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Greatest International Antiinfective Trial With Avelox

GIANT - Greatest International Antiinfective Trial With Avelox®

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00932802
Acronym
GIANT
Enrollment
50000
Registered
2009-07-03
Start date
2004-02-29
Completion date
2007-11-30
Last updated
2012-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchitis, Chronic, Bronchial Diseases

Keywords

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

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.

Interventions

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

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frame
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 practiceDuring 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

MeasureTime frame
Course of symptom reliefDuring documentation of up to two short-term follow-up visits (within ca. 14 days)
Speed of return to normal daily life activitiesDuring documentation of the last short-term follow-up visit (after ca. 14 days)
Adverse events collectionThroughout the entire study, whenever Adverse Events occur
Evaluation of frequency of new exacerbationsDuring documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
Progression of chronic respiratory diseaseDuring documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)

Countries

Austria, Brazil, China, Colombia, Croatia, Egypt, El Salvador, Germany, Hong Kong, Hungary, Indonesia, Malaysia, Mexico, Morocco, Netherlands, Pakistan, Philippines, Poland, Singapore, Slovenia, South Korea, Switzerland, Taiwan, Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026