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Evaluation of the Effect of Oral fosfomycin Addition on Treatment of Patients with Klebsiella pneumoniae Carbapnemase Infections with Colistin

Protocol summary

Study aim
Evaluation of the Effect of Oral Phosphomycin Addition on Treatment of Patients with Klebsiella pneumoniae Carbapnemase Infections with Colistin
Design
A clinical trial study in which patients with Klebsiella pneumoniae carbapenemase infection diagnosed by reliable culture and admitted to the infectious ward of Vali Asr Hospital are included. In this study 62 patients were randomly divided into fosfomycin + cholestine and cholestine groups.The trial phase is 3
Settings and conduct
A clinical trial study in which patients with Klebsiella pneumoniae carbapenemase infection diagnosed by reliable culture and admitted to the infectious ward of Vali Asr Hospital are included. In this study 62 patients were randomly divided into fosfomycin + cholestine and cholestine groups .The study is open label
Participants/Inclusion and exclusion criteria
Patients with Klebsiella Pneumoniae Carbapenemase infection diagnosed by reliable culture and admitted to the infectious ward of Vali Asr Hospital are studied.Exclusion criteria included : Allergy to fosfomycin- Patients with renal failure - Hemodialysis Patients - Under 12 years age- Patients who have received antibiotics affecting KPC for the past 72 hours.
Intervention groups
Intervention group: In the first 7 days of treatment, 31 patients will receive colistin (3 million units of TDS injectable colistin) along with oral fosfomycin (3 g per 12-hour dose). The total duration of treatment is 14 days.
Main outcome variables
Leukocytosis - mute the fever -Symptoms Remedy - Negative urine culture

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191104045328N1
Registration date: 2019-11-10, 1398/08/19
Registration timing: prospective

Last update: 2019-11-10, 1398/08/19
Update count: 0
Registration date
2019-11-10, 1398/08/19
Registrant information
Name
Amin Haji seyyed hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 7583
Email address
amin.medstu@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-11, 1398/09/20
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effect of Oral fosfomycin Addition on Treatment of Patients with Klebsiella pneumoniae Carbapnemase Infections with Colistin
Public title
Evaluation of the Effect of Oral fosfomycin Addition on Treatment of Patients with Klebsiella pneumoniae Carbapnemase Infections with Colistin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Klebsiella Pneumoniae Carbapenemase infection diagnosed by reliable culture and admitted to the infectious ward of Vali Asr Hospital are studied.
Exclusion criteria:
Allergy to fosfomycin Patients with renal failure Hemodialysis Patients Under 12 years age Patients who have received antibiotics affecting KPC for the past 72 hours.
Age
From 12 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with Random Number Table
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
Ethics committee of َArak University of Medical Sciences
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Approval date
2019-09-29, 1398/07/07
Ethics committee reference number
IR.ARAKMU.REC.1398.191

Health conditions studied

1

Description of health condition studied
Klebsiella pneumoniae Carbapnemase Infections
ICD-10 code
B96.1
ICD-10 code description
Klebsiella pneumoniae [K. pneumoniae] as the cause of diseases classified elsewhere

Primary outcomes

1

Description
Leukocytosis
Timepoint
After a week of treatment
Method of measurement
Blood cell count

2

Description
mute the fever
Timepoint
24 hours / 48 hours / 72 hours / 96 hours / over 96 hours from start of treatment
Method of measurement
Using mercury thermometer orally or axillary

3

Description
Symptoms Remedy
Timepoint
24 hours / 48 hours / 72 hours / 96 hours / over 96 hours from start of treatment
Method of measurement
Asking about the patient and the patient's status by observation

4

Description
Negative urine culture
Timepoint
After 72 hours of treatment
Method of measurement
urine culture test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first 7 days of treatment, 31 patients will receive colistin (3 million units of TDS injectable colistin) along with oral fosfomycin (3 g per 12-hour dose). The total duration of treatment is 14 days.
Category
Treatment - Drugs

2

Description
Control group: 31 patients will receive colistin for a total of 14 days (3 million units of TDS injectable colistin)
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Vali Asr hospital
Full name of responsible person
Dr hosein sarmadian
Street address
Valiasr Hospital,Shahid Shiroudi Street, Arak, Iran
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
hosseinsarmadian2015@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Research Assistant, Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr hosein sarmadian
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Infectious diseases
Street address
Valiasr Hospital,Shahid Shiroudi Street, Arak, Iran
City
arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
hosseinsarmadian2015@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr ehsanollah ghznavi rad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Microbiology
Street address
Valiasr Hospital,Shahid Shiroudi Street, Arak, Iran
City
arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
e.ghaznavirad@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
nazanin pourafshari
Position
Infectious disease Resident
Latest degree
Medical doctor
Other areas of specialty/work
Infectious diseases
Street address
Valiasr Hospital,Shahid Shiroudi Street, Arak, Iran
City
arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Fax
+98 86 3222 2003
Email
nazanin.pourafshari21@gmail.com

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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
When the article was out of print.
When the data will become available and for how long
After publishing the article
To whom data/document is available
University researchers
Under which criteria data/document could be used
If there are any further questions
From where data/document is obtainable
Dr hosein samadian
What processes are involved for a request to access data/document
Letter writing should be done with professors and universities.
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