Peritonsillar Abscess
Conditions
Keywords
Peritonsillar Abscess, Quinsy, Penicillin, Metronidazole, Recurrence
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.
Interventions
DRUGpenicillin 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
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Recurrence of Peritonsillar Abscess | 56 days | Number of participants with recurrence of peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Recovering From Peritonsillar Abscess | 28 days | Number of participants recovering from peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo. |
Countries
Finland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Penicillin and Metronidazole After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess.
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. | 100 |
| Penicillin and Placebo After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess.
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. | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 10 | 10 |
| Overall Study | Lost to Follow-up | 16 | 10 |
Baseline characteristics
| Characteristic | Penicillin and Placebo | Total | Penicillin and Metronidazole |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 100 Participants | 200 Participants | 100 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Finland | 100 participants | 200 participants | 100 participants |
| Sex: Female, Male Female | 44 Participants | 91 Participants | 47 Participants |
| Sex: Female, Male Male | 56 Participants | 109 Participants | 53 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 61 / 100 | 51 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
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.
Time frame: 56 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Penicillin and Metronidazole | Number of Participants With Recurrence of Peritonsillar Abscess | 10 Participants |
| Penicillin and Placebo | Number of Participants With Recurrence of Peritonsillar Abscess | 10 Participants |
p-value: 0.05Fisher Exact
Secondary
Number of Participants Recovering From Peritonsillar Abscess
Number of participants recovering from peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Penicillin and Metronidazole | Number of Participants Recovering From Peritonsillar Abscess | 74 Participants |
| Penicillin and Placebo | Number of Participants Recovering From Peritonsillar Abscess | 80 Participants |
Comparison: Mann-Whitney U-test and Fisher's exact testp-value: 0.05Wilcoxon (Mann-Whitney)