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

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ClinicalTrials.gov Identifier: NCT02712307
Recruitment Status : Completed
First Posted : March 18, 2016
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
Ass. Prof. Katarina Hedin, Public Health Agency of Sweden

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tonsillitis Drug: Phenoxymethylpenicillin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of 5 and 10 Days Treatment With Phenoxymethylpenicillin for Pharyngotonsillitis Caused by Streptococcus Group A
Actual Study Start Date : September 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tonsillitis

Arms and Interventions
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Arm Intervention/treatment
Experimental: 5 days
Phenoxymethylpenicillin 800 mg x 4 for 5 days
 Drug: Phenoxymethylpenicillin
Other Name: Penicillin V
Active Comparator: 10 days
Phenoxymethylpenicillin 1000 mg x 3 for 10 days
 Drug: Phenoxymethylpenicillin
Other Name: Penicillin V


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712307


Locations
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Sponsors and Collaborators
Ass. Prof. Katarina Hedin
Investigators
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Principal Investigator: 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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ass. Prof. Katarina Hedin, Professor, Public Health Agency of Sweden
ClinicalTrials.gov Identifier: NCT02712307    
Other Study ID Numbers: FoHM/Tonsillit2015
2015-001752-30 ( EudraCT Number )
First Posted: March 18, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Tonsillitis
Pharyngitis
Respiratory Tract Infections
Infections
Pharyngeal Diseases
Stomatognathic Diseases
 Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Penicillins
Penicillin V
Anti-Bacterial Agents
Anti-Infective Agents