Sore Throat Clinical Trial
Official title:
A Randomized Controlled Clinical Trial of Streptococcus Group A-negative Acute Tonsillitis in Primary Health Care - a Comparison of Phenoxymethylpenicillin and no Antibiotic Treatment
Sore throat is the second most common cause of antibiotic prescribing in primary care in
Sweden. Guidelines for sore throat focus on identifying people with sore throat where there
are 3 and 4 specified criteria and where near patient tests identify group A streptococci
(GAS). In these cases, phenoxymethylpenicillin is recommended.
Studies that have identified microorganisms in sore throat show that there are other bacteria
and viruses than GAS, that give similar symptoms and that sometimes no microorganism is
trapped despite pronounced symptoms. In recent years, a bacterium F. necrophorum has been
identified, which is found in increased incidence of sore throat, but it is also found in
healthy individuals. In clinical practice, many patients are treated with penicillin even if
GAS is not captured. This may be because the doctor perceives the patient as sick or because
other bacteria are not caught with a near patient test which causes the doctor to treat
anyway.
The specific aims are to in patients with GAS-negative sore throat and 3 and 4 criteria, aged
15 years and older in primary care, study whether phenoxymethylpenicillin treatment shortens
the duration of the disease, reduces the symptom intensity and sickness absence, and
investigates the importance of other microorganisms than GAS in sore throat.
The study is a randomized controlled trial in which patients with sore throat are randomized
to phenoxymethylpenicillin 3 times daily for 10 days or to no antibiotic therapy. There will
also be and a reference group with severe (Centor score 3-4), GAS-positive acute tonsillitis.
Blood samples for inflammatory and immunological response to infections are taken. Throat
samples for culture of F. necrophorum and streptococcal groups C and G, as well as polymerase
chain reaction (PCR) analysis for bacteria and viruses are also taken at inclusion and at
follow-up.
The outcome will be followed in a patient diary for 10 days and at a return visit after 18-24
days where the clinical outcome is asked for and where the blood- and throat samples are
repeated.
Follow-up will also takes place via e-mail after 1 and 3 months.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04551196 -
Management of Post-Tonsillectomy Pain in Pediatric Patients
|
Phase 3 | |
| Active, not recruiting |
NCT03654742 -
Intracapsular Tonsillectomy in Adults
|
N/A | |
| Completed |
NCT04016051 -
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
|
Phase 3 | |
| Completed |
NCT02712307 -
Study of 5 and 10 Days Treatment With Penicillin Against Sore Throat Caused by Streptococci
|
Phase 4 | |
| Enrolling by invitation |
NCT02205580 -
Continuous Intravenous Sufentanil Infusion for Postoperative Pain Management Following Tonsillectomy or Adeno-tonsillectomy in Children
|
Phase 4 | |
| Completed |
NCT01721486 -
Acetaminophen's Efficacy For Post-operative Pain
|
Phase 4 | |
| Active, not recruiting |
NCT01691690 -
Analgesic Effect of IV Acetaminophen in Tonsillectomies
|
Phase 2 | |
| Completed |
NCT00393744 -
Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in Children
|
Phase 3 | |
| Completed |
NCT00095368 -
APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat
|
Phase 3 | |
| Active, not recruiting |
NCT00136877 -
Tonsillectomy in Recurrent Tonsillitis
|
N/A | |
| Recruiting |
NCT04646525 -
The Relationship Between Covid-19 Infection in Pediatric Patients and Secondary Lymphoid Organs
|
||
| Completed |
NCT01361399 -
Active and Placebo Controlled Study to Test the Efficacy and Safety of an Aspirin-Lidocaine Lozenge in the Symptomatic Treatment of Sore Throat Associated With a Common Cold
|
Phase 3 | |
| Recruiting |
NCT03137823 -
Diagnosis of GABHS Tonsillitis - Comparison Between Culture From Tonsills and Culture From the Bucal Surface
|
N/A | |
| Completed |
NCT02571075 -
Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea
|
N/A | |
| Completed |
NCT00547391 -
Recurrent Throat Infections and Tonsillectomy
|
Phase 4 | |
| Completed |
NCT00242281 -
APC-111 MP Tablet Once a Day vs.Penicillin VK Four Times a Day Both for 10 Days in Patients With Strep Throat
|
Phase 3 | |
| Completed |
NCT01465009 -
Placebo and Active Controlled Study to Compare the Efficacy of Aspirin and Paracetamol in Treatment of Sore Throat Associated With a Common Cold
|
Phase 4 | |
| Recruiting |
NCT04164511 -
Does Ice Cream Help With Post-tonsillectomy Pain
|
||
| Completed |
NCT04653376 -
Relationship of Endoplasmic Reticulum Stress and Tonsillar Tissue Diseases
|
||
| Recruiting |
NCT05656365 -
Evaluating the Genetics and Immunology of Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Cervical Adenitis (PFAPA) Syndrome and Other Tonsil Disorders
|