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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01255670
Other study ID # 224/13/03/02/2009
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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