Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis

March 26, 2008 updated by: Abbott

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
437

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kitchener, Ontario, Canada, N2C 2N9
      • Toronto, Ontario, Canada, M9W 4L6
    • Quebec
      • Sherbrooke, Quebec, Canada, J1J 2B8
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7H 0W6
  • Greece
      • Athens, Greece, 115 27
      • Athens, Greece, 11522
      • Patra, Greece, 26500
      • Piraeus, Greece, 18454
      • Thessaloniki, Greece, 54636
      • Thessaloniki, Greece, 56430
  • Hungary
      • Budapest, Hungary, H-1106
      • Budapest, Hungary, H-1097
      • Budapest, Hungary, H-1096
      • Budapest, Hungary, H-1062
      • Salgotarjan, Hungary, H-3100
      • Szombathely, Hungary, H-9700
      • Veszprem, Hungary, H-8200
  • Italy
      • Catania, Italy, 95124
      • Genova, Italy, 16132
      • Padova, Italy, 35128
      • Palermo, Italy, 90127
      • Pavia, Italy, 27100
  • Lithuania
      • Kaunas, Lithuania, LT-3007
      • Vilnius, Lithuania, LT-2014
      • Vilnius, Lithuania, LT-2021
      • Vilnius, Lithuania, LT-2025
  • Poland
      • Bialystok, Poland, 15-276
      • Bielsko-Biala, Poland, 43-300
      • Bydgoszcz, Poland, 85-090
      • Gliwice, Poland, 44-100
      • Jelenia Gora, Poland, 58-506
      • Lublin, Poland, 20-954
      • Wroclaw, Poland, 51-124
      • Wroclaw, Poland, 50-368
  • Romania
      • Bucharest, Romania, 762631
      • Bucharest, Romania, 773511
  • Spain
      • Badajoz, Spain, 06010
      • Barcelona, Spain, 08036
      • Madrid, Spain, 28805
      • Palma de Mallorca, Spain, 07014
      • Valladolid, Spain, 47002
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35235
    • Arizona
      • Phoenix, Arizona, United States, 85014
    • California
      • Clovis, California, United States, 93611
      • La Jolla, California, United States, 92037
      • San Luis Obispo, California, United States, 93405
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83814
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
    • Ohio
      • Columbus, Ohio, United States, 43235
    • Oregon
      • Eugene, Oregon, United States, 97404
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
    • Texas
      • San Antonio, Texas, United States, 78209
    • Washington
      • Spokane, Washington, United States, 99216

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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
    • 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.

Exclusion Criteria:

  • 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
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: A
Drug: Clarithromycin
Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)
Other Names:
  • Biaxin
  • ABT-268
ACTIVE_COMPARATOR: B
Drug: Amoxicillin
Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)
Other Names:
  • amoxicillin-clavulanate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Clinical Response
Time Frame: 33 days
33 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Radiographic Response
Time Frame: 33 days
33 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2003

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2004

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • M02-524

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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