Once-daily Therapy for Streptococcal Pharyngitis - Full Text View

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 Blind (Subject) Primary Purpose: Treatment
Official Title:	Once-daily Therapy for Streptococcal Pharyngitis

Resource links provided by NLM:

MedlinePlus related topics: Sore Throat

Drug Information available for: Penicillin G procaine Penicillin G Penicillin G sodium Penicillin G potassium Bicillin C-R Amoxicillin Amoxicillin sodium Penicillin G benzathine

U.S. FDA Resources

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)

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

Ages Eligible for Study:	6 Years to 15 Years
Genders Eligible for Study:	Both

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received:	March 7, 2011
Last Updated:	March 7, 2011
Health Authority:	Iran : Islamic azad university

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

Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013