Peritonsillar AbscessNCT01255670
Penicillin and Metronidazole in Treatment of Peritonsillar Abscess
A study testing penicillin and metronidazole in peritonsillar abscess in people with Peritonsillar Abscess, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritonsillar Abscess
- What is being tested?
- penicillin and metronidazole in peritonsillar abscess
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- allergy to penicillin
- allergy to metronidazole
- use of metronidazole in preceding one month
- pregnancy
- breast-feeding
- renal insufficiency
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Penicillin and Metronidazole in Treatment of Peritonsillar Abscess - Prospective, Double-blind, Randomized, Placebo-controlled Study
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
- Being tested
- penicillin and metronidazole in peritonsillar abscess
- Keywords
- Peritonsillar Abscess, Quinsy, Penicillin, Metronidazole, Recurrence
- Medical subject headings
- Peritonsillar Abscess, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
penicillin and metronidazole in peritonsillar abscessDrug
Also called Medicillin, Flagyl, Tricozol
Peroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days
| Study group | Role | What they receive |
|---|---|---|
| penicillin and metronidazole | Active comparator | After incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess Receives: 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 Receives: Drug: penicillin and metronidazole in peritonsillar abscess |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 56 days
Secondary outcomes (1)
Number of Participants Recovering From Peritonsillar Abscess
Number of participants recovering from peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startFeb 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritonsillar AbscessStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Blomgren, Helsinki University Central Hospital
- Investigators
- Karin V Blomgren, MD, PhD, Principal investigator, consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255670
- Sponsor's protocol ID
- 224/13/03/02/2009
- Status last verified
- Apr 2021
- First submitted
- 6 Dec 2010
- Last updated
- 11 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 26968881
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penicillin and Metronidazole in Treatment of Peritonsillar Abscess - Prospective, Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01255670
- Acronym / sponsor ID
- 224/13/03/02/2009
- Conditions
- Peritonsillar Abscess
- Keywords
- Peritonsillar Abscess, Quinsy, Penicillin, Metronidazole, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| penicillin and metronidazole | Active comparator | Drug: penicillin and metronidazole in peritonsillar abscessAfter incision and drainage 100 randomized patients receive penicillin and metronidazole as treatment of peritonsillar abscess |
| penicillin and placebo | Placebo comparator | Drug: penicillin and metronidazole in peritonsillar abscessAfter incision and drainage 100 randomized patients receive penicillin and placebo as treatment of peritonsillar abscess |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- allergy to penicillin
- allergy to metronidazole
- use of metronidazole in preceding one month
- pregnancy
- breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| penicillin and metronidazole in peritonsillar abscessAlso: Medicillin, Flagyl, TricozolPeroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days | Drug | penicillin and metronidazole, penicillin and placebo |
Primary outcome
Number of Participants With Recurrence of Peritonsillar Abscess
Time frame: 56 days
Number of participants with recurrence of peritonsillar abscess having metronidazole in addition to penicillin or penicillin and placebo.
1 secondary outcome
Number of Participants Recovering From Peritonsillar Abscess
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26968881Wiksten 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin V Blomgren, MD, PhD principal investigator
consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing penicillin and metronidazole in peritonsillar abscess in people with Peritonsillar Abscess, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Recurrence of Peritonsillar Abscess (time frame: 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01255670, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.