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

NCT ID: NCT02712307

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 433 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-06-30

Brief 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.

Conditions

Tonsillitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

5 days

Phenoxymethylpenicillin 800 mg x 4 for 5 days

Group Type: EXPERIMENTAL

Phenoxymethylpenicillin

Intervention Type: DRUG

10 days

Phenoxymethylpenicillin 1000 mg x 3 for 10 days

Group Type: ACTIVE_COMPARATOR

Phenoxymethylpenicillin

Intervention Type: DRUG

Interventions

Phenoxymethylpenicillin

Intervention Type: DRUG

Other Intervention Names

Penicillin V

Eligibility Criteria

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).

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ass. Prof. Katarina Hedin

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ass. Prof. Katarina Hedin

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sigvard Mölstad, Professor

Role: PRINCIPAL_INVESTIGATOR

Lund University

Katarina Hedin, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Research and Development, Region Kronoberg and Lund University

Pär-Daniel Sundvall, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Research and Development Unit, Primary Health Care in Southern Älvsborg County and University of Gothenburg

Locations

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 Sorgenfrimottagningen

Malmo, , Sweden

Vårdcentralen Lundbergsgatan

Malmo, , 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

Vårdcentrlaen Strandbjörket

Vaxjo, , Sweden

Capio vårdcentralen Hovshaga

Vaxjo, , Sweden

Countries

Sweden

References

Tell D, Tyrstrup M, Edlund C, Rystedt K, Skoog Stahlgren G, Sundvall PD, Hedin K. Clinical course of pharyngotonsillitis with group A streptococcus treated with different penicillin V strategies, divided in groups of Centor Score 3 and 4: a prospective study in primary care. BMC Infect Dis. 2022 Nov 11;22(1):840. doi: 10.1186/s12879-022-07830-4.

Reference Type: DERIVED

PMID: 36368940 (View on PubMed)

Skoog Stahlgren G, Tyrstrup M, Edlund C, Giske CG, Molstad S, Norman C, Rystedt K, Sundvall PD, Hedin K. Penicillin V four times daily for five days versus three times daily for 10 days in patients with pharyngotonsillitis caused by group A streptococci: randomised controlled, open label, non-inferiority study. BMJ. 2019 Oct 4;367:l5337. doi: 10.1136/bmj.l5337.

Reference Type: DERIVED

PMID: 31585944 (View on PubMed)

Other Identifiers

2015-001752-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FoHM/Tonsillit2015

Identifier Type: -

Identifier Source: org_study_id