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Completed

NCT Number: NCT01096511

Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)

This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from a cIAI and take at least one dose of Moxifloxacin infusion.The primary objective is to define the types of cIAI infections that require Moxifloxacin i.v. therapy in China.

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Key information

Conditions

Secondary Peritonitis Abdominal Abscess Abscess Abscess, Intra-Abdominal Digestive System Diseases Infections Intraabdominal Infections Peritoneal Diseases Peritonitis Suppuration

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients at least 18 years of age with a diagnosis of cIAI treated with Moxifloxacin infusion with/without sequential tablet treatment can be included into the study. The local Moxifloxacin product information must be considered.

Exclusion criteria

  • Contraindications stated in the local Moxifloxacin product information. Warnings and precautions, stated in the local Moxifloxacin product information must be considered as potential exclusion criteria.

Treatment and study plan

Moxifloxacin (Avelox, BAY12-8039)

Drug

The treatment with Moxifloxacin 400 mg infusion should comply with the recommendations written in the local product information. The decision about the treatment with Moxifloxacin as well as the duration of treatment is solely up to the attending physician.

Primary outcomes

  1. Types of cIAI infections

    Time frame: Day 1

Secondary outcomes

  1. Cure rate

    Time frame: 5-14 days

  2. Clinical signs and symptoms

    Time frame: 5-14 days

  3. Duration until improvement and cure

    Time frame: 5-14 days

  4. Adverse event collection

    Time frame: 5-14 days

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Clinical Effectiveness and Safety Study of Moxifloxacin i.v. in the Treatment of Complicated Intra-Abdominal Infection (cIAI)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2010
Registry last updated
Jun 21, 2013

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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