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Completed

NCT Number: NCT00932802

Greatest International Antiinfective Trial With Avelox

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.

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Exclusion criteria must be read in conjunction with the local product information

Treatment and study plan

Moxifloxacin (Avelox, BAY12-8039)

Drug

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

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

    Time frame: 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

  1. Course of symptom relief

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

  2. Speed of return to normal daily life activities

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

  3. Adverse events collection

    Time frame: Throughout the entire study, whenever Adverse Events occur

  4. Evaluation of frequency of new exacerbations

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

  5. Progression of chronic respiratory disease

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

GIANT - Greatest International Antiinfective Trial With Avelox®

Acronym: GIANT

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Jul 3, 2009
Registry last updated
Nov 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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