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

Sponsor

Abbott (Industry)

Overall Status

Completed

CT.gov ID

NCT00644553

Collaborator

(none)

437

Enrollment

Locations

Arms

8.2

Patients Per Site

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Acute Bacterial Sinusitis (ABS)	Drug: Clarithromycin Drug: Amoxicillin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

437 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2003

Actual Primary Completion Date :

Mar 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A	Drug: Clarithromycin Clarithromycin Extended-Release 500 mg tablet (2 tablets QD) Other Names: ABT-268 Biaxin
Active Comparator: B	Drug: Amoxicillin Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID) Other Names: amoxicillin-clavulanate

Arm

Intervention/Treatment

Active Comparator: A

Drug: Clarithromycin

Clarithromycin Extended-Release 500 mg tablet (2 tablets QD)

Other Names:

ABT-268

Biaxin

Active Comparator: B

Drug: Amoxicillin

Amoxicillin-clavulanate 875/125 mg tablet (1 tablet BID)

Other Names:

amoxicillin-clavulanate

Outcome Measures

Primary Outcome Measures

Clinical Response [33 days]

Secondary Outcome Measures

Radiographic Response [33 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35235
2	Phoenix	Arizona	United States	85014
3	Clovis	California	United States	93611
4	La Jolla	California	United States	92037
5	San Luis Obispo	California	United States	93405
6	Coeur d'Alene	Idaho	United States	83814
7	Charlotte	North Carolina	United States	28210
8	Columbus	Ohio	United States	43235
9	Eugene	Oregon	United States	97404
10	Johnson City	Tennessee	United States	37601
11	San Antonio	Texas	United States	78209
12	Spokane	Washington	United States	99216
13	Kitchener	Ontario	Canada	N2C 2N9
14	Toronto	Ontario	Canada	M9W 4L6
15	Sherbrooke	Quebec	Canada	J1J 2B8
16	Saskatoon	Saskatchewan	Canada	S7H 0W6
17	Athens		Greece	115 27
18	Athens		Greece	11522
19	Patra		Greece	26500
20	Piraeus		Greece	18454
21	Thessaloniki		Greece	54636
22	Thessaloniki		Greece	56430
23	Budapest		Hungary	H-1062
24	Budapest		Hungary	H-1096
25	Budapest		Hungary	H-1097
26	Budapest		Hungary	H-1106
27	Salgotarjan		Hungary	H-3100
28	Szombathely		Hungary	H-9700
29	Veszprem		Hungary	H-8200
30	Catania		Italy	95124
31	Genova		Italy	16132
32	Padova		Italy	35128
33	Palermo		Italy	90127
34	Pavia		Italy	27100
35	Kaunas		Lithuania	LT-3007
36	Vilnius		Lithuania	LT-2014
37	Vilnius		Lithuania	LT-2021
38	Vilnius		Lithuania	LT-2025
39	Bialystok		Poland	15-276
40	Bielsko-Biala		Poland	43-300
41	Bydgoszcz		Poland	85-090
42	Gliwice		Poland	44-100
43	Jelenia Gora		Poland	58-506
44	Lublin		Poland	20-954
45	Wroclaw		Poland	50-368
46	Wroclaw		Poland	51-124
47	Bucharest		Romania	762631
48	Bucharest		Romania	773511
49	Badajoz		Spain	06010
50	Barcelona		Spain	08036
51	Madrid		Spain	28805
52	Palma de Mallorca		Spain	07014
53	Valladolid		Spain	47002