Penicillin and Metronidazole in Treatment of Peritonsillar Abscess

Study Overview
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Brief Summary
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Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence are analyzed.

Official Title
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Penicillin and Metronidazole in Treatment of Peritonsillar Abscess - Prospective, Double-blind, Randomized, Placebo-controlled Study

Conditions
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Peritonsillar Abscess

Intervention / Treatment
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* Drug: penicillin and metronidazole in peritonsillar abscess


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referring doctor suspects peritonsillar abscess patient is voluntary patient has daily access to his/her e-mail patient speaks and understands Finnish of Swedish female patients have adequate birth-control method patient has peritonsillar abscess Exclusion Criteria: allergy to penicillin allergy to metronidazole use of metronidazole in preceding one month pregnancy breast-feeding renal insufficiency liver insufficiency alcoholism (drunk at least once a week) participant in another clinical trial at the moment treatment of peritonsillar abscess requires in-patient care tonsillectomy during the next 30 days army recruit

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: penicillin and metronidazole<br>After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess | Drug: penicillin and metronidazole in peritonsillar abscess<br>* Peroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days<br>* Other names: Tricozol;|
| Placebo Comparator: penicillin and placebo<br>After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess | Drug: penicillin and metronidazole in peritonsillar abscess<br>* Peroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days<br>* Other names: Tricozol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Recurrence of Peritonsillar Abscess | Number of participants with recurrence of peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo. | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Recovering From Peritonsillar Abscess | Number of participants recovering from peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritonsillar Abscess, Quinsy, Penicillin, Metronidazole, Recurrence