Clinical trial NCT00644553: Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets Versus Amoxicillin-Clavulanate for the Treatment of Acute Bacterial Sinusitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Bacterial Sinusitis (ABS)
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-27
Enrollment: 437
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility 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.

Primary outcomes:
measure: Clinical Response
timeFrame: 33 days
Secondary outcomes:
measure: Radiographic Response
timeFrame: 33 days
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Clovis
country: United States
state: California
city: La Jolla
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: Coeur d'Alene
country: United States
state: Idaho
city: Charlotte
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Eugene
country: United States
state: Oregon
city: Johnson City
country: United States
state: Tennessee
city: San Antonio
country: United States
state: Texas
city: Spokane
country: United States
state: Washington
city: Kitchener
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Sherbrooke
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Athens
country: Greece
city: Athens
country: Greece
city: Patra
country: Greece
city: Piraeus
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Salgotarjan
country: Hungary
city: Szombathely
country: Hungary
city: Veszprem
country: Hungary
city: Catania
country: Italy
city: Genova
country: Italy
city: Padova
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Vilnius
country: Lithuania
city: Bialystok
country: Poland
city: Bielsko-Biala
country: Poland
city: Bydgoszcz
country: Poland
city: Gliwice
country: Poland
city: Jelenia Gora
country: Poland
city: Lublin
country: Poland
city: Wroclaw
country: Poland
city: Wroclaw
country: Poland
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Badajoz
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Palma de Mallorca
country: Spain
city: Valladolid
country: Spain
Study officials:
References: