Evaluation of the clinical course and consequences of disease in the children suspicious to Covid-19 who have/have not received Antibiotics
Design
This is a clinical trial study with control group, double blind , randomized with software allocation random software.
Settings and conduct
70 patients with suspected Covid 19 will be selected. Patients are between 2 and 14 years old.
Then the patients are divided into two groups of 35. The first group (control) received routine treatment. Gram for each kilogram is prescribed every 8 hours for at least 7 days.
During the review of the file and the clinical course of the patients, the group started with antibiotics and the group with similar symptoms, the antibiotics were not started for the patient. In case of any evidence that children need antibiotic treatment, they will be excluded from the study.
Patients' clinical signs and inflammatory tests are recorded on the first and seventh day
Participants/Inclusion and exclusion criteria
Participants:
Patients suspected of having Covid 19 with approved molecular test admitted to Hajar Hospital in Shahrekord In the year 1400 ;
Inclusion criteria:
confirmed molecular test;
Patient with positive IgM test;
Exclusion criteria:
History of any underlying disease;
the patient needs antibiotics;
Dissatisfaction of the patient and his family;
Intervention groups
Intervention group: receiving routine treatment + antibiotic cephalosporins (cefotaxime) and injectable at a dose of 50 mg / kg every 8 hours for at least 7 days
Control group: Routine treatment (serum therapy, acetaminophen, etc.)
Main outcome variables
Age, sex, respiratory rate, inflammatory tests, duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220116053739N1
Registration date:2022-04-15, 1401/01/26
Registration timing:retrospective
Last update:2022-04-15, 1401/01/26
Update count:0
Registration date
2022-04-15, 1401/01/26
Registrant information
Name
Maryam Mohsenifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3333 5833
Email address
amin_mohsenifar@auto.iust.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-28, 1400/07/06
Expected recruitment end date
2022-01-26, 1400/11/06
Actual recruitment start date
2021-09-28, 1400/07/06
Actual recruitment end date
2022-03-30, 1401/01/10
Trial completion date
empty
Scientific title
Evaluation of the clinical course and consequences of disease in the children suspicious to Covid-19 who have/have not received Antibiotics
Public title
Evaluation of the clinical course and consequences of disease in the children suspicious to Covid-19 who have/have not received Antibiotics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient with IgM positive
The patient with confirmed molecular test
Exclusion criteria:
Having the background of Underlying disease
Any clinical or laboratory evidence of the patient need for Antibiotics
Lack of consent of the patient and his/her family for the participation in the study
Age
From 2 years old to 14 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
70
Actual sample size reached:
101
Randomization (investigator's opinion)
Randomized
Randomization description
The participants have been randomly distributed to the control and experimental groups using Random Allocation Software
Blinding (investigator's opinion)
Double blinded
Blinding description
In selecting the envelopes, neither the participant nor the researcher is not aware of the envelope content and an envelope is randomly selected for each patient. After selecting an envelope, the parents of the patient are informed if the patient had received Antibiotic or not. Even the researcher was not informed of that.
The number of participants in the study was considered to be envelopes with numbers 1 to 70 and using the software, the number 0 or 1 was randomly assigned to each envelope, and the number zero means not receiving antibiotics and the number 1 It means taking antibiotics
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
somaheh Blvd.
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814873588
Approval date
2021-09-28, 1400/07/06
Ethics committee reference number
IR.SKUMS.REC.1400.145
Health conditions studied
1
Description of health condition studied
Covid-19
ICD-10 code
U07.1
ICD-10 code description
Covid 19
Primary outcomes
1
Description
Duration of hospitalization
Timepoint
Time of discharge from the hospital
Method of measurement
Number of days hospitalized
2
Description
Complete blood count (CBC)
Timepoint
Day of hospitalization, seven days after hospitalization
Method of measurement
Use of cell counting machine
3
Description
Fever
Timepoint
Day of hospitalization, seven days after hospitalization and One month after hospitalization
Method of measurement
Thermometer
4
Description
Cough
Timepoint
Day of hospitalization, seven days after hospitalization and One month after hospitalization
Method of measurement
Asking the patient
Secondary outcomes
1
Description
Test result of Troponin
Timepoint
Day of hospitalization and seven days after hospitalization
Method of measurement
Troponin test kit
2
Description
D-dimer
Timepoint
Day of hospitalization and seven days after hospitalization
Method of measurement
Latex agglutination test
3
Description
Erythrocyte Sedimentation Rate (ESR)
Timepoint
Day of hospitalization and seven days after hospitalization
Method of measurement
The Westergren method
4
Description
C-reactive protein test (CRP)
Timepoint
Day of hospitalization and seven days after hospitalization
Method of measurement
Latex agglutination test
5
Description
Anorexia
Timepoint
Day of hospitalization, seven days after hospitalization and One month after hospitalization
Method of measurement
Asking the patient
Intervention groups
1
Description
Patients in the intervention group were treated with a group of antibiotics with gram-negative and gram-positive coverage (third generation cephalosporin). Third-generation cephalosporins include cefotaxime (from Eixir Pharmaceutical Company) as an injection at a dose of 50 mg per kg every 8 hours for at least 7 days. Also in this group, the routine hospital care intervention intended for the control group included serum therapy (including normal saline serum, one-third and two-thirds serum), and the use of antipyretics (acetaminophen at a dose of 10 mg per kg). It was administered orally or by injection in patients with a body temperature of more than 38 with an interval of at least 6 hours.
Category
Treatment - Drugs
2
Description
In the control group, patients did not receive any antibiotics and routine hospital care included serum therapy (including normal saline, one-third and two-thirds serum), and the use of antipyretics (acetaminophen at a dose of 10 mg per kg). Received orally or by injection in patients with a body temperature greater than 38 (at least 6 hours apart) during hospitalization.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hajar hospital of Shahrekord
Full name of responsible person
Maryam Mohsenifar
Street address
parastar street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814873588
Phone
+98 38 3222 0016
Email
info@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Mehraban Sadeghi
Street address
Kashani Blvd., the headquarters of Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
vcrt@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahrekord University Medical Science
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Maryam Mohsenifar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Somaheh Blvd.
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814873588
Phone
0983833335833
Email
amin_mohsenifar@outlook.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Nabiollah Asadpour
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Parastar Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
n.asadpour@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Maryam Mohsenifar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Somaheh Street
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814873588
Phone
+98 38 3333 5833
Email
amin_mohsenifar@outlook.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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