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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:
ClinicalTrials.gov Identifier:
NCT00952796
First Posted: August 6, 2009
Last Update Posted: August 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Kaohsiung Medical University Chung-Ho Memorial Hospital
  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
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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:


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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Trauma Service Office, kaohsiung medical university hospital
ClinicalTrials.gov Identifier: NCT00952796     History of Changes
Other Study ID Numbers: KMU-IRB-970389
First Submitted: March 1, 2009
First Posted: August 6, 2009
Last Update Posted: August 2, 2011
Last Verified: January 2009

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

Additional relevant MeSH terms:
Infection
Communicable Diseases
Intraabdominal Infections
Moxifloxacin
Fluoroquinolones
Ampicillin
Sulbactam
Sultamicillin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors
beta-Lactamase Inhibitors


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