This study is aimed to evaluate the efficacy of spiramycin in prevention of toxoplasma gondii transmission from mother with acute toxoplasmosis.
Design
This study will be a single arm clinical trial and recruit 50 individuals in 10 years. With respect to the nature of the study no randomization will be performed.
Settings and conduct
This clinical study will be performed in teaching hospitals of Babol University of Medical Sciences. All pregnant women with acute toxoplasmosis will be included in this study and treated with drugs until delivery, thereafter, their offspring will be followed for a year. With respect to the nature of the study no blinding or randomization will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria includes, informed consent and having positive or borderline IgM and positive IgG antibodies against Toxoplasma gondii.
Exclusion criteria includes, having high avidity test, negative IgM antibodies against Toxoplasma gondii or positive fetal anomaly screening tests.
Intervention groups
Pregnant women with acute toxoplasmosis infection will receive 1gr of spiramycin every 8 hours until delivery.
Main outcome variables
Prevalence of Toxoplasma gondii infection in children delivered from mothers with acute toxoplasmosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170201032346N5
Registration date:2020-12-26, 1399/10/06
Registration timing:retrospective
Last update:2020-12-26, 1399/10/06
Update count:0
Registration date
2020-12-26, 1399/10/06
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 91155226108
Email address
firoozihosein@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2007-09-23, 1386/07/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
2007-09-23, 1386/07/01
Actual recruitment end date
2016-09-22, 1395/07/01
Trial completion date
2018-07-23, 1397/05/01
Scientific title
The effect of spiramycin in prevention of toxoplasma gondii infection from mothers with acute toxoplasmosis
Public title
The effect of spiramycin in prevention of toxoplasma infection in neonates
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive Anti-Toxoplasma gondii IgG and IgM antibodies
Signed informed consent
Exclusion criteria:
High positive avidity test
Negative Anti-Toxoplasma gondii IgM antibodies
Positive screening tests for fetal anomalies
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
56
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vice Chancellor of Research, Moalem st, Moalem sq, Sari, Mazandaran, Iran.
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2020-11-25, 1399/09/05
Ethics committee reference number
IR.MAZUMS.REC.1395.2690
Health conditions studied
1
Description of health condition studied
Congenital Toxoplasmosis
ICD-10 code
P37.1
ICD-10 code description
Congenital toxoplasmosis
Primary outcomes
1
Description
Prevalence of congenital toxoplasmosis
Timepoint
Evaluation of infant until a year after birth
Method of measurement
Physical examination and performing diagnostic tests based on patient complaint
2
Description
Fetal abortion
Timepoint
from diagnosis and initiation of treatment until delivery
Method of measurement
History, physical examination and sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mothers will be treated with 1gr of spiramycin every 8 hours until delivery and their offspring will be followed for a year.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Yahyanezad Hospital
Full name of responsible person
Hossein Firoozi
Street address
Shahid Mostafa Khomeini St.
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3222 3594
Email
firoozihosein@mazums.ac.ir
2
Recruitment center
Name of recruitment center
Babol 17 Shahrivar Hospital
Full name of responsible person
Hossein Firoozi
Street address
Marzikola
City
Babol
Province
Mazandaran
Postal code
4716681451
Phone
+98 11 3263 7400
Email
firoozihosein@mazums.ac.ir
3
Recruitment center
Name of recruitment center
Babol Ayatollah Rouhani Hospital
Full name of responsible person
Hossein Firoozi
Street address
Ganj Afrooz St.
City
Babol
Province
Mazandaran
Postal code
47117647745
Phone
+98 11 3223 8301
Email
firoozihosein@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ramsar Campus, Mazandaran University of Medical Sciences
Full name of responsible person
Davood Farzin
Street address
No.20 ,Taleghani Ave., Ramsar.
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Phone
+98 11 5522 6108
Email
firoozihosein@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ramsar Campus, Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Firouzi Hossein
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No.20 ,Taleghani Ave., Ramsar.
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Phone
+1 155230181
Fax
Email
firoozihosein@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Firouzi Hossein
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No.20 ,Taleghani Ave., Ramsar.
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Phone
+1 155230181
Fax
Email
firoozihosein@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Firouzi Hossein
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
No.20 ,Taleghani Ave., Ramsar.
City
Ramsar
Province
Mazandaran
Postal code
4691786953
Phone
+1 155230181
Fax
Email
firoozihosein@mazums.ac.ir
Web page address
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 collected deidentified data for primary and secondary outcome measures are going to be shared.
When the data will become available and for how long
After publishing the study, data are going to be available
To whom data/document is available
data are going to be available to all researchers and clinician irrespective to their employment sector
Under which criteria data/document could be used
permission are granted upon request for secondary and meta-analysis
From where data/document is obtainable
requests are gathered through principle researcher's e-mail address
What processes are involved for a request to access data/document
requests are gathered through principle researcher's e-mail address