Penicillin and Metronidazole in Treatment of Peritonsillar Abscess

NCT01255670 | Completed Results

• 1 other identifier: 224/13/03/02/2009
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritonsillar Abscess

Keywords

Peritonsillar Abscess; Quinsy; Penicillin; Metronidazole; Recurrence

Outcome Measures

Primary Outcomes (1)

• 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.

  56 days

Secondary Outcomes (1)

• Number of Participants Recovering From Peritonsillar Abscess

  28 days

Study Arms (2)

penicillin and metronidazole

ACTIVE COMPARATOR

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

Drug: penicillin and metronidazole in peritonsillar abscess

penicillin and placebo

PLACEBO COMPARATOR

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

Drug: penicillin and metronidazole in peritonsillar abscess

Interventions

penicillin and metronidazole in peritonsillar abscess DRUG

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

Also known as: Medicillin, Flagyl, Tricozol

penicillin and metronidazole; penicillin and placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Related Publications (1)

• 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.

  PMID: 26968881 DERIVED

MeSH Terms

Conditions

Peritonsillar Abscess; Recurrence

Interventions

Penicillins; Metronidazole

Condition Hierarchy (Ancestors)

Tonsillitis; Pharyngitis; Respiratory Tract Infections; Infections; Abscess; Suppuration; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Dr. Karin Blomgren
• Organization: Helsinki University Central Hospital

karin.blomgren@hus.fi

+358504271579

Study Officials

• Karin V Blomgren, MD, PhD

  consultant

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Medical Officer in Charge of Research

Study Record Dates

• First Submitted: December 6, 2010
• First Posted: December 7, 2010
• Study Start: February 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 11, 2021
• Results First Posted: May 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)