Investigating and comparing the therapeutic outcomes of two treatment regimens of cholestin instillation (through the bronchoscope) versus standard treatment in patients with ventilator-associated pneumonia (VAP) with resistant gram-negative bacilli.
Determination and comparison of mortality in two treatment regimens of cholestin instillation (via bronchoscope) versus standard treatment (cloestine nebulizer) in patients with ventilator-associated pneumonia (VAP) with resistant gram-negative bacilli.
Design
Clinical trial, with parallel groups, randomized, phase 3 on 48 patients. Random numbers were used for randomization.
Settings and conduct
The study will be conducted at Imam Khomeini Hospital in Tehran.
Participants/Inclusion and exclusion criteria
Patient consent, patients aged 18 to 75, under mechanical ventilation and eligible for the diagnosis of ventilator-associated pneumonia.
Intervention groups
Clostin instillation: This group of lung involvement areas is identified by fiberoptic bronchoscopy (based on the zones or segments of the lung identified in the radiology image or based on the location of secretions under direct view with a bronchoscope). These patients, in addition to the usual treatment (venous meropenem 2 grams three times a day and intravenous cholestin 4.5 million units twice a day, whose dose will be adjusted according to kidney function). After suctioning the secretions, the tip of the bronchoscope is wedged in the affected area and 300,000 units of Cleistin is prescribed for each affected lung segment with a concentration of 1,000,000 units per milliliter for three days.Cholestine nebulizer group: In addition to intravenous meropenem 2 grams three times a day and intravenous cholestin 4.5 million units twice a day and a cholestin nebulizer of 2,000,000 units three times a day for at least three days.
Main outcome variables
Mortality of patients and the number of days of hospitalization in intensive care units
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120527009886N3
Registration date:2023-04-11, 1402/01/22
Registration timing:prospective
Last update:2023-04-11, 1402/01/22
Update count:0
Registration date
2023-04-11, 1402/01/22
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
02161192663-02161192828
Email address
mohammady_mm@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-18, 1402/01/29
Expected recruitment end date
2023-05-19, 1402/02/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the therapeutic outcomes of two treatment regimens of cholestin instillation (through the bronchoscope) versus standard treatment in patients with ventilator-associated pneumonia (VAP) with resistant gram-negative bacilli.
Public title
Investigating and comparing the therapeutic outcomes of two regimens of cholestin therapy through a bronchoscope versus standard treatment in patients with lung infection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with ventilator-associated pneumonia
Age between 18 and 75 years
Patients who developed pulmonary infection with gram-negative bacilli resistant to several antibiotic drugs after 48 hours of intubation.
Exclusion criteria:
Age older than 75 or younger than 18 years
Patients with adult respiratory distress syndrome (ARDS) according to the Berlin criteria
P/F ratio less than 100
Septic shock requires a dose of norepinephrine with a dose greater than 0.25 Mcg/KG/MIN
Patients with infection with other microorganisms
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
A computer-generated randomization sequence will be used to allocate eligible participants to either the bronchoscopy group or the standard treatment group. The sequence will be generated by a statistician not involved in the study, using a random number generator with varying block sizes to ensure balance between the two groups. The allocation will be concealed in opaque sealed envelopes, and the study personnel responsible for enrolling participants will open the envelopes sequentially and allocate the participant to the corresponding group. To further reduce the possibility of allocation bias, neither the participants nor the study personnel will be informed of the allocation sequence until after the participant has given informed consent and baseline measurements have been obtained.
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
Teharn University of medical sciences
Street address
Tehran Province, Tehran, District 6, Pour Sina St, P94V+8MF, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Approval date
2023-04-02, 1402/01/13
Ethics committee reference number
IR.TUMS.IKHC.REC.1402.004
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
Mortality rate
Timepoint
After the start of treatment until the discharge or death of the patient
Method of measurement
Questionnaire
Secondary outcomes
1
Description
The number of days hospitalized in the intensive care unit
Timepoint
After initiation of treatment until discharge or death from the intensive care unit
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Instillation Bronchoscopy
Category
Treatment - Drugs
2
Description
Control group: Clostin nebulizer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hopsital
Full name of responsible person
Mostafa Mohammadi
Street address
Keshavarz BlvD, Dr Qarib St
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
mohammady_mm@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Deputy of Research and Technology.
Street address
North Kargar St., intersection of Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8889 6696
Email
icedu@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Mohammadi
Position
Professor of critical care
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Blvd., Dr. Gharib St
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
0098.21.61190
Email
mohammady_mm@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Mohammadi
Position
Professor of critical care
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Blvd., Dr. Gharib St
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
0098.21.61190
Email
mohammady_mm@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Mohammadi
Position
Professor of critical care
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Keshavarz Blvd., Dr. Gharib St
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
0098.21.61190
Email
mohammady_mm@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
No - There is not a plan to make this available
Title and more details about the data/document
Data will be coded and will be shared.
When the data will become available and for how long
Starting in September 2023
To whom data/document is available
People working in academic institutions
Under which criteria data/document could be used
Email should be sent from an academic institutions and 1 month will be lasted from sending email and getting data.
From where data/document is obtainable
Email Morteza Foroomandi
What processes are involved for a request to access data/document
Email should be sent from an academic institutions and 1 month will be lasted from sending email and getting data.