Penicillin and Metronidazole in Treatment of Peritonsillar Abscess

Peritonsillar Abscess Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01255670
• Other study ID #: 224/13/03/02/2009
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2021
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abscess
• Peritonsillar Abscess

Intervention

Drug:
• penicillin and metronidazole in peritonsillar abscess
Peroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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