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Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01670435
First received: August 7, 2012
Last updated: August 27, 2012
Last verified: August 2012
  Purpose

This study is a post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Ciproxan intravenously as a first-line treatment for sepsis, secondary skin infections followed by superficial burn, post-surgical or post-traumatic, pneumonia, peritonitis, cholecystitis, cholangitis, anthrax. The objective of this study is to assess safety and efficacy of Ciproxan in daily clinical practice. A total of 3,000 patients are to be enrolled and assessed during the period of treatment with Ciproxan.


Condition Intervention
Infection
Drug: Ciprofloxacin (BAYQ3939)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Assessment of the Safety and Efficacy of Ciproxan-I.V. in Daily Clinical Practice - Analysis Results From a Post-marketing Surveillance

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of adverse drug reactions (ADRs) and serious adverse events (AEs) [ Time Frame: After 9 days ] [ Designated as safety issue: Yes ]
  • Clinical efficacy by four grade (Response, Minor Response, No Response, and Indeterminable) at an investigator discretion [ Time Frame: After 9 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADR incidence rates classified by patient's background factors [ Time Frame: After 9 days ] [ Designated as safety issue: Yes ]
  • Efficacy rate calculated with Response and Minor Response considered as responder [ Time Frame: After 9 days ] [ Designated as safety issue: No ]
  • Efficacy rates classified by patient's background factors [ Time Frame: After 9 days ] [ Designated as safety issue: No ]

Enrollment: 3274
Study Start Date: May 2007
Study Completion Date: October 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Ciprofloxacin (BAYQ3939)
Patient treated with Ciproxan as a first line treatment in daily clinical practice

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who received Ciproxan as a first-line treatment were eligible for the study, among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.

Criteria

Inclusion Criteria:

  • Patients who received Ciproxan as a first-line treatment were eligible for the study, among those with sepsis, secondary infection due to trauma, burn, or surgical wound, pneumonia, peritonitis, cholecystitis, cholangitis, and anthrax as the indications of this drug.

Exclusion Criteria:

  • Patients who are contraindicated based on the product label.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670435

Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT01670435     History of Changes
Other Study ID Numbers: 15029, CIPRO-IV-2007
Study First Received: August 7, 2012
Last Updated: August 27, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Ciprofloxacin
sepsis
infection
pneumonia
peritonitis
cholecystitis
cholangitis
anthrax

Additional relevant MeSH terms:
Infection
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014