Penicillin and Metronidazole in Treatment of Peritonsillar Abscess

NCT ID: NCT01255670

Last Updated: 2021-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-04-30

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.

Detailed Description

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Conditions

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Peritonsillar Abscess

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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penicillin and metronidazole

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

Group Type ACTIVE_COMPARATOR

penicillin and metronidazole in peritonsillar abscess

Intervention Type DRUG

Peroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days

penicillin and placebo

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

Group Type PLACEBO_COMPARATOR

penicillin and metronidazole in peritonsillar abscess

Intervention Type DRUG

Peroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Medicillin Flagyl Tricozol

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karin Blomgren

Senior Medical Officer in Charge of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karin V Blomgren, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

consultant

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Wiksten JE, Pitkaranta A, Blomgren K. Metronidazole in conjunction with penicillin neither prevents recurrence nor enhances recovery from peritonsillar abscess when compared with penicillin alone: a prospective, double-blind, randomized, placebo-controlled trial. J Antimicrob Chemother. 2016 Jun;71(6):1681-7. doi: 10.1093/jac/dkw038. Epub 2016 Mar 10.

Reference Type DERIVED
PMID: 26968881 (View on PubMed)

Other Identifiers

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224/13/03/02/2009

Identifier Type: -

Identifier Source: org_study_id

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