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
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|Condition or disease||Intervention/treatment||Phase|
|Tonsillitis||Drug: Phenoxymethylpenicillin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||433 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: 5 days
Phenoxymethylpenicillin 800 mg x 4 for 5 days
Other Name: Penicillin V
Active Comparator: 10 days
Phenoxymethylpenicillin 1000 mg x 3 for 10 days
Other Name: Penicillin V
- 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).
- 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.
- Frequency of relapses [ Time Frame: 1 month after discontinuation of treatment ]
- Frequency of complications [ Time Frame: Within 3 months after discontinuation of treatment ]
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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|
- Adults, adolescents and children ≥ 6 years of age with verified streptococcal pharyngotonsillitis.
- Signs of serious infection.
- Known hypersensitivity against penicillin.
- Chronic disease with effect on the immune response.
- Immunosuppressive treatment.
- Streptococcal tonsillitis within one month (relapse).
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
|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|
|Responsible Party:||Ass. Prof. Katarina Hedin, Professor, Public Health Agency of Sweden|
|Other Study ID Numbers:||
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|
Respiratory Tract Infections
Respiratory Tract Diseases