Acute Bacterial SinusitisPhase 4NCT00147914
Comparison Study Between Cefdinir & Amoxicilline/Clavulanate in Acute Sinusitis and Assessment of Quality of Life
A Phase 4 study testing Cefdinir (drug) and amoxicillin/clavulanate in people with Acute Bacterial Sinusitis, run by University of Chicago at 1 site in United States.
Trial summary
This study is a comparison between two commonly used antibiotics (Cefdinir vs. Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life. The hypothesis is that the two treatments would be at the least equivalent based on clinical outcome measures of improvement in quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Bacterial Sinusitis
- What is being tested?
- Cefdinir (drug) and amoxicillin/clavulanate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to 18 Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Male and female outpatient adults greater than 18 years old fulfilling the case definition for acute bacterial sinusitis
- Case definition includes clinical signs and symptoms, radiographic findings and collection of purulent material from the sinus
Who cannot join
- Symptoms less than 7 days and more than 3 weeks
- History of sinus surgery within 3 months
- History of frequent sinus infections (more than 2 episodes within the last 6 months)
- History of kidney and liver disease
- Pregnant and nursing women
- Pre-existing disease that could predispose to sinus infections (cystic fibrosis or nasal polyps
- Immunosuppressed patients
- History of allergy to either drug. Patients with a documented history of allergies to either penicillin or cephalosporins will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Study Between Cefdinir and Amoxicilline/Clavulanate in Patients With Acute Sinusitis and Assessment of Quality of Life (QOL)
This study is a comparison between two commonly used antibiotics (Cefdinir vs. Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life. The hypothesis is that the two treatments would be at the least equivalent based on clinical outcome measures of improvement in quality of life.
Read the detailed description
The purpose if this investigation is to evaluate the rate of improvement ub Quality of LIfe (QOL) in two different medications, a 10-day course of Cefdinir 300 mg PO BID versus a 10-day course of Amoxicillin/Clavulanate 1000 mg/62.5 mg XR BID, in the treatment of acute bacterial sinusitis.
- Conditions
- Acute Bacterial Sinusitis
- Being tested
- Cefdinir (drug), amoxicillin/clavulanate
- Keywords
- Acute bacterial sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefdinir (drug)Drug
cefdinir 300mg per orally twice daily for 10 days
amoxicillin/clavulanateDrug
1000mg /62.5mg extended release per orally twice daily for 10 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | cefdinir Receives: Drug: Cefdinir (drug) |
| 2 | Active comparator | amoxicillin/clavulanate Receives: Drug: amoxicillin/clavulanate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in quality of life
Measured: At baseline and within 1 week of completing treatment
SNOT 20 questionnaire
Measured: At baseline and within 1 week of completing treatment
Secondary outcomes (1)
Clinical signs and symptoms alleviated
Measured: At baseline and within 1 week of completing treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startFeb 2005
- Primary completionFeb 2007
- Study completion18 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Bacterial SinusitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacquelynne Corey, M.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147914
- Sponsor's protocol ID
- 11791A
- Status last verified
- May 2017
- First submitted
- 2 Sep 2005
- Last updated
- 2 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tantilipikorn P, Fritz M, Tanabodee J, Lanza DC, Kennedy DW. A comparison of endoscopic culture techniques for chronic rhinosinusitis. Am J Rhinol. 2002 Sep-Oct;16(5):255-60.
PubMed 12422969Vaidya AM, Chow JM, Stankiewicz JA, Young MR, Mathews HL. Correlation of middle meatal and maxillary sinus cultures in acute maxillary sinusitis. Am J Rhinol. 1997 Mar-Apr;11(2):139-43. doi: 10.2500/105065897782537133.
PubMed 9129756
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Study Between Cefdinir and Amoxicilline/Clavulanate in Patients With Acute Sinusitis and Assessment of Quality of Life (QOL)
- ClinicalTrials.gov ID
- NCT00147914
- Acronym / sponsor ID
- 11791A
- Conditions
- Acute Bacterial Sinusitis
- Keywords
- Acute bacterial sinusitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- 18 Feb 2017 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a comparison between two commonly used antibiotics (Cefdinir vs. Amoxicillin/Clavulanate) in patients with acute sinus infection, surveying quality of life. The hypothesis is that the two treatments would be at the least equivalent based on clinical outcome measures of improvement in quality of life.
Detailed description
The purpose if this investigation is to evaluate the rate of improvement ub Quality of LIfe (QOL) in two different medications, a 10-day course of Cefdinir 300 mg PO BID versus a 10-day course of Amoxicillin/Clavulanate 1000 mg/62.5 mg XR BID, in the treatment of acute bacterial sinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Cefdinir (drug)cefdinir |
| 2 | Active comparator | Drug: amoxicillin/clavulanateamoxicillin/clavulanate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female outpatient adults greater than 18 years old fulfilling the case definition for acute bacterial sinusitis
- Case definition includes clinical signs and symptoms, radiographic findings and collection of purulent material from the sinus
Key exclusion criteria (8 listed)
- Symptoms less than 7 days and more than 3 weeks
- History of sinus surgery within 3 months
- History of frequent sinus infections (more than 2 episodes within the last 6 months)
- History of kidney and liver disease
- Pregnant and nursing women
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 |
|---|---|---|
| Cefdinir (drug)cefdinir 300mg per orally twice daily for 10 days | Drug | 1 |
| amoxicillin/clavulanate1000mg /62.5mg extended release per orally twice daily for 10 days | Drug | 2 |
Primary outcome
Improvement in quality of life
Time frame: At baseline and within 1 week of completing treatment
SNOT 20 questionnaire
Time frame: At baseline and within 1 week of completing treatment
1 secondary outcome
Clinical signs and symptoms alleviated
Time frame: At baseline and within 1 week of completing treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2017.
- Background: PubMed 12422969Tantilipikorn P, Fritz M, Tanabodee J, Lanza DC, Kennedy DW. A comparison of endoscopic culture techniques for chronic rhinosinusitis. Am J Rhinol. 2002 Sep-Oct;16(5):255-60.
- Background: PubMed 9129756Vaidya AM, Chow JM, Stankiewicz JA, Young MR, Mathews HL. Correlation of middle meatal and maxillary sinus cultures in acute maxillary sinusitis. Am J Rhinol. 1997 Mar-Apr;11(2):139-43. doi: 10.2500/105065897782537133.
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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.
Jacquelynne Corey, M.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefdinir (drug) and amoxicillin/clavulanate in people with Acute Bacterial Sinusitis, run by University of Chicago at 1 site in United States.
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 2 inclusion and 8 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 2 May 2017. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in quality of life (time frame: At baseline and within 1 week of completing treatment). The study lists 2 primary outcomes in all. 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 NCT00147914, which also lists 2 linked publications.
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 2 May 2017.