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

This study has been completed.
Sponsor:
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00952796
First received: March 1, 2009
Last updated: August 1, 2011
Last verified: January 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Intra-abdominal Infection
 Drug: moxifloxacin
Drug: ampicillin/sulbactam
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Comparative Study of Ampicillin/Sulbactam Versus Moxifloxacin in the Treatment of Complicated Intra-abdominal Infections

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:

Primary Outcome Measures:
  • clinical response at test-of-cure visit [ Time Frame: test of cure: 10-14 days after initial treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952796

Locations
Taiwan
Kaohsiung Medical University Hospital, Department of Emergency Medicine/Surgery
Kaohsiung, Taiwan, 804
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
  More Information

No publications provided

Responsible Party: Trauma Service Office, kaohsiung medical university hospital
ClinicalTrials.gov Identifier: NCT00952796     History of Changes
Other Study ID Numbers: KMU-IRB-970389
Study First Received: March 1, 2009
Last Updated: August 1, 2011
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
intra-abdominal infection
moxifloxacin
ampicillin/sulbactam

Additional relevant MeSH terms:
Ampicillin
Sulbactam
Sultamicillin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013