NCT00952796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2009

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

August 2, 2011

Status Verified

January 1, 2009

Enrollment Period

1.9 years

First QC Date

March 1, 2009

Last Update Submit

August 1, 2011

Conditions

Intra-abdominal Infection

Keywords

intra-abdominal infectionmoxifloxacinampicillin/sulbactam

Outcome Measures

Primary Outcomes (1)

  • clinical response at test-of-cure visit

    test of cure: 10-14 days after initial treatment

Study Arms (2)

1

EXPERIMENTAL

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

Drug: moxifloxacin

2

ACTIVE COMPARATOR

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

Drug: ampicillin/sulbactam

Interventions

moxifloxacinDRUG

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

1
ampicillin/sulbactamDRUG

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

2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosed of complicated intra-abdominal infection need surgical treatment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Medical University Hospital, Department of Emergency Medicine/Surgery

Kaohsiung, Taiwan, 804, Taiwan

Location

MeSH Terms

Conditions

Intraabdominal Infections

Interventions

Moxifloxacinsultamicillin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 1, 2009

First Posted

August 6, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 2, 2011

Record last verified: 2009-01

Locations

TW(1)