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

Kaohsiung Medical University

Status and phase: Completed; Phase 4

Conditions: Intra-abdominal Infection

Treatments: Drug: ampicillin/sulbactam; Drug: moxifloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT00952796

KMU-IRB-970389

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: moxifloxacin

2

Active Comparator group

Description:

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

Treatment:

Drug: ampicillin/sulbactam