Determination of the effect of oral clarithromycin on acute cutaneous leishmaniasis lesions in comparison with systemic glucantime
Design
Patients are divided into intervention and control groups using simple randomization method. Based on first phase of trial, sample size in each group is 20 people. No blinding will be done in this study.
Settings and conduct
This study will be carried out on 20 patients with acute cutaneous leishmaniasis referring to Qaem Hospital and no blinding is done in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Having an indication of systemic therapy, less than 12 weeks of illness, no previous treatment
Exclusion criteria:Pregnancy, breastfeeding, use of other treatment methods during the course of treatment, previous history of local or systemic diseases within less than two months, history of intolerance or allergies tomacrolide, severe underlying diseases, such as heart, kidney and liver diseases
Intervention groups
Intervention group: Qualified patients are treated with oral clarithromycin with 500 mg dosage twice a day for 2 months.
Control group: Patients are treated with systemic glucantime with 20 mg/kg dosage for 20 days up to 3 ampoules per day.
Main outcome variables
percentage of complete improvement, size changes, changes in firmness of the lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180411039265N1
Registration date:2018-05-05, 1397/02/15
Registration timing:registered_while_recruiting
Last update:2018-05-05, 1397/02/15
Update count:0
Registration date
2018-05-05, 1397/02/15
Registrant information
Name
Naghmeh Zabolinejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3858 3845
Email address
zabolinejadng@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-02, 1395/08/12
Expected recruitment end date
2018-08-21, 1397/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of oral clarithromycin with systemic glucantime on the treatment of acute cutaneous leishmaniasis
Public title
Comparison of the effect of oral clarithromycin with systemic glucantime on the treatment of acute cutaneous leishmaniasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having an indication of systemic treatment in patients with acute cutaneous leishmaniasis
less than 12 weeks of illness
receiving no previous treatment
Exclusion criteria:
Pregnancy
Breastfeeding
Use of other methods of treatment during the course of treatment
Past medical history of any local or systemic disease during the last 2 months
History of intolerance or allergies to macrolides
A significant underlying disease such as heart, renal, or liver diseases.
Use of other treatments before referral
Age
From 16 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method is used to divide the patients into intervention and control groups.
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2016-10-05, 1395/07/14
Ethics committee reference number
IR.MUMS.fm.REC.1395.289
Health conditions studied
1
Description of health condition studied
Cutaneous Leishmaniasis
ICD-10 code
B55.1
ICD-10 code description
Cutaneous leishmaniasis
Primary outcomes
1
Description
Percentage of complete recovery of the lesion
Timepoint
Follow-up and assessment of recovery are done every two weeks, and the duration of the therapeutic effect of the lesions is assessed based on changes in the size, extent, redness and firmness of the lesions. The treatment period is considered two month. Patients will also be followed 6 weeks, 3 months and 6 months after the treatment is over
Method of measurement
Measuring size of the lesion with digital caliper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: reception of oral Clarithromycin with 500 mg dosage twice a day for two months
Category
Treatment - Drugs
2
Description
Control group: treatment with systemic glucantime with 20 mg/kg dosage per day for 20 days up to 3 ampules daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital
Full name of responsible person
Naghmeh Zabolinejad
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2040
Email
zabolinejadng@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3841 1538
Email
ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Somaye Ghanizadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 5733
Email
somayeghanizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naghmeh Zabolinejad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 5733
Email
zabolinejadng@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naghmeh Zabolinejad
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Emam Reza Sq, Ebne-sina Ave, Emam Reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 5733
Email
zabolinejadng@mums.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
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
All data can be shared after patients are made unidentifiable
When the data will become available and for how long
Data can be accessible 6 months after results are published
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes
Under which criteria data/document could be used
Carrying out analysis on data is permitted
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.