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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| penicillin and metronidazole | Active Comparator | After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess |
|
| penicillin and placebo | Placebo Comparator | After incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Recovering From Peritonsillar Abscess | Number of participants recovering from peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo. | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin V Blomgren, MD, PhD | consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Central Hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26968881 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 56 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karin Blomgren | Helsinki University Central Hospital | +358504271579 | karin.blomgren@hus.fi |
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| ID | Term |
|---|---|
| D000039 | Peritonsillar Abscess |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D014069 | Tonsillitis |
| D010612 | Pharyngitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D010406 | Penicillins |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013457 |
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|
| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 28 days |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 61 |
| 100 |
| EG001 | 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. | 0 | 100 | 0 | 100 | 51 | 100 |
| Diarrhea | Metabolism and nutrition disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D000038 |
| Abscess |
| D013492 | Suppuration |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |