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Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci

A

Ass. Prof. Katarina Hedin

Status and phase

Completed
Phase 4

Conditions

Tonsillitis

Treatments

Drug: Phenoxymethylpenicillin

Study type

Interventional

Funder types

Other

Identifiers

NCT02712307
2015-001752-30 (EudraCT Number)
FoHM/Tonsillit2015

Details and patient eligibility

About

The primary objective of the study is to compare the clinical efficacy of 5 days (800 mg x 4) versus 10 days (1000 mg x 3) treatment with phenoxymethylpenicillin (PcV) in adults, adolescents and children with streptococcal tonsillitis. Patients are recruited from 17 primary Health care centres in the south of Sweden. Adult men and women, youth and children ≥ 6 years of age who are visiting the primary Health care for sore throat with suspected tonsillitis and meeting the criteria in accordance with current treatment recommendations for pharyngotonsillitis, ie 3-4 Centor criteria (fever≥ 38.5, tender lymph nodes, coatings of the tonsils and absence of cough) and a positive rapid antigen detection test (RADT) for Group A streptococcus (GAS) will be included in the study. Patients will be randomized to be prescribed PcV of 5 and 10 days. Each patient or guardian fills daily in a short diary including aches, fever, PcV doses, pain relievers, adverse events etc. Five to seven days after last intake of PcV the general practioner make a clinical judgement if the patient has recovered from the pharyngotonsillitis. Questions to be asked are if remaining symptoms or new symptoms of sore throat is present, if adverse events have been noted or of any extra physician visits have been made. Throat swab for semi quantitative cultures of Streptococcus group A, C and G are made at randomization and five to seven days after last intake of PcV. A study nurse will contact the patients one month and three months after the last treatment day for follow-up. If the patient has reconsulted or been hospitalised for a sore throat or possible complication, those patient records will be examined.

Enrollment

433 patients

Sex

All

Ages

6+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adults, adolescents and children ≥ 6 years of age with verified streptococcal pharyngotonsillitis.

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

433 participants in 2 patient groups

5 days
Experimental group
Description:
Phenoxymethylpenicillin 800 mg x 4 for 5 days
Treatment:
Drug: Phenoxymethylpenicillin
10 days
Active Comparator group
Description:
Phenoxymethylpenicillin 1000 mg x 3 for 10 days
Treatment:
Drug: Phenoxymethylpenicillin

Trial contacts and locations

17

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Data sourced from clinicaltrials.gov

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