Penicillin and Metronidazole in Treatment of Peritonsillar Abscess

April 19, 2021 updated by: Karin Blomgren, Helsinki University Central Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: penicillin and metronidazole
After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess
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
Other Names:
  • Flagyl
  • Medicillin
  • Tricozol
Placebo Comparator: penicillin and placebo
After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess
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
Other Names:
  • Flagyl
  • Medicillin
  • Tricozol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Recurrence of Peritonsillar Abscess
Time Frame: 56 days
Number of participants with recurrence of peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
56 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Recovering From Peritonsillar Abscess
Time Frame: 28 days
Number of participants recovering from peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Principal Investigator: Karin V Blomgren, MD, PhD, Consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (Estimate)

December 7, 2010

Study Record Updates

Last Update Posted (Actual)

May 11, 2021

Last Update Submitted That Met QC Criteria

April 19, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 224/13/03/02/2009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peritonsillar Abscess

Clinical Trials on penicillin and metronidazole in peritonsillar abscess

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe