E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
J03.0 Pharyngotonsillitis |
J03.0 Faryngotonsillit |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine if PcV compared to no antibiotic treatment (care as usual) reduces the duration of symptoms in patients with severe (Centor score 3-4), GAS-negative AT |
Att studera om PcV jämfört med ingen antibiotika behandling reducerar durationen av symtom hos patienter med GAS-negativ akut tonsillit och 3-4 Centorkriterier |
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E.2.2 | Secondary objectives of the trial |
Intensity of symptoms Days with sick-leave Adverse envent Subgroup analysis on patients positiv for group C and G streptococci and F. necrophorum
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Intensitet på symtom Dagar med sjukfrånvaro Biverkningar subgruppsanalyser på patienter positiva för grupp C och G streptokocker samt F. necroporum |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Sore throat and or pain on swallowing Centor score 3-4: absence of cough, anamnestic fever (temperature above 38.5°C), tender lymphadenitis, and tonsillar exudates (one or both tonsils) Duration of symptoms < 8 days A RADT for group A streptococcus taken
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Ont i halsen eller smärta vid sväljning Centor score 3-4: frånvaro av hosta, anamnestisk feber (temperatur över 38.5°C), ömmade adeniter och beläggningar på tonsillerna Symtomduration < 8 dagar RADT för group A streptococcus tagen |
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E.4 | Principal exclusion criteria |
Ongoing antibiotic treatment Known or suspected allergies to penicillin. Strong suspicion of mononucleosis and positive point of care test. Suspicion of peritonsillar abscess or indication for admittance.
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Pågående antibiotikabehandling Känd eller misstänkt allergi för penicillin Stark misstanke om mononukleos och positiv snabbtest Misstanke om peritonsillit eller indikation för remittering till sjukhus
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E.5 End points |
E.5.1 | Primary end point(s) |
Differences in number of days from inclusion to resolution of symptoms |
Skillnader i antal dagar med symtom från inklusion till symtomfrihet |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Diary at day 10 |
Dagbok 10 |
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E.5.2 | Secondary end point(s) |
The possible change in the self-reported items of symptoms on the rating scale for each of the days 2 through 10 The number of days the patient needs to stay at home from work/school. Number of day with adverse events |
Förändring av självrapporterade besvär på en ratingskala dag 2 till 10 Antal dagar patienten behöver stanna hemma från arbete/skola Antal dagar med biverkningar
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Diary at day 10 at follow-up vist after 18-24 days at follow-up after 30 days at follow-up after 3 months |
Dagbok dag 10 vid uppföljningsbesök dag 18-24 vid uppföljning efter 30 dagar vid uppföljningen efter 3 månader |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Två randomiserade grupper och dessutom en referensgrupp och en bortfallsgrupp |
Two randomized groups furthermore one reference group and one drop out group |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Ingen antibiotikabehandling |
No antibiotic treatment |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |