Penicillin and Metronidazole in Treatment of Peritonsillar Abscess

Helsinki University Central Hospital (HUCH)

Status: Completed

Conditions: Peritonsillar Abscess

Treatments: Drug: penicillin and metronidazole in peritonsillar abscess

Study type: Interventional

Funder types: Other

Identifiers

NCT01255670

224/13/03/02/2009

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

penicillin and metronidazole

Active Comparator group

Description:

After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess

Treatment:

Drug: penicillin and metronidazole in peritonsillar abscess

penicillin and placebo

Placebo Comparator group

Description:

After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess

Treatment:

Drug: penicillin and metronidazole in peritonsillar abscess