomized, single-blind, interventional, multicenter, phase III clinical trial
This is a prospective study in adult (18-65 years old) critically ill patients with VAP. 40 patients patients hospitalized in ICU with ventilator-associated pneumonia (VAP) due to multidrug resistant gram negative organisms, will be recruited. Patients are randomly assigned to receive meropenem/ampicillin/sulbactam (2 g Q 8h/3 g Q 4h) or meropenem/colistin (2 g Q 8h/9 MU stat then 4.5 MU BD) intravenously. Dosage was adjusted according to creatinine clearance. The radiological findings, laboratory data and microbiological results at baseline, 48h and 2 weeks after antibiotic therapy are used for the evaluation of the regimens efficacy. Incidence rates of adverse drug reactions durig the study phase are considered for safety evaluation of the antibiotic regimens.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509213449N19
Registration date:2015-12-04, 1394/09/13
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-04, 1394/09/13
Registrant information
Name
Hossein Khalili
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4715
Email address
khalilih@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tehran University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing efficacy and safety of Meropenem/Ampicillin-sulbactam and Meropenem/Colistin in treatment of ventilator associated pneumonia due to resistant gram negative microorganisms
Public title
Antibiotic regimens for treatment of resistant pneumonia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients (18-65 years old) with ventilator-associated pneumonia due to multidrug resistant gram negative organisms will be included.
Exclusion criteria: Infection with gram negative organism with meropenem MIC > 8 μg/ml; Infection with gram negative organism with colistin MIC > 2 μg/ml; Patients with an allergy to each of two antibiotic regimens
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Ghods Ave. Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-10-03, 1394/07/11
Ethics committee reference number
IR.TUMS.REC.1394.867
Health conditions studied
1
Description of health condition studied
Pneumonia
ICD-10 code
J15.0
ICD-10 code description
Pneumonia due to Klebsiella pneumoniae
2
Description of health condition studied
Pneumonia
ICD-10 code
J15.1
ICD-10 code description
Pneumonia due to Pseudomonas
3
Description of health condition studied
Pneumonia
ICD-10 code
J15.6
ICD-10 code description
Pneumonia due to other aerobic Gram-negative bacteria
Primary outcomes
1
Description
Clinical response of pneumonia to treatment regimen
Timepoint
At day 2, day 7, day 17
Method of measurement
Evaluation of fever, blood cells, pulmonary secretions, oxygenation status
2
Description
Microbiological response to treatment regimen
Timepoint
At day 2, day 7
Method of measurement
Tracheal secretion culture
3
Description
Clinical outcome of patients
Timepoint
day 7, day 14, day 21, day 28
Method of measurement
28 days patients' follow-up
4
Description
Duration of ICU stay
Timepoint
day 7, day 14, day 21, day 28
Method of measurement
28 days patients' follow-up
Secondary outcomes
empty
Intervention groups
1
Description
Colistin 9MIU loading dose as iv infusion over 1 hour then 4.5MIU every 12 hour as iv infusion over 1 hour+Meropenem 2g every 8 hour as iv infusion over 3 hours for 14 days
Category
Treatment - Drugs
2
Description
Ampicillin-Sulbactam 3g every 4 hour as iv infusion over 1 hour and Meropenem 2g every 8 hour as iv infusion over 3 hours for 14 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Blvd.
City
Tehran
2
Recruitment center
Name of recruitment center
Valiasr hospital
Full name of responsible person
Hossein Khalili
Street address
Keshavarz Blvd.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Tehran University of Medical Sciences
Full name of responsible person
Masoud Yunesian
Street address
Vice Chancellor for Research, Tehran University of Medical Sciences, Ghods Ave., Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Tehran 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm.D, PHD
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6658 1598
Fax
Email
khalilih@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Hossein Khalili
Position
Pharm.D, PHD
Other areas of specialty/work
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 6658 1598
Fax
Email
khalilih@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)