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Once-daily Therapy for Streptococcal Pharyngitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01310361
First Posted: March 8, 2011
Last Update Posted: March 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Azad University of Medical Sciences
  Purpose
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.

Condition Intervention Phase
Streptococcal Sore Throat Drug: Amoxicillin Drug: Intramuscular Benzathin Penicillin G Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Once-daily Therapy for Streptococcal Pharyngitis

Resource links provided by NLM:


Further study details as provided by Azad University of Medical Sciences:

Study Start Date: January 2004
Estimated Study Completion Date: March 2006
Arms Assigned Interventions
Experimental: Amoxicillin
Once-daily Therapy for Streptococcal Pharyngitis With Amoxicillin
Drug: Amoxicillin
Active Comparator: Benzathin Penicillin G
Once-daily Therapy for Streptococcal Pharyngitis With Intramuscular Benzathin Penicillin G
Drug: 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)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

Inclusion Criteria:

  1. Age of 6 to 15 years old.
  2. 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.
  3. No antibiotic was used during the week before.
  4. -Performing throat culture before the initiation of drug administration
  5. Positive throat culture indication GABHS
  6. No previous history of allergy to penicillin .

Exclusion Criteria:

  1. Age of below 6 years old or above 15 years old.
  2. No signs of pharyngitis in the clinical examination
  3. Antibiotic use during the week before.
  4. Throat culture was not performed before the initiation of drug administration.
  5. Negative throat culture or the culture indicates a microorganism other than GABHS.
  6. History of allergy to penicillin
  7. Not using drugs or not following the treatment in the field of having the second culture performed.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01310361


Locations
Iran, Islamic Republic of
Islamic Azad University
Mashhad, Khorasan, Iran, Islamic Republic of, 91796
Sponsors and Collaborators
Azad University of Medical Sciences
  More Information

Responsible Party: Reasercheal Deputy of Islamic Azad University ,Mashhad Branch,Mashhad,Iran., Islamic Azad University ,Mashhad Branch,Mashhad,Iran.
ClinicalTrials.gov Identifier: NCT01310361     History of Changes
Other Study ID Numbers: iaum
First Submitted: March 7, 2011
First Posted: March 8, 2011
Last Update Posted: March 8, 2011
Last Verified: January 2005

Keywords provided by Azad University of Medical Sciences:
Pharyngitis
Group A β-hemolytic Streptococci
Exudate
Erythema Penicillin
Amoxicillin

Additional relevant MeSH terms:
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Amoxicillin
Penicillins
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Anti-Bacterial Agents
Anti-Infective Agents