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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 1, 2009
Last Updated Date	August 1, 2011
Start Date ^ICMJE	January 2009
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 4, 2009)	clinical response at test-of-cure visit [ Time Frame: test of cure: 10-14 days after initial treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00952796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections
Official Title ^ICMJE	A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Intra-abdominal Infection
Intervention ^ICMJE	Drug: moxifloxacin moxifloxacin 400mg once daily (IV form, 60minutes) Drug: ampicillin/sulbactam ampicillin/sulbactam 1.5g 4 times daily (IV form, administered 60minutes)
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	100
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Taiwan

Administrative Information
NCT Number ^ICMJE	NCT00952796
Other Study ID Numbers ^ICMJE	KMU-IRB-970389
Has Data Monitoring Committee	Not Provided
Responsible Party	Trauma Service Office, kaohsiung medical university hospital
Study Sponsor ^ICMJE	Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Kaohsiung Medical University Chung-Ho Memorial Hospital
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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