Protocol summary

Study aim
Determination and comparison of the effect of short-term treatment with Levofloxacin and Azithromycin in bronchiectasis patients in the prevention of respiratory tract infections
Design
This is a randomized, double-blind, parallel-based and community-based clinical trial study conducted in Phase 3 on 82 patients with bronchiectasis diagnosis. Patients randomly divided into two groups receiving Azithromycin or Levofloxacin on basis of random numbers.
Settings and conduct
After approving the research proposal from medical school, the researcher will enter the patients who have criteria for entering the study after explaining the goals and conditions of the study and obtaining informed consent. In one group, Levofloxacin will receive 5 days a month, and in another group, patients will receive Azithromycin at a dose of 250 mg per day throughout the duration of study. Medications will be identified with codes A and B and will be in the same shape, and therefore the patient and assessing person (physician) will not know how patients allocated.
Participants/Inclusion and exclusion criteria
All patients with generalized bronchiectasis accompanied by septic mucus that have exacerbated disease more than 3 times in year Entry criteria: having a definite diagnosis of bronchiectasis, satisfaction to participate in study Exit criteria: having CF, allergies, asthma, tuberculosis
Intervention groups
Patients will be randomly divided into two equal groups after entering the study. In one group, Levofloxacin 500 mg will receive 5 days in month, and in another group, patients will receive Azithromycin 250 mg per day throughout the duration of study. Patients have been followed for one year and during this time, the number of admissions and number of exacerbations will be compared.
Main outcome variables
Average frequency of exacerbations of bronchiectasis, average admission rate, frequency of side effects

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190109042312N1
Registration date: 2019-02-19, 1397/11/30
Registration timing: registered_while_recruiting

Last update: 2019-02-19, 1397/11/30
Update count: 0
Registration date
2019-02-19, 1397/11/30
Registrant information
Name
Farzane Peykfalak
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5789
Email address
farzane_p471@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The preventive effects of short-course treatment with Levofloxacin in comparison with Azithromycin in bronchiectasis patients
Public title
Effect of Levofloxacin and Azithromycin in bronchiectasis patients treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a definitive diagnosis of bronchiectasis Satisfaction to participate in the study
Exclusion criteria:
Having cystic fibrosis, allergies, asthma, tuberculosis
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 82
Randomization (investigator's opinion)
Randomized
Randomization description
Patients randomly divided into two groups receiving Azithromycin or Levofloxacin on the basis of random numbers. Medications will be marked with codes A and B and will be in the same shape.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications will be identified with codes A and B and will be in the same shape, and therefore the patient and the assessing person (physician) will not know how patients allocated.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Scienses, Dr Hesabi sq., Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.ZAUMS.REC.1397.429

Health conditions studied

1

Description of health condition studied
Bronchiectasis
ICD-10 code
J47
ICD-10 code description
Bronchiectasis

Primary outcomes

1

Description
exacerbation
Timepoint
During and after the end of the data collection
Method of measurement
By the form of information

Secondary outcomes

1

Description
Number of admissions
Timepoint
During and after the end of the data collection
Method of measurement
By the form of information

Intervention groups

1

Description
Intervention group: Levofloxacin - In this group, patients will receive Levofloxacin for 5 days with the dose of 500mg in a month and will be followed for one year, during that time the number of admissions and the number of exacerbations will be examined and compared.
Category
Treatment - Drugs

2

Description
Intervention group: Azithromycin - In this group, patients will receive Azithromycin at a dose of 250 mg per day throughout the study period and will be followed for one year, during that time the number of admissions and the number of exacerbations will be examined and compared.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali ibn Abitaleb Hospital of Zahedan
Full name of responsible person
Dr Kazem Momeni
Street address
Khalije Fars highway, Salamat blvd., Ali ibn Abitaleb Hospital of Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
drkazemmomeni@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Mohsen Taheri
Street address
Zahedan University of Medical Scienses, Dr Hesabi sq., Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5796
Email
taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Farzane Peykfalak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Zahedan University of Medical Scienses, Dr Hesabi sq., Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5789
Email
farzane_p471@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farzane Peykfalak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Zahedan University of Medical Scienses, Dr Hesabi sq., Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5789
Email
farzane_p471@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farzane Peykfalak
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Zahedan University of Medical Scienses, Dr Hesabi sq., Zahedan, Iran
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5789
Email
farzane_p471@zaums.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
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
Title and more details about the data/document
Only part of the data, such as information on the main outcome, can be shared.
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will only be available to academic researchers
Under which criteria data/document could be used
It is only allowed to use the data to give ideas for future research
From where data/document is obtainable
Access to the documentation will be possible through the University's Research deputy
What processes are involved for a request to access data/document
Access to the documentation will be possible by following the relevant routine
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