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

Tonsillitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712307
• Other study ID #: FoHM/Tonsillit2015
• Secondary ID: 2015-001752-30
• Status: Completed
• Phase: Phase 4
• Start date: September 2015
• Est. completion date: June 2018

Study information

• Verified date: November 2018
• Source: Public Health Agency of Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: June 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Tonsillitis

Intervention

Drug:
• Phenoxymethylpenicillin

Locations

Country	Name	City	State
Sweden	Alvesta vårdcentral	Alvesta
Sweden	Närhälsan Bollebygd vårdcentral	Bollebygd
Sweden	Capio Citykliniken Bunkeflo Hyllie	Bunkeflostrand
Sweden	Vårdcentralen Tåbelund	Eslöv
Sweden	Närhälsan Fristad vårdcentral	Fristad
Sweden	Vårdcentralen Lessebo	Lessebo
Sweden	Capio Citykliniken Malmö Limhamn	Limhamn
Sweden	Löddeköpinge vårdcentral	Löddeköpinge
Sweden	Vårdcentralen Lundbergsgatan	Malmö
Sweden	Vårdcentralen Sorgenfrimottagningen	Malmö
Sweden	Närhälsan Sandared vårdcentral	Sandared
Sweden	Vårdcentrlaen Sjöbo	Sjöbo
Sweden	Närhälsan Billingen vårdcentral	Skövde
Sweden	Närhälsan Norrmalm vårdcentral	Skövde
Sweden	Närhälsan Södra Ryd	Skövde
Sweden	Capio vårdcentralen Hovshaga	Växjö
Sweden	Vårdcentrlaen Strandbjörket	Växjö

Sponsors (1)

Lead Sponsor	Collaborator
Ass. Prof. Katarina Hedin

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical cure	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).	5-7 days after discontinuation of treatment
Secondary	Bacteriological cure	Difference between treatment groups in the rate of bacteriological cure, defined as absence of GAS in culture.	5-7 days after discontinuation of treatment
Secondary	Frequency of relapses		1 month after discontinuation of treatment
Secondary	Frequency of complications		Within 3 months after discontinuation of treatment