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

Phase 4

Completed

• Conditions: Intra-abdominal Infection
• Interventions: Drug: ampicillin/sulbactam; Drug: moxifloxacin

• Registration Number: NCT00952796
• Lead Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital

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 available

Study Timeline

• Status Verified: 2009-01
• Study Start: 2009-01
• Study First Submitted: 2009-03-01
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Last Update Submitted: 2011-08-01
• Last Update Posted: 2011-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	ampicillin/sulbactam	patients with intra-abdominal infection treated with ampicillin/sulbactam 1.5g 4 times daily
1	moxifloxacin	patients with intra-abdominal infection treated with moxifloxacin 400mg once daily

Primary Outcome Measures

Name	Time	Method
clinical response at test-of-cure visit	test of cure: 10-14 days after initial treatment

Trial Locations

Locations (1)

Kaohsiung Medical University Hospital, Department of Emergency Medicine/Surgery; 🇨🇳 Kaohsiung, Taiwan