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NCT Number: NCT02712307

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

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.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alvesta vårdcentral, Alvesta, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Phenoxymethylpenicillin

Drug

Other names: Penicillin V

Primary outcomes

  1. Clinical cure

    Time frame: 5-7 days after discontinuation of treatment

    Difference between treatment groups in the rate of clinical cure. Clinical cure is defined as clinical judgement by physician and absence of Centor criteria (coating, fever and swollen Large Granular Lymphocyte glands).

Secondary outcomes

  1. Bacteriological cure

    Time frame: 5-7 days after discontinuation of treatment

    Difference between treatment groups in the rate of bacteriological cure, defined as absence of GAS in culture.

  2. Frequency of relapses

    Time frame: 1 month after discontinuation of treatment

  3. Frequency of complications

    Time frame: Within 3 months after discontinuation of treatment

Sponsors and collaborators

Lead sponsor

Ass. Prof. Katarina Hedin

Other Gov

Registry information

Official study title

A Randomized Controlled Study of 5 and 10 Days Treatment With Phenoxymethylpenicillin for Pharyngotonsillitis Caused by Streptococcus Group A

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2016
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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