General Objective: To determine the prevalence of streptococcal resistance in children with streptococcal pharyngitis
Design
Clinical trial with parallel, non-random, phase 2 groups on 310 patients
Settings and conduct
In this study, 310 children with symptoms of pharyngitis were studied.
After receiving the result of pharyngeal 24-hour culture, patients who had a positive culture, ie Streptococcus pharyngitis group A was confirmed, were treated with antibiotics and were included in the study.
All positive cultures were evaluated for antibiotic resistance to azithromycin, penicillin, clindamycin, and amoxicillin (antibiogram review).
Participants/Inclusion and exclusion criteria
inclusion criteria:
1- No history of tonsillectomy
2- Do not take antibiotics in the last two weeks
3- No complaints and symptoms of upper respiratory infection (cough, sneezing and runny nose)
4- Justification of the patient or his family and patients' desire to participate in the study.
exclusion criteria:
Patients under 3 years of age or over 15 years of age are not included in the study.
Intervention groups
Intervention group 1 includes patients receiving penicillin antibiotic and then pharyngeal culture to evaluate resistance.
Intervention group 2 includes patients receiving azithromycin antibiotic and then pharyngeal culture to evaluate resistance.
Intervention group 3 includes patients receiving clindamycin antibiotic and then pharyngeal culture to evaluate resistance.
Intervention group 4 includes patients receiving amoxicillin antibiotic and then pharyngeal culture to evaluate resistance.
Main outcome variables
Determination of antibiotic resistance to the studied antibiotics and better treatment choice
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200720048140N1
Registration date:2020-07-27, 1399/05/06
Registration timing:retrospective
Last update:2020-07-27, 1399/05/06
Update count:0
Registration date
2020-07-27, 1399/05/06
Registrant information
Name
Maryam Shammaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3230 3245
Email address
mary.zavare@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2019-03-20, 1397/12/29
Trial completion date
2019-03-20, 1397/12/29
Scientific title
The prevalence of antibiotic resistance in pediatrices (3-15 years old) with streptococcal pharyngitis
Public title
The prevalence of antibiotic resistance in pediatrices (3-15 years old) with purulent sore throat
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- No history of tonsillectomy
No antibiotics in the last two weeks
Absence of complaints and symptoms of upper respiratory infection (cough, sneezing and runny nose)
Justification of the patient or his family and patients' desire to participate in the study
Exclusion criteria:
Age under 3 or over 15 years
Age
From 3 years old to 15 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
310
Actual sample size reached:
310
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 Kashan University of Medical Sciences
Street address
Qutb Ravandi Boulevard
City
kashan
Province
Isfehan
Postal code
87159-81151
Approval date
2018-05-21, 1397/02/31
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.004
Health conditions studied
1
Description of health condition studied
Streptococcal pharyngitis
ICD-10 code
J02.0
ICD-10 code description
Streptococcal pharyngitis
Primary outcomes
1
Description
Throat culture
Timepoint
Throat culture at the beginning of the study and After prescribing antibiotics
Method of measurement
Swap and culture dish
Secondary outcomes
1
Description
Antibiogram
Timepoint
After administration of antibiotics in positive culture cases
Method of measurement
Antibiotic disc
Intervention groups
1
Description
Patients with positive culture, ie definite cases of streptococcal pharyngitis; Divided into 4 groups Intervention group 1: (Penicillin group) In this group of patients weighing less than 27 kg one dose of penicillin 6.3.3 muscle ampoule and Patients weighing more than 27 kg one dose of penicillin muscle ampoule 1.2 million units and 48 hours later re-culture and antibiogram were performed to evaluate antibiotic resistance.(Tri-Pen vial 6.3.3 and Benzapen vial 1,200,000 units)
Category
Treatment - Drugs
2
Description
Intervention group2 : azithromycin group In this group, patients treated with suspension or azithromycin tablets with a dose of 12 mg per kg, single daily dose for 5 days.Then re-culture and antibiogram were performed to evaluate antibiotic resistance.(Azithromycin suspension 100 and 200 mg and tablets 250 and 500 mg from Farabi company)
Category
Treatment - Drugs
3
Description
Intervention group3: clindamycin group In this group, patients were treated with clindamycin at a dose of 7 mg per kg per dose, every 8 hours, for 10 days.Then re-culture and antibiogram were performed to evaluate antibiotic resistance.(Clindafarm capsules 150 and 300 mg)
Category
Treatment - Drugs
4
Description
Intervention group4: amoxicilin group In this group, patients were treated with amoxicillin at a dose of 50 mg per kg daily, divided every 8 hours, for 10 days.Then re-culture and antibiogram were performed to evaluate antibiotic resistance.(Amoxicillin suspension 125 and 250 mg and capsules 250 and 500 mg from Farabi company)