A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections

This study has been completed.
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00952796
First received: March 1, 2009
Last updated: August 1, 2011
Last verified: January 2009

March 1, 2009
August 1, 2011
January 2009
December 2010   (final data collection date for primary outcome measure)
clinical response at test-of-cure visit [ Time Frame: test of cure: 10-14 days after initial treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00952796 on ClinicalTrials.gov Archive Site
Not Provided
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A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections
A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections

On the basis of monotherapy for intra-abdominal infection, the investigators are conducting this study to identify the difference of drug efficacy between ampicillin/sulbactam and moxifloxacin.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Intra-abdominal Infection
  • Drug: moxifloxacin
    moxifloxacin 400mg once daily (IV form, 60minutes)
  • Drug: ampicillin/sulbactam
    ampicillin/sulbactam 1.5g 4 times daily (IV form, administered 60minutes)
  • Experimental: 1
    patients with intra-abdominal infection treated with moxifloxacin 400mg once daily
    Intervention: Drug: moxifloxacin
  • Active Comparator: 2
    patients with intra-abdominal infection treated with ampicillin/sulbactam 1.5g 4 times daily
    Intervention: Drug: ampicillin/sulbactam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients diagnosed of complicated intra-abdominal infection need surgical treatment

Exclusion Criteria:

  • patients diagnosed of intra-abdominal infection receive non-operative management
  • patients with known allergic history of fluoroquinolone
  • Severe, life threatening disease with a life expectancy of < 48 h or APS and APACHE scores of > 35
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00952796
KMU-IRB-970389
Not Provided
Trauma Service Office, kaohsiung medical university hospital
Kaohsiung Medical University Chung-Ho Memorial Hospital
Not Provided
Not Provided
Kaohsiung Medical University Chung-Ho Memorial Hospital
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP