Study of 5 and 10 days treatment with penicillin against sore throat caused by streptococci.

Phase 1

• Conditions: J03.0 Streptococcal pharyngotonsillitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-001752-30-SE
• Lead Sponsor: Public Health Agency of Sweden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-21
• Study Completion: 2018-06-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 422

Inclusion Criteria

Adults, adolescents and children = 6 years of age with verified streptococcal pharyngotonsillitis.
Are the trial subjects under 18? yes
Number of subjects for this age range: 250
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Signs of serious infection.
Known hypersensitivity against penicillin.
Chronic disease with effect on the immune response.
Immunosuppressive treatment.
Streptococcal tonsillitis within one month (relapse).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the clinical efficacy of 5 days (800 mg x 4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin in adults, adolecsents and children with streoptococcal tonsillitis.;<br> Secondary Objective: Bacteriological cure.<br> Frequency of relapse.<br> Time to relief of symptoms.<br> Frequency of purulent and non-purulent complications.<br> Ecological impact on feacal microbiota.<br> ;Primary end point(s): Clinical cure. ;Timepoint(s) of evaluation of this end point: 5-7 days after discontinuation of treatment.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): 1. Bacteriological cure.<br> 2. Frequency of relapses.<br> 3. Frequency of complications.<br> ;<br> Timepoint(s) of evaluation of this end point: 1. 5-7 Days after discontinuation of treatment.<br> 2. One month after discontinuation of treatment.<br> 3. Within 3 months after discontinuation of treatment.<br>