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

Primary Purpose

Tonsillitis

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
Phenoxymethylpenicillin
Sponsored by
Ass. Prof. Katarina Hedin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsillitis

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • Alvesta vårdcentral
  • Närhälsan Bollebygd vårdcentral
  • Capio Citykliniken Bunkeflo Hyllie
  • Vårdcentralen Tåbelund
  • Närhälsan Fristad vårdcentral
  • Vårdcentralen Lessebo
  • Capio Citykliniken Malmö Limhamn
  • Löddeköpinge vårdcentral
  • Vårdcentralen Sorgenfrimottagningen
  • Vårdcentralen Lundbergsgatan
  • Närhälsan Sandared vårdcentral
  • Vårdcentrlaen Sjöbo
  • Närhälsan Billingen vårdcentral
  • Närhälsan Norrmalm vårdcentral
  • Närhälsan Södra Ryd
  • Vårdcentrlaen Strandbjörket
  • Capio vårdcentralen Hovshaga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

5 days

10 days

Arm Description

Phenoxymethylpenicillin 800 mg x 4 for 5 days

Phenoxymethylpenicillin 1000 mg x 3 for 10 days

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
March 4, 2016
Last Updated
November 9, 2018
Sponsor
Ass. Prof. Katarina Hedin
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1. Study Identification

Unique Protocol Identification Number
NCT02712307
Brief Title
Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci
Official Title
A Randomized Controlled Study of 5 and 10 Days Treatment With Phenoxymethylpenicillin for Pharyngotonsillitis Caused by Streptococcus Group A
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ass. Prof. Katarina Hedin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
433 (Actual)

8. Arms, Groups, and Interventions

Arm Title
5 days
Arm Type
Experimental
Arm Description
Phenoxymethylpenicillin 800 mg x 4 for 5 days
Arm Title
10 days
Arm Type
Active Comparator
Arm Description
Phenoxymethylpenicillin 1000 mg x 3 for 10 days
Intervention Type
Drug
Intervention Name(s)
Phenoxymethylpenicillin
Other Intervention Name(s)
Penicillin V
Primary Outcome Measure Information:
Title
Clinical cure
Description
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).
Time Frame
5-7 days after discontinuation of treatment
Secondary Outcome Measure Information:
Title
Bacteriological cure
Description
Difference between treatment groups in the rate of bacteriological cure, defined as absence of GAS in culture.
Time Frame
5-7 days after discontinuation of treatment
Title
Frequency of relapses
Time Frame
1 month after discontinuation of treatment
Title
Frequency of complications
Time Frame
Within 3 months after discontinuation of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sigvard Mölstad, Professor
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katarina Hedin, MD PhD
Organizational Affiliation
Department of Research and Development, Region Kronoberg and Lund University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pär-Daniel Sundvall, MD PhD
Organizational Affiliation
Research and Development Unit, Primary Health Care in Southern Älvsborg County and University of Gothenburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alvesta vårdcentral
City
Alvesta
ZIP/Postal Code
342 30
Country
Sweden
Facility Name
Närhälsan Bollebygd vårdcentral
City
Bollebygd
ZIP/Postal Code
517 36
Country
Sweden
Facility Name
Capio Citykliniken Bunkeflo Hyllie
City
Bunkeflostrand
ZIP/Postal Code
21840
Country
Sweden
Facility Name
Vårdcentralen Tåbelund
City
Eslöv
ZIP/Postal Code
241 31
Country
Sweden
Facility Name
Närhälsan Fristad vårdcentral
City
Fristad
ZIP/Postal Code
513 33
Country
Sweden
Facility Name
Vårdcentralen Lessebo
City
Lessebo
ZIP/Postal Code
360 50
Country
Sweden
Facility Name
Capio Citykliniken Malmö Limhamn
City
Limhamn
ZIP/Postal Code
216 16
Country
Sweden
Facility Name
Löddeköpinge vårdcentral
City
Löddeköpinge
ZIP/Postal Code
24630
Country
Sweden
Facility Name
Vårdcentralen Sorgenfrimottagningen
City
Malmö
ZIP/Postal Code
214 33
Country
Sweden
Facility Name
Vårdcentralen Lundbergsgatan
City
Malmö
ZIP/Postal Code
21715
Country
Sweden
Facility Name
Närhälsan Sandared vårdcentral
City
Sandared
ZIP/Postal Code
518 32
Country
Sweden
Facility Name
Vårdcentrlaen Sjöbo
City
Sjöbo
ZIP/Postal Code
27531
Country
Sweden
Facility Name
Närhälsan Billingen vårdcentral
City
Skövde
ZIP/Postal Code
541 41
Country
Sweden
Facility Name
Närhälsan Norrmalm vårdcentral
City
Skövde
ZIP/Postal Code
541 41
Country
Sweden
Facility Name
Närhälsan Södra Ryd
City
Skövde
ZIP/Postal Code
541 64
Country
Sweden
Facility Name
Vårdcentrlaen Strandbjörket
City
Växjö
ZIP/Postal Code
351 85
Country
Sweden
Facility Name
Capio vårdcentralen Hovshaga
City
Växjö
ZIP/Postal Code
35261
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36368940
Citation
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.
Results Reference
derived
PubMed Identifier
31585944
Citation
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.
Results Reference
derived

Learn more about this trial

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

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