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

Information source: Abbott
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Bacterial Sinusitis (ABS)

Intervention: Clarithromycin (Drug); Amoxicillin (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

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).

Clinical Details

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

Study design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment

Primary outcome: Clinical Response

Secondary outcome: Radiographic Response

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Thessaloniki 56430, Greece

Patra 26500, Greece

Athens 11522, Greece

Athens 115 27, Greece

Piraeus 18454, Greece

Thessaloniki 54636, Greece

Veszprem H-8200, Hungary

Salgotarjan H-3100, Hungary

Szombathely H-9700, Hungary

Budapest H-1096, Hungary

Budapest H-1062, Hungary

Budapest H-1097, Hungary

Budapest H-1106, Hungary

Palermo 90127, Italy

Pavia 27100, Italy

Genova 16132, Italy

Catania 95124, Italy

Padova 35128, Italy

Vilnius LT-2021, Lithuania

Vilnius LT-2014, Lithuania

Kaunas LT-3007, Lithuania

Vilnius LT-2025, Lithuania

Bydgoszcz 85-090, Poland

Bialystok 15-276, Poland

Lublin 20-954, Poland

Gliwice 44-100, Poland

Jelenia Gora 58-506, Poland

Wroclaw 51-124, Poland

Wroclaw 50-368, Poland

Bielsko-Biala 43-300, Poland

Bucharest 762631, Romania

Bucharest 773511, Romania

Barcelona 08036, Spain

Madrid 28805, Spain

Valladolid 47002, Spain

Badajoz 06010, Spain

Palma de Mallorca 07014, Spain

Birmingham, Alabama 35235, United States

Phoenix, Arizona 85014, United States

La Jolla, California 92037, United States

San Luis Obispo, California 93405, United States

Clovis, California 93611, United States

Coeur d'Alene, Idaho 83814, United States

Charlotte, North Carolina 28210, United States

Columbus, Ohio 43235, United States

Toronto, Ontario M9W 4L6, Canada

Kitchener, Ontario N2C 2N9, Canada

Eugene, Oregon 97404, United States

Sherbrooke, Quebec J1J 2B8, Canada

Saskatoon, Saskatchewan S7H 0W6, Canada

Johnson City, Tennessee 37601, United States

San Antonio, Texas 78209, United States

Spokane, Washington 99216, United States

Additional Information

Starting date: May 2003
Last updated: March 26, 2008

Page last updated: June 20, 2008

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