NCT02712307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2015

Typical duration for phase_4

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

2.4 years

First QC Date

March 4, 2016

Last Update Submit

November 9, 2018

Conditions

Tonsillitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Bacteriological cure

    5-7 days after discontinuation of treatment

  • Frequency of relapses

    1 month after discontinuation of treatment

  • Frequency of complications

    Within 3 months after discontinuation of treatment

Study Arms (2)

5 days

EXPERIMENTAL

Phenoxymethylpenicillin 800 mg x 4 for 5 days

Drug: Phenoxymethylpenicillin

10 days

ACTIVE COMPARATOR

Phenoxymethylpenicillin 1000 mg x 3 for 10 days

Drug: Phenoxymethylpenicillin

Interventions

PhenoxymethylpenicillinDRUG
Also known as: Penicillin V
10 days5 days

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Signs of serious infection.
  • Known hypersensitivity against penicillin.
  • Chronic disease with effect on the immune response.
  • Immunosuppressive treatment.
  • Streptococcal tonsillitis within one month (relapse).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Alvesta vårdcentral

Alvesta, 342 30, Sweden

Location

Närhälsan Bollebygd vårdcentral

Bollebygd, 517 36, Sweden

Location

Capio Citykliniken Bunkeflo Hyllie

Bunkeflostrand, 21840, Sweden

Location

Vårdcentralen Tåbelund

Eslöv, 241 31, Sweden

Location

Närhälsan Fristad vårdcentral

Fristad, 513 33, Sweden

Location

Vårdcentralen Lessebo

Lessebo, 360 50, Sweden

Location

Capio Citykliniken Malmö Limhamn

Limhamn, 216 16, Sweden

Location

Löddeköpinge vårdcentral

Löddeköpinge, 24630, Sweden

Location

Vårdcentralen Sorgenfrimottagningen

Malmo, 214 33, Sweden

Location

Vårdcentralen Lundbergsgatan

Malmo, 21715, Sweden

Location

Närhälsan Sandared vårdcentral

Sandared, 518 32, Sweden

Location

Vårdcentrlaen Sjöbo

Sjöbo, 27531, Sweden

Location

Närhälsan Billingen vårdcentral

Skövde, 541 41, Sweden

Location

Närhälsan Norrmalm vårdcentral

Skövde, 541 41, Sweden

Location

Närhälsan Södra Ryd

Skövde, 541 64, Sweden

Location

Vårdcentrlaen Strandbjörket

Vaxjo, 351 85, Sweden

Location

Capio vårdcentralen Hovshaga

Vaxjo, 35261, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 36368940DERIVED

  • 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.

    PMID: 31585944DERIVED

MeSH Terms

Conditions

Tonsillitis

Interventions

Penicillin V

Condition Hierarchy (Ancestors)

PharyngitisRespiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Penicillinsbeta-LactamsLactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Sigvard Mölstad, Professor

    Lund University

    PRINCIPAL INVESTIGATOR

  • Katarina Hedin, MD PhD

    Department of Research and Development, Region Kronoberg and Lund University

    PRINCIPAL INVESTIGATOR

  • Pär-Daniel Sundvall, MD PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 18, 2016

Study Start

September 1, 2015

Primary Completion

February 1, 2018

Study Completion

June 1, 2018

Last Updated

November 14, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(17)