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

A randomised study of 5 and 10 days treatment with phenoxymethyl penicillin against streptococcal pharyngotonsillitis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001752-30-SE

Enrollment

432

Registered

2015-05-21

Start date

2015-07-03

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

J03.0 Streptococcal pharyngotonsillitis

Interventions

Trade Name: Kåvepenin/Fenoximetylpenicillin Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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).

Design outcomes

Primary

Measure	Time frame
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.; Secondary Objective: Bacteriological cure. Frequency of relapse. Time to relief of symptoms. Frequency of purulent and non-purulent complications. Ecological impact on feacal microbiota. ;Primary end point(s): Clinical cure. ;Timepoint(s) of evaluation of this end point: 5-7 days after discontinuation of treatment.	—

Measure

Time frame

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.; Secondary Objective: Bacteriological cure. Frequency of relapse. Time to relief of symptoms. Frequency of purulent and non-purulent complications. Ecological impact on feacal microbiota. ;Primary end point(s): Clinical cure. ;Timepoint(s) of evaluation of this end point: 5-7 days after discontinuation of treatment.

—

Secondary

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

Countries

Sweden

Contacts

Public ContactAntibiotics and Infection Control

Public Health Agency of Sweden

46102052000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 20, 2026