Penicillin and Metronidazole in Treatment of Peritonsillar Abscess
Primary Purpose
Peritonsillar Abscess
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
penicillin and metronidazole in peritonsillar abscess
Sponsored by
About this trial
This is an interventional treatment trial for Peritonsillar Abscess focused on measuring Peritonsillar Abscess, Quinsy, Penicillin, Metronidazole, Recurrence
Eligibility 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
Sites / Locations
- Helsinki University Central Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
penicillin and metronidazole
penicillin and placebo
Arm Description
After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess
After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Number of Participants Recovering From Peritonsillar Abscess
Number of participants recovering from peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
Full Information
NCT ID
NCT01255670
First Posted
December 6, 2010
Last Updated
April 19, 2021
Sponsor
Helsinki University Central Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01255670
Brief Title
Penicillin and Metronidazole in Treatment of Peritonsillar Abscess
Official Title
Penicillin and Metronidazole in Treatment of Peritonsillar Abscess - Prospective, Double-blind, Randomized, Placebo-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritonsillar Abscess
Keywords
Peritonsillar Abscess, Quinsy, Penicillin, Metronidazole, Recurrence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
penicillin and metronidazole
Arm Type
Active Comparator
Arm Description
After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess
Arm Title
penicillin and placebo
Arm Type
Placebo Comparator
Arm Description
After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess
Intervention Type
Drug
Intervention Name(s)
penicillin and metronidazole in peritonsillar abscess
Other Intervention Name(s)
Medicillin, Flagyl, Tricozol
Intervention Description
Peroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days
Primary Outcome Measure Information:
Title
Number of Participants With Recurrence of Peritonsillar Abscess
Description
Number of participants with recurrence of peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
Time Frame
56 days
Secondary Outcome Measure Information:
Title
Number of Participants Recovering From Peritonsillar Abscess
Description
Number of participants recovering from peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin V Blomgren, MD, PhD
Organizational Affiliation
consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26968881
Citation
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.
Results Reference
derived
Learn more about this trial
Penicillin and Metronidazole in Treatment of Peritonsillar Abscess
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