Protocol summary

Summary
This controlled, randomized, single-blind study included patients diagnosed clinically with ocular toxoplasmosis, as defined by the presence of visual complaints and an area of focal necrotizing retinochoroidal lesion appearing as a whitish yellow region with a blurred margin plus or minus the accompaniment of an old lesion. Patients were recruited from the Nikookari Hospital Uveitis Clinic, Tabriz, Iran. Patients consented to participation in the study, and it was approved by the ethics committees of the hospital and the Tabriz University of Medical Sciences. Of the 72 patients enrolled in the study, all completed follow-up. 36 patients were treated with the classic regimen consisting of Pyrimethamine and Sulfadiazine, and 36 were treated with Azithromycin. An initial loading dose of 100 mg of Pyrimethamine , followed by a 50-mg dose daily, and sulfadiazine with loading dose of 2 gr followed by 500-mg dosing every 6 hours, and 5 mg of Folinic acid daily as the classic treatment protocol was used. In the other group, 1 tablets of Azithromycin 250 mg daily was used . In both groups, drugs were continued for 6 weeks; oral Prednisolone was administered at 1 mg/kg daily starting from the third day of therapy, and the dose was tapered over 2 weeks. Response to treatment was identified as sharpening of the lesion border with or without hyperpigmentation and resolution of vitreous inflammation

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201702146568N2
Registration date: 2017-03-01, 1395/12/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-01, 1395/12/11
Registrant information
Name
Leila Alizadeh ghavidel
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1655 1332
Email address
alizadehl@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2017-02-26, 1395/12/08
Expected recruitment end date
2019-02-21, 1397/12/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Azithromycin and Pyrimethamine/sulfadiazine Treatment in Ocular Toxoplasmosis
Public title
Comparison of Azithromycin and Pyrimethamine/sulfadiazine Treatment in Ocular Toxoplasmosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Presence of the retinal lesion at least 500 micrometers outside the center of the macula. 2. Lack of history of allergic reaction to the drugs used in this study. 3. Lack of any other ocular disease. Exclusion criteria: 1. Visual acuity (VA) of lesser than 20/200 2. Location of the lesion within the center (500 micrometers) of the macula 3. Development of an allergic reaction to the medication 4. Leukopenia (white blood cell count lesser than 5000) or platelet count lesser than120 000/ml
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2017-02-09, 1395/11/21
Ethics committee reference number
IR.TBZMED.REC.1395.1173

Health conditions studied

1

Description of health condition studied
Retinochoroiditis
ICD-10 code
B58.0
ICD-10 code description
Toxoplasma Oculopathy

Primary outcomes

1

Description
The clinical improvement
Timepoint
One week, one month and three months after the first dose
Method of measurement
Ophthalmoscope

Secondary outcomes

1

Description
Visual acuity
Timepoint
One week, one month and three months after treatment.
Method of measurement
Using the Snellen chart

2

Description
The recurrence rate
Timepoint
هر 6 ماه تا 2 سال
Method of measurement
Ophthalmoscope

Intervention groups

1

Description
Group A: azithromycin 500 mg on the first day and then 250 mg daily
Category
Treatment - Drugs

2

Description
Group B: pyrimethamine 100 mg the first day and 50 mg sulfadiazine 500 mg every 6 hours for 2 days then 1 mg a day among a number folinic acid
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinics of Nikukari hospital
Full name of responsible person
Leila Alizadeh ghavidel
Street address
Nikukari hospital, Abbasi street
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
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,Tabriz 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
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Leila Alizadeh ghavidel
Position
Assistant Professor of Immunology eyes
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Leila Alizadeh ghavidel
Position
Assistant Professor of Immunology eyes
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Leila Alizadeh ghavidel
Position
Assistant Professor of Immunology eyes
Other areas of specialty/work
Street address
Nikukari hospital, Abbasi street
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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