- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01310361
Once-daily Therapy for Streptococcal Pharyngitis
March 7, 2011 updated by: Azad University of Medical Sciences
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Khorasan
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Mashhad, Khorasan, Iran, Islamic Republic of, 91796
- Islamic Azad University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 15 years (Child)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Amoxicillin
Once-daily Therapy for Streptococcal Pharyngitis With Amoxicillin
|
|
|
Active Comparator: Benzathin Penicillin G
Once-daily Therapy for Streptococcal Pharyngitis With Intramuscular Benzathin Penicillin G
|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Study Completion
March 1, 2006
Study Registration Dates
First Submitted
March 7, 2011
First Submitted That Met QC Criteria
March 7, 2011
First Posted (Estimate)
March 8, 2011
Study Record Updates
Last Update Posted (Estimate)
March 8, 2011
Last Update Submitted That Met QC Criteria
March 7, 2011
Last Verified
January 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- iaum (Registry Identifier: iaum)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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