Acute Bacterial Sinusitis (ABS)Phase 3NCT00644553
Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
A Phase 3 study testing Clarithromycin and Amoxicillin in people with Acute Bacterial Sinusitis (ABS), run by Abbott at 53 sites in 9 countries.
Trial summary
To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Bacterial Sinusitis (ABS)
- What is being tested?
- Clarithromycin and Amoxicillin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 437 participants
- Where
- 53 sitesin 9 countries
- Study dates
- May 2003to Mar 2004
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The female must be non-lactating and at no risk for pregnancy.
- Subject must have a diagnosis of ABS. The diagnosis must be based on the following:
- A sinus radiograph (Water's view) or CT scan with evidence of maxillary opacification or
- Air/fluid levels purulent discharge from the nose
- At least two of the following additional signs and symptoms lasting longer than seven days prior to and no longer than 28 days before Evaluation 1.
- A pre-treatment sample from a sinus puncture or
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- Middle meatus endoscopy must be obtained for bacterial aerobic culture
- Susceptibility testing (applicable only for selected investigative sites).
- Subject must be a suitable candidate for oral antibiotic therapy and able to swallow tablets intact.
Who cannot join
- A medical history of hypersensitivity or allergic reactions to clarithromycin, erythromycin, amoxicillin/clavulanate, any penicillin or any of the macrolide antibiotics.
- History of amoxicillin-clavulanate associated cholestatic jaundicehepatic dysfunction.
- Females who are pregnant or lactating.
- Subject has either of the following:
- Chronic sinusitis (signs and symptoms lasting longer than 28 days immediately prior to Evaluation 1)
- Significant anatomical abnormalities of the sinuses any other infection or
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- Condition which necessitates use of a concomitant systemic antibiotic.
- Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric or endocrine disease, malignancy, or other abnormality (other than the disease being studied).
- Any underlying condition/disease, that would be likely to interfere with the completion of the course of study drug therapy or follow-up.
- Known significant renal or hepatic impairment (or disease).
- Subject who has taken: a systemic antibiotic within 2 weeks before study drug administration or a long-acting injectable antibiotic (e.g., penicillin G benzathine) within 4 weeks before study drug administration.
- Immunocompromised subjects (e.g., neutropenic subjects).
- Subjects with known HIV infection.
- Treatment with any other investigational drug within 4 weeks prior to study drug administration.
Trial locations and contacts
53 sites in 9 countries.
53 sites in 9 countries
United States12 sites
Study site
Birmingham, Alabama, 35235
Study site
Charlotte, North Carolina, 28210
Study site
Clovis, California, 93611
Study site
Coeur d'Alene, Idaho, 83814
Study site
Columbus, Ohio, 43235
Study site
Eugene, Oregon, 97404
Study site
Johnson City, Tennessee, 37601
Study site
La Jolla, California, 92037
Study site
Phoenix, Arizona, 85014
Study site
San Antonio, Texas, 78209
Study site
San Luis Obispo, California, 93405
Study site
Spokane, Washington, 99216
Poland8 sites
Study site
Bialystok, 15-276
Study site
Bielsko-Biala, 43-300
Study site
Bydgoszcz, 85-090
Study site
Gliwice, 44-100
Study site
Jelenia Góra, 58-506
Study site
Lublin, 20-954
Study site
Wroclaw, 50-368
Study site
Wroclaw, 51-124
Hungary7 sites
Study site
Budapest, H-1062
Study site
Budapest, H-1096
Study site
Budapest, H-1097
Study site
Budapest, H-1106
Study site
Salgótarján, H-3100
Study site
Szombathely, H-9700
Study site
Veszprém, H-8200
Greece6 sites
Study site
Athens, 115 27
Study site
Athens, 11522
Study site
Pátrai, 26500
Study site
Piraeus, 18454
Study site
Thessaloniki, 54636
Study site
Thessaloniki, 56430
Italy5 sites
Study site
Catania, 95124
Study site
Genova, 16132
Study site
Padova, 35128
Study site
Palermo, 90127
Study site
Pavia, 27100
Spain5 sites
Study site
Badajoz, 06010
Study site
Barcelona, 08036
Study site
Madrid, 28805
Study site
Palma de Mallorca, 07014
Study site
Valladolid, 47002
Canada4 sites
Study site
Kitchener, Ontario, N2C 2N9
Study site
Saskatoon, Saskatchewan, S7H 0W6
Study site
Sherbrooke, Quebec, J1J 2B8
Study site
Toronto, Ontario, M9W 4L6
Lithuania4 sites
Study site
Kaunas, LT-3007
Study site
Vilnius, LT-2014
Study site
Vilnius, LT-2021
Study site
Vilnius, LT-2025
About this study
Official title: A Phase IIIB/IV Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets vs. Amoxicillin-Clavulanate for the Treatment of Subjects With Acute Bacterial Sinusitis
To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).
- Conditions
- Acute Bacterial Sinusitis (ABS)
- Being tested
- Clarithromycin, Amoxicillin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClarithromycinDrug
Also called ABT-268, Biaxin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
AmoxicillinDrug
Also called amoxicillin-clavulanate
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Clarithromycin |
| B | Active comparator | Not described Receives: Drug: Amoxicillin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Response
Measured: 33 days
Secondary outcomes (1)
Radiographic Response
Measured: 33 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2008 (estimated)
- Study startMay 2003
- Primary completionMar 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Bacterial Sinusitis (ABS)Studies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644553
- Sponsor's protocol ID
- M02-524
- Status last verified
- Mar 2008
- First submitted
- 22 Mar 2008
- Last updated
- 27 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB/IV Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets vs. Amoxicillin-Clavulanate for the Treatment of Subjects With Acute Bacterial Sinusitis
- ClinicalTrials.gov ID
- NCT00644553
- Acronym / sponsor ID
- M02-524
- Conditions
- Acute Bacterial Sinusitis (ABS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- May 2003
- Primary completion
- Mar 2004 (actual)
- First posted
- 27 Mar 2008 (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.
To compare the safety/tolerability and efficacy of a 14-day course of clarithromycin extended-release tablets (2 x 500 mg QD) with that of a 14-day course of amoxicillin-clavulanate tablets (875/125 mg BID) for the treatment of ambulatory subjects with Acute Bacterial Sinusitis (ABS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Clarithromycin |
| B | Active comparator | Drug: Amoxicillin |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- The female must be non-lactating and at no risk for pregnancy.
- Subject must have a diagnosis of ABS. The diagnosis must be based on the following:
- Subject must be a suitable candidate for oral antibiotic therapy and able to swallow tablets intact.
Key exclusion criteria (14 listed)
- A medical history of hypersensitivity or allergic reactions to clarithromycin, erythromycin, amoxicillin/clavulanate, any penicillin or any of the macrolide antibiotics.
- History of amoxicillin-clavulanate associated cholestatic jaundicehepatic dysfunction.
- Females who are pregnant or lactating.
- Subject has either of the following:
- Evidence of uncontrolled clinically significant cardiovascular, pulmonary, metabolic, gastrointestinal, neurological, psychiatric or endocrine disease, malignancy, or other abnormality (other than the disease being studied).
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 |
|---|---|---|
| ClarithromycinAlso: ABT-268, BiaxinClarithromycin Extended-Release 500 mg tablet (2 tablets QD) | Drug | A |
| AmoxicillinAlso: amoxicillin-clavulanateAmoxicillin-clavulanate 875/125 mg tablet (1 tablet BID) | Drug | B |
Primary outcome
Clinical Response
Time frame: 33 days
1 secondary outcome
Radiographic Response
Time frame: 33 days
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 27 Mar 2008.
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.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clarithromycin and Amoxicillin in people with Acute Bacterial Sinusitis (ABS), run by Abbott at 53 sites in 9 countries.
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 9 inclusion and 14 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 27 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Poland, Hungary, Greece, Italy and 4 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Clinical Response (time frame: 33 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Mar 2008.