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

NCT ID: NCT00952796

Last Updated: 2011-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Intra-abdominal Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1

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

Group Type EXPERIMENTAL

moxifloxacin

Intervention Type DRUG

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

2

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

Group Type ACTIVE_COMPARATOR

ampicillin/sulbactam

Intervention Type DRUG

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

Interventions

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moxifloxacin

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

Intervention Type DRUG

ampicillin/sulbactam

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

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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kaohsiung medical university hospital

Locations

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Kaohsiung Medical University Hospital, Department of Emergency Medicine/Surgery

Kaohsiung, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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KMU-IRB-970389

Identifier Type: -

Identifier Source: org_study_id

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