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

December 6, 2010
April 8, 2011
February 2010
April 2011   (final data collection date for primary outcome measure)
Efficacy of metronidazole in addition to penicillin in preventing the recurrence of peritonsillar abscess [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01255670 on ClinicalTrials.gov Archive Site
Does metronidazole in addition to penicillin enhance the recovery of peritonsillar abscess [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Penicillin and Metronidazole in Treatment of Peritonsillar Abscess
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 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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
  • Active Comparator: penicillin and metronidazole
    After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess
    Intervention: Drug: penicillin and metronidazole in peritonsillar abscess
  • Placebo Comparator: penicillin and placebo
    After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess
    Intervention: Drug: penicillin and metronidazole in peritonsillar abscess
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
April 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT01255670
224/13/03/02/2009
No
Dr Karin Blomgren, consultant, specialist in otorhinolaryngology
Helsinki University Central Hospital
Not Provided
Principal Investigator: Karin V Blomgren, MD, PhD consultant
Helsinki University Central Hospital
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP