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

Intra-abdominal Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00952796
• Other study ID #: KMU-IRB-970389
• Status: Completed
• Phase: Phase 4
• First received: March 1, 2009
• Last updated: August 1, 2011
• Start date: January 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2009
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Intra-abdominal Infection
• Intraabdominal Infections

Intervention

Drug:
• moxifloxacin
moxifloxacin 400mg once daily (IV form, 60minutes)
• ampicillin/sulbactam
ampicillin/sulbactam 1.5g 4 times daily (IV form, administered 60minutes)

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital, Department of Emergency Medicine/Surgery	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical response at test-of-cure visit		test of cure: 10-14 days after initial treatment	Yes