Penicillin and Metronidazole in Treatment of Peritonsillar Abscess

This study has been completed.
Sponsor:
Information provided by:
Helsinki University Central Hospital
ClinicalTrials.gov Identifier:
NCT01255670
First received: December 6, 2010
Last updated: April 8, 2011
Last verified: December 2010
  Purpose

Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage we perform a prospective, double blind, placebo-controlled, randomised study on 200 adult patients with peritonsillar abscess. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence and analyzed.


Condition Intervention
Peritonsillar Abscess
Drug: penicillin and metronidazole in peritonsillar abscess

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Penicillin and Metronidazole in Treatment of Peritonsillar Abscess - Prospective, Double-blind, Randomized, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Helsinki University Central Hospital:

Primary Outcome Measures:
  • Efficacy of metronidazole in addition to penicillin in preventing the recurrence of peritonsillar abscess [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Does metronidazole in addition to penicillin enhance the recovery of peritonsillar abscess [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: February 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Medicillin
  • Flagyl
  • 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:
  • Medicillin
  • Flagyl
  • Tricozol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01255670

Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
Principal Investigator: Karin V Blomgren, MD, PhD consultant
  More Information

No publications provided

Responsible Party: Dr Karin Blomgren, consultant, specialist in otorhinolaryngology
ClinicalTrials.gov Identifier: NCT01255670     History of Changes
Other Study ID Numbers: 224/13/03/02/2009
Study First Received: December 6, 2010
Last Updated: April 8, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Helsinki University Central Hospital:
Peritonsillar Abscess
Quinsy
Penicillin
Metronidazole
Recurrence

Additional relevant MeSH terms:
Abscess
Peritonsillar Abscess
Suppuration
Infection
Inflammation
Pathologic Processes
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 22, 2014