Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis | NCT00656747 | Trialant

Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis | NCT00656747 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

Outpatients with chronic bronchitis

Male or female subjects, >=60 years old

Post bronchodilator forced expiratory volume in one second (FEV1) less than or equal to 60% predicted and FEV1 / forced vital capacity (FVC) less than 70% at enrollment

Documented history of 2 or more AECB episodes, within 12 months of study enrollment, requiring a course of systemic antibiotics and/or systemic corticosteroids

All symptoms/signs must be present and confirmed by the Investigator:

increase in dyspnea

purulent sputum

increase in sputum volume

Current or past cigarette smoker with equal to or greater than 20 pack year smoking history

Subjects must be exacerbation free for at least 30 days prior to enrollment

Subjects must be willing and able to complete the questionnaires and subject booklet without assistance

Exclusion Criteria:

Known hypersensitivity to quinolones, ß lactams, or to any of the excipients of the study drugs

Known to have congenital or acquired QT prolongation

Known to have clinically relevant bradycardia

Known to have clinically relevant heart failure with reduced left ventricular ejection fraction

Known to have previous history of symptomatic arrhythmias

Taking QT prolonging drugs, for example Class Ia or III antiarrhythmic agents or other QT prolonging drugs

Known electrolyte disturbances that are not controlled, particularly uncorrected hypokalemia

Known history of hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose galactose malabsorption

History of a tendon disease/disorder

Known history of liver dysfunction (Child-Pugh C), including known elevated transaminase levels (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >5 times the upper limit of normal [5 x ULN])

Known severe renal impairment with glomerular filtration rate of <30 mL/min

Known neutropenia (neutrophil count <1000/mm3) caused by immunosuppressive therapy or malignancy

Known to have Acquired Immunodeficiency Syndrome (AIDS) (CD4 count of <200/mm3), or be human immunodeficiency virus (HIV) positive and receiving highly active anti retroviral therapy (HAART) (testing for HIV is not mandatory)

Known chronic asthma (>15% reversibility or at least 200 mL), bronchial carcinoma, active pulmonary tuberculosis, known diffuse bronchiectasis, cystic fibrosis, or pneumonia (a chest x ray is not mandatory)

Known history of chronic colonization of pathogenic organisms resistant to moxifloxacin and/or amoxicillin clavulanic acid (eg, P. aeruginosa, methicillin resistant Staphylococcus aureus)

Receiving long term (>4 consecutive weeks) systemic corticosteroid treatment (>10 mg/day of prednisolone or equivalent)

Received short course of systemic corticosteroid treatment within 30 days prior to enrollment

Life expectancy of less than 6 months

Receiving systemic antibacterial therapy within 30 days prior to study enrollment

Requiring concomitant systemic antibacterial agents

Requiring home ventilatory support (subjects requiring home/portable oxygen therapy or continuous positive airway pressure (CPAP) for sleep apnea are not excluded) and/or those who have a tracheotomy in situ

History of liver function disorders following previous treatment with amoxicillin-clavulanic acid

Receiving disulfiram therapy

-

Les Escaldes, Andorra

-

Quilmes, Buenos Aires, Argentina

-

San Juan Bautista, Buenos Aires, Argentina

-

Buenos Aires, Ciudad Auton. de Buenos Aires 1426, Argentina

-

Buenos Aires, Ciudad Auton. de Buenos Aires C1424BSF, Argentina

-

Buenos Aires, Ciudad Auton. de Buenos Aires C1425AWC, Argentina

-

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

-

San Miguel de Tucumán, Tucumán Province 4000, Argentina

-

San Miguel de Tucumán, Tucumán Province, Argentina

-

Vicente López, 1638, Argentina

-

Concord, New South Wales 2139, Australia

-

Brisbane, Queensland 4101, Australia

-

Adelaide, South Australia 5041, Australia

-

Woodville, South Australia 5011, Australia

-

Nedlands, Western Australia 6009, Australia

-

Aalst, 9300, Belgium

-

Antwerp, 2018, Belgium

-

Bruxelles - Brussel, 1020, Belgium

-

Halen, 3545, Belgium

-

Lommel, 3920, Belgium

-

Moerkerke, 8340, Belgium

-

Namur, 5000, Belgium

-

Yvoir, 5530, Belgium

-

Juiz de Fora, Minas Gerais 36036-110, Brazil

-

Porto Alegre, Rio Grande do Sul 90610-000, Brazil

-

São Paulo, São Paulo 04032-060, Brazil

-

São Paulo, São Paulo 05403-900, Brazil

-

Calgary, Alberta T2N 4Z6, Canada

-

Edmonton, Alberta T6G 2B7, Canada

-

Edmonton, Alberta T6L 5X8, Canada

-

Kelowna, British Columbia V1Y 8E7, Canada

-

Vancouver, British Columbia V5Z 4E1, Canada

-

Winnipeg, Manitoba R3A 1R8, Canada

-

Winnipeg, Manitoba R3C 0N2, Canada

-

Saint John, New Brunswick E2K 2T8, Canada

-

Saint John, New Brunswick E2M 3W5, Canada

-

Antigonish Nova Scotia, Nova Scotia B2G 2C2, Canada

-

Sydney Mines, Nova Scotia B1V 2Y5, Canada

-

Burlington, Ontario L7R 3X4, Canada

-

Hamilton, Ontario L8N 4A6, Canada

-

London, Ontario N6A 4V2, Canada

-

London, Ontario N6A 5G6, Canada

-

Toronto, Ontario M6H 3M2, Canada

-

Longueuil, Quebec J4N 1E1, Canada

-

Montreal, Quebec H2L 4M1, Canada

-

Sherbrooke, Quebec JIH 4J6, Canada

-

Santiago, Chile

-

Valparaíso, Chile

-

Viña del Mar, Chile

-

Guangzhou, Guangdong 510120, China

-

Guangzhou, Guangdong 510405, China

-

Changsha, Hunan 410013, China

-

Shengyang, Liaoning 110004, China

-

Shenyang, Liaoning 110001, China

-

Chengdu, Sichuan 610041, China

-

Beijing, 100020, China

-

Beijing, 100050, China

-

Shanghai, 200003, China

-

Shanghai, 200040, China

-

Shanghai, 200233, China

-

Tianjin, 300052, China

-

Cali, Cauca Department, Colombia

-

Bogotá, Colombia

-

Bucaramanga, Colombia

-

Cali, Colombia

-

Medellín, Colombia

-

Osijek, 310 00, Croatia

-

Petrinja, 44 250, Croatia

-

Rijeka, 510 00, Croatia

-

Zagreb, 10000, Croatia

-

Kyjov, 697 01, Czechia

-

Lovosice, 410 02, Czechia

-

Neratovice, 227 11, Czechia

-

Pardubice - Trnova, 530 09, Czechia

-

Praha - Malesice, 108 00, Czechia

-

Praha - Troja, 182 00, Czechia

-

Marseille, 13009, France

-

Mont-de-Marsan, 40000, France

-

Nice, 06000, France

-

Perpignan, 66025, France

-

Bad Dürrheim, Baden-Wurttemberg 78073, Germany

-

Augsburg, Bavaria 86150, Germany

-

Cottbus, Brandenburg 03050, Germany

-

Rüdersdorf, Brandenburg 15562, Germany

-

Zossen, Brandenburg 15806, Germany

-

Hamburg, Free and Hanseatic City of Hamburg 20354, Germany

-

Hamburg, Free and Hanseatic City of Hamburg 22305, Germany

-

Frankfurt am Main, Hesse 60318, Germany

-

Frankfurt am Main, Hesse 60389, Germany

-

Fulda, Hesse 36039, Germany

-

Neubrandenburg, Mecklenburg-Vorpommern 17033, Germany

-

Lüdenscheid, North Rhine-Westphalia 58515, Germany

-

Neuwied, Rhineland-Palatinate 56564, Germany

-

Böhlen, Saxony 04564, Germany

-

Delitzsch, Saxony 04509, Germany

-

Dresden, Saxony 01307, Germany

-

Leipzig, Saxony 04207, Germany

-

Leipzig, Saxony 04275, Germany

-

Leipzig, Saxony 04357, Germany

-

Meissen, Saxony 01662, Germany

-

Bad Segeberg, Schleswig-Holstein 23795, Germany

-

Lübeck, Schleswig-Holstein 23552, Germany

-

Berlin, State of Berlin 10365, Germany

-

Berlin, State of Berlin 10717, Germany

-

Berlin, State of Berlin 10969, Germany

-

Berlin, State of Berlin 12043, Germany

-

Berlin, State of Berlin 12203, Germany

-

Berlin, State of Berlin 13597, Germany

-

Berlin, State of Berlin 14059, Germany

-

Athens, Attica 106 76, Greece

-

Mezourlo, Larissa 41110, Greece

-

Rio, Patras 265 04, Greece

-

Athens, 11527, Greece

-

Ioannina, 45500, Greece

-

Hong Kong, Hong Kong

-

Kowloon, Hong Kong

-

Bandung, Indonesia

-

Jakarta, 13230, Indonesia

-

Surabaya, Indonesia

-

Killarney, Kerry, Ireland

-

Longford, Longford, Ireland

-

Enniscorthy, Wexford, Ireland

-

Gorey, Wexford, Ireland

-

Bray, Wicklow, Ireland

-

Pregiato Di Cava Dei Tirreni, Salerno 84013, Italy

-

Busto Arsizio, Varese 21052, Italy

-

Bussolengo, Verona 37012, Italy

-

Ascoli Piceno, 63100, Italy

-

Catania, 95122, Italy

-

Chieti, 66100, Italy

-

Milan, 20123, Italy

-

Milan, 20157, Italy

-

Perugia, 06156, Italy

-

Krāslava, 5601, Latvia

-

Riga, 1009, Latvia

-

Riga, 1011, Latvia

-

Riga, 1050, Latvia

-

Talsu, 3201, Latvia

-

Valmiera, 4201, Latvia

-

Ventspils, LV-3601, Latvia

-

Kaunas, LT-50425, Lithuania

-

Kaunas, Lithuania

-

Klaipėda, LT-94231, Lithuania

-

Šiauliai, 76231, Lithuania

-

Vilnius, LT-06122, Lithuania

-

Vilnius, LT-07156, Lithuania

-

Chihuahua City, Chihuahua 31350, Mexico

-

Guadalajara, Jalisco 44280, Mexico

-

Monterrey, Nuevo León 64718, Mexico

-

Monterrey, Nuevo León 66480, Mexico

-

Huixquilucan, State of Mexico CP 52763, Mexico

-

Mérida, Yucatán 97001, Mexico

-

Zacatecas City, Zacatecas 98608, Mexico

-

Eindhoven, North Brabant 5623 EJ, Netherlands

-

Heerlen, 6419 PC, Netherlands

-

Hoofddorp, 2134 TM, Netherlands

-

Meppel, 7943 KA, Netherlands

-

Utrecht, 3582 KE, Netherlands

-

Karachi, Sindh 74800, Pakistan

-

Islamabad, Pakistan

-

Karachi, 75500, Pakistan

-

Lima, Lima Province LIMA 18, Peru

-

Callao, CALLAO 2, Peru

-

Lima, 31, Peru

-

Lima, 33, Peru

-

Lima, LIMA 27, Peru

-

Lima, Peru

-

Manila, Philippines

-

Quezon City, Philippines

-

Coimbra, Coimbra District 3000-075, Portugal

-

Torres Vedras, Lisbon District 2560-324, Portugal

-

Matosinhos Municipality, Porto District 4454-509, Portugal

-

Vila Nova de Gaia, Porto District 4434-502, Portugal

-

Lisbon, 1169-024, Portugal

-

Lisbon, 1649-035, Portugal

-

Porto, 4200, Portugal

-

S. Martinho Do Bispo, 3041-856, Portugal

-

Santarém, 2005-177, Portugal

-

Port Elizabeth, Eastern Cape 6014, South Africa

-

Bloemfontein, Freestate 9324, South Africa

-

Benoni, Gauteng 1500, South Africa

-

Centurion, Gauteng 0140, South Africa

-

Kempton Park, Gauteng 1610, South Africa

-

Pretoria, Gauteng 0002, South Africa

-

Pretoria, Gauteng 0084, South Africa

-

Pretoria, Gauteng, South Africa

-

Durban, KwaZulu-Natal 4037, South Africa

-

Durban, KwaZulu-Natal 4091, South Africa

-

Thabazimbi, Limpopo 0380, South Africa

-

Witbank, Mpumalanga 1035, South Africa

-

Cape Town, Western Cape 7505, South Africa

-

Paarl, Western Cape 7647, South Africa

-

Somerset West, Western Cape 7130, South Africa

-

Badalona, Barcelona 08916, Spain

-

Barcelona, Barcelona 08034, Spain

-

Barcelona, Barcelona 08036, Spain

-

Sant Boi de Llobregat, Barcelona 08830, Spain

-

Guadalajara, Guadalajara 19002, Spain

-

Palma de Mallorca, Illes Baleares 07010, Spain

-

Madrid, Madrid 28040, Spain

-

Requena, Valencia 46340, Spain

-

Laufen, Basel-Landschaft 4242, Switzerland

-

Oberwil, Basel-Landschaft 4104, Switzerland

-

Aarau, Canton of Aargau 5000, Switzerland

-

Binningen, Canton of Basel-City 4102, Switzerland

-

Bern, Canton of Bern 3004, Switzerland

-

Zurich, Canton of Zurich 8048, Switzerland

-

Zurich, Canton of Zurich 8091, Switzerland

-

Basel, 4031, Switzerland

-

Thun, 3600, Switzerland

-

Wettingen, 5430, Switzerland

-

Chiang Mai, Thailand 50200, Thailand

-

Bangkok, 10330, Thailand

-

Nonthaburi, 11000, Thailand

-

Glasgow, Stratchclyde G3 8YJ, United Kingdom

-

Glasgow, Stratchclyde G45 9AW, United Kingdom

-

Glasgow, Stratchclyde G46 8NY, United Kingdom

-

Glasgow, Stratchclyde G69 7AD, United Kingdom

-

Glasgow, Stratchclyde, United Kingdom

-

Coventry, Warwickshire CV7 8LA, United Kingdom