Trial Outcomes & Findings for Penicillin and Metronidazole in Treatment of Peritonsillar Abscess (NCT NCT01255670)
NCT ID: NCT01255670
Last Updated: 2021-05-11
Results Overview
Number of participants with recurrence of peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
56 days
Results posted on
2021-05-11
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
74
|
80
|
|
Overall Study
NOT COMPLETED
|
26
|
20
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
10
|
|
Overall Study
Lost to Follow-up
|
16
|
10
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Penicillin and Metronidazole
n=100 Participants
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.
|
Penicillin and Placebo
n=100 Participants
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.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=200 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
100 Participants
n=100 Participants
|
100 Participants
n=100 Participants
|
200 Participants
n=200 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=100 Participants
|
0 Participants
n=100 Participants
|
0 Participants
n=200 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=100 Participants
|
44 Participants
n=100 Participants
|
91 Participants
n=200 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=100 Participants
|
56 Participants
n=100 Participants
|
109 Participants
n=200 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Finland
|
100 participants
n=100 Participants
|
100 participants
n=100 Participants
|
200 participants
n=200 Participants
|
PRIMARY outcome
Timeframe: 56 daysNumber of participants with recurrence of peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
Outcome measures
| Measure |
Penicillin and Metronidazole
n=100 Participants
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.
|
Penicillin and Placebo
n=100 Participants
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.
|
|---|---|---|
|
Number of Participants With Recurrence of Peritonsillar Abscess
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 28 daysNumber of participants recovering from peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
Outcome measures
| Measure |
Penicillin and Metronidazole
n=84 Participants
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.
|
Penicillin and Placebo
n=90 Participants
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.
|
|---|---|---|
|
Number of Participants Recovering From Peritonsillar Abscess
|
74 Participants
|
80 Participants
|
Adverse Events
Penicillin and Metronidazole
Serious events: 0 serious events
Other events: 61 other events
Deaths: 0 deaths
Penicillin and Placebo
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Penicillin and Metronidazole
n=100 participants at risk
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.
|
Penicillin and Placebo
n=100 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.0%
10/100
|
8.0%
8/100
|
|
Metabolism and nutrition disorders
Diarrhea
|
16.0%
16/100
|
10.0%
10/100
|
|
Nervous system disorders
Dizziness
|
12.0%
12/100
|
16.0%
16/100
|
|
Nervous system disorders
Headache
|
15.0%
15/100
|
12.0%
12/100
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.0%
8/100
|
5.0%
5/100
|
Additional Information
Dr. Karin Blomgren
Helsinki University Central Hospital
Phone: +358504271579
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place