Back to resultsOnce-daily Therapy for Streptococcal Pharyngitis
Primary Purpose
Streptococcal Sore Throat
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Amoxicillin
Intramuscular Benzathin Penicillin G
Sponsored by
About this trial
This is an interventional treatment trial for Streptococcal Sore Throat focused on measuring Pharyngitis, Group A β-hemolytic Streptococci, Exudate, Erythema Penicillin, Amoxicillin
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
- Age of 6 to 15 years old.
- The criteria in clinical examination including objective signs (fever, Erythema or exudate of tonsils, enlarged lymph nodes) and subjective sign(sore throat). Neck tenderness, abdominal pain and pharynx petechia were also considered.
- No antibiotic was used during the week before.
- -Performing throat culture before the initiation of drug administration
- Positive throat culture indication GABHS
- No previous history of allergy to penicillin .
Exclusion Criteria:
- Age of below 6 years old or above 15 years old.
- No signs of pharyngitis in the clinical examination
- Antibiotic use during the week before.
- Throat culture was not performed before the initiation of drug administration.
- Negative throat culture or the culture indicates a microorganism other than GABHS.
- History of allergy to penicillin
- Not using drugs or not following the treatment in the field of having the second culture performed.
Sites / Locations
- Islamic Azad University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Amoxicillin
Benzathin Penicillin G
Arm Description
Once-daily Therapy for Streptococcal Pharyngitis With Amoxicillin
Once-daily Therapy for Streptococcal Pharyngitis With Intramuscular Benzathin Penicillin G
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01310361
First Posted
March 7, 2011
Last Updated
March 7, 2011
Sponsor
Azad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01310361
Brief Title
Once-daily Therapy for Streptococcal Pharyngitis
Official Title
Once-daily Therapy for Streptococcal Pharyngitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2005
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Azad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
In some studies once daily amoxicillin therapy might be treatment of choice for Group A β-hemolytic Streptococcus pharyngitis in comparison with three to four times daily treatment with oral penicillin V.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Streptococcal Sore Throat
Keywords
Pharyngitis, Group A β-hemolytic Streptococci, Exudate, Erythema Penicillin, Amoxicillin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Arm Title
Amoxicillin
Arm Type
Experimental
Arm Description
Once-daily Therapy for Streptococcal Pharyngitis With Amoxicillin
Arm Title
Benzathin Penicillin G
Arm Type
Active Comparator
Arm Description
Once-daily Therapy for Streptococcal Pharyngitis With Intramuscular Benzathin Penicillin G
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Type
Drug
Intervention Name(s)
Intramuscular Benzathin Penicillin G
Intervention Description
It is mentioned underlined in page 10 in research. (Once the throat swab was taken and cultured on plate at the place where the child was examined, hygiene teacher was trained about how to prepare the oral amoxicillin suspension and how to give it to the child. 750 milligrams of amoxicillin was thereafter given to the patient and in order not to infect other school children, the patient was sent home. The following morning, the patient would come to school and was given the second dose of amoxicillin by the hygiene teacher. All oral drugs were bought from a creditable company. In the injection group, 600000 units of penicillin was administered to children who weigh less than 27 kilograms and 1200000 units of penicillin was administered to children who weigh more. After 48 hours, patients were examined again when the result of first culture was ready)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Eligibility Criteria
Inclusion Criteria:
Inclusion Criteria:
Age of 6 to 15 years old.
The criteria in clinical examination including objective signs (fever, Erythema or exudate of tonsils, enlarged lymph nodes) and subjective sign(sore throat). Neck tenderness, abdominal pain and pharynx petechia were also considered.
No antibiotic was used during the week before.
-Performing throat culture before the initiation of drug administration
Positive throat culture indication GABHS
No previous history of allergy to penicillin .
Exclusion Criteria:
Age of below 6 years old or above 15 years old.
No signs of pharyngitis in the clinical examination
Antibiotic use during the week before.
Throat culture was not performed before the initiation of drug administration.
Negative throat culture or the culture indicates a microorganism other than GABHS.
History of allergy to penicillin
Not using drugs or not following the treatment in the field of having the second culture performed.
Facility Information:
Facility Name
Islamic Azad University
City
Mashhad
State/Province
Khorasan
ZIP/Postal Code
91796
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Once-daily Therapy for Streptococcal Pharyngitis
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