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

August 1, 2011 updated by: Kaohsiung Medical University Chung-Ho Memorial Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Kaohsiung, Taiwan, 804
        • Kaohsiung Medical University Hospital, Department of Emergency Medicine/Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
patients with intra-abdominal infection treated with moxifloxacin 400mg once daily
Drug: moxifloxacin
moxifloxacin 400mg once daily (IV form, 60minutes)
Active Comparator: 2
patients with intra-abdominal infection treated with ampicillin/sulbactam 1.5g 4 times daily
Drug: ampicillin/sulbactam
ampicillin/sulbactam 1.5g 4 times daily (IV form, administered 60minutes)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
clinical response at test-of-cure visit
Time Frame: test of cure: 10-14 days after initial treatment
test of cure: 10-14 days after initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 1, 2009

First Submitted That Met QC Criteria

August 4, 2009

First Posted (Estimate)

August 6, 2009

Study Record Updates

Last Update Posted (Estimate)

August 2, 2011

Last Update Submitted That Met QC Criteria

August 1, 2011

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMU-IRB-970389

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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