Greatest International Antiinfective Trial With Avelox

NCT00932802 | Completed DMC

• 28 other identifiers: 12219AX04011182812206122141223412213122121221612220122171222512223122291222112218122221223012211122271222812226122351223312224122151223112232
• Study Type: observational
• Target: 50,000
• Locations: 24 countries
• Sites: 24

Brief Summary

The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.

Conditions

Bronchitis, Chronic; Bronchial Diseases

Keywords

Non-Interventional; Observational; NIS; Moxifloxacin; MXF; Avelox; AECB

Outcome Measures

Primary Outcomes (1)

• Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice

  During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).

Secondary Outcomes (5)

• Course of symptom relief

  During documentation of up to two short-term follow-up visits (within ca. 14 days)

• Speed of return to normal daily life activities

  During documentation of the last short-term follow-up visit (after ca. 14 days)

• Adverse events collection

  Throughout the entire study, whenever Adverse Events occur

• Evaluation of frequency of new exacerbations

  During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)

• Progression of chronic respiratory disease

  During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)

Study Arms (1)

Group 1

Drug: Moxifloxacin (Avelox, BAY12-8039)

Interventions

Moxifloxacin (Avelox, BAY12-8039) DRUG

AECB patients under daily life treatment receiving moxifloxacin according to the local product information.

Group 1

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of AECB who take moxifloxacin

You may qualify if:

• Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin

Sponsors & Collaborators

• Bayer: lead

Study Sites (24)

Unknown Facility

Many Locations, Austria

Location

Unknown Facility

Many Locations, Brazil

Location

Unknown Facility

Many Locations, China

Location

Unknown Facility

Many Locations, Colombia

Location

Unknown Facility

Many Locations, Croatia

Location

Unknown Facility

Many Locations, Egypt

Location

Unknown Facility

Many Locations, El Salvador

Location

Unknown Facility

Many Locations, Germany

Location

Unknown Facility

Many Locations, Hong Kong

Location

Unknown Facility

Many Locations, Hungary

Location

Unknown Facility

Many Locations, Indonesia

Location

Unknown Facility

Many Locations, Malaysia

Location

Unknown Facility

Many Locations, Mexico

Location

Unknown Facility

Many Locations, Morocco

Location

Unknown Facility

Many Locations, Netherlands

Location

Unknown Facility

Many Locations, Pakistan

Location

Unknown Facility

Many Locations, Philippines

Location

Unknown Facility

Many Locations, Poland

Location

Unknown Facility

Many Locations, Singapore

Location

Unknown Facility

Many Locations, Slovenia

Location

Unknown Facility

Many Locations, South Korea

Location

Unknown Facility

Many Locations, Switzerland

Location

Unknown Facility

Many Locations, Taiwan

Location

Unknown Facility

Many Locations, Turkey (Türkiye)

Location

Related Publications (1)

• Anzueto A, Miravitlles M, Ewig S, Legnani D, Heldner S, Stauch K. Identifying patients at risk of late recovery (>/= 8 days) from acute exacerbation of chronic bronchitis and COPD. Respir Med. 2012 Sep;106(9):1258-67. doi: 10.1016/j.rmed.2012.06.002. Epub 2012 Jun 30.

  PMID: 22749710 RESULT

MeSH Terms

Conditions

Bronchitis, Chronic; Bronchial Diseases

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 2, 2009
• First Posted: July 3, 2009
• Study Start: February 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

SL (1); EG (1); PA (1); HU (1); PL (1); SG (1); HK (1); DE (1); MY (1); BR (1); PH (1); MO (1); CH (1); EL (1); ME (1); ID (1); AU (1); KR (1); TW (1); CN (1); CR (1); TU (1); NL (1); CO (1)