Penicillin and Metronidazole in Treatment of Peritonsillar Abscess

Not Applicable

Completed

• Conditions: Peritonsillar Abscess
• Interventions: Drug: penicillin and metronidazole in peritonsillar abscess

• Registration Number: NCT01255670
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-07
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Results First Submitted: 2021-03-18
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-19
• Last Update Submitted: 2021-04-19
• Results First Posted: 2021-05-11
• Last Update Posted: 2021-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
penicillin and metronidazole	penicillin and metronidazole in peritonsillar abscess	After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess
penicillin and placebo	penicillin and metronidazole in peritonsillar abscess	After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess

Primary Outcome Measures

Name	Time	Method
Number of Participants With Recurrence of Peritonsillar Abscess	56 days	Number of participants with recurrence of peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Recovering From Peritonsillar Abscess	28 days	Number of participants recovering from peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland