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

Primary Purpose

Intra-abdominal Infection

Status

Completed

Phase

Phase 4

Locations

Taiwan

Study Type

Interventional

Intervention

moxifloxacin

ampicillin/sulbactam

About this trial

This is an interventional treatment trial for Intra-abdominal Infection focused on measuring intra-abdominal infection, moxifloxacin, ampicillin/sulbactam

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Kaohsiung Medical University Hospital, Department of Emergency Medicine/Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

patients with intra-abdominal infection treated with moxifloxacin 400mg once daily

patients with intra-abdominal infection treated with ampicillin/sulbactam 1.5g 4 times daily

Outcomes

Primary Outcome Measures

clinical response at test-of-cure visit

Secondary Outcome Measures

Full Information

NCT ID

NCT00952796

First Posted

March 1, 2009

Last Updated

August 1, 2011

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00952796

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intra-abdominal Infection

Keywords

intra-abdominal infection, moxifloxacin, ampicillin/sulbactam

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

patients with intra-abdominal infection treated with moxifloxacin 400mg once daily

Arm Title

Arm Type

Active Comparator

Arm Description

patients with intra-abdominal infection treated with ampicillin/sulbactam 1.5g 4 times daily

Intervention Type

Drug

Intervention Name(s)

moxifloxacin

Intervention Description

moxifloxacin 400mg once daily (IV form, 60minutes)

Intervention Type

Drug

Intervention Name(s)

ampicillin/sulbactam

Intervention Description

ampicillin/sulbactam 1.5g 4 times daily (IV form, administered 60minutes)

Primary Outcome Measure Information:

Title

clinical response at test-of-cure visit

Time Frame

test of cure: 10-14 days after initial treatment

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Kaohsiung Medical University Hospital, Department of Emergency Medicine/Surgery

City

Kaohsiung

ZIP/Postal Code

804

Country

Taiwan

12. IPD Sharing Statement

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

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