Once-daily Therapy for Streptococcal Pharyngitis

Streptococcal Sore Throat Clinical Trial

Official title:

Once-daily Therapy for Streptococcal Pharyngitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310361
• Other study ID #: iaum
• Status: Completed
• Phase: Phase 1
• First received: March 7, 2011
• Last updated: March 7, 2011
• Start date: January 2004
• Est. completion date: March 2006

Study information

• Verified date: January 2005
• Source: Azad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran : Islamic azad university
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2006
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pharyngitis
• Streptococcal Sore Throat

Intervention

Drug:
• Amoxicillin

• 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)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Islamic Azad University	Mashhad	Khorasan

Sponsors (1)

Lead Sponsor	Collaborator
Azad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of,