Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-Abdominal Infection (cIAI)

This is a study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI. Subjects will be followed for efficacy through the test-of-cure assessment. Safety evaluations will occur through the treatment and post-treatment periods and continue through resolution or stability of the adverse event(s).

Official Title

A Multicenter, Open-Label, Randomized Comparative Study of Tigecycline vs Ceftriaxone Sodium Plus Metronidazole for the Treatment of Hospitalized Subjects With Complicated Intra-Abdominal Infection

Conditions

• Appendicitis
• Cholecystitis
• Diverticulitis
• Intra-Abdominal Abscess
• Intra-Abdominal Infection
• Peritonitis

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

• Clinical response in the clinically evaluable population at the Test-of-Cure visit.

Secondary Outcome Measures:

• To compare the microbiological efficacy of tigecycline to ceftriaxone plus metronidazole in the microbiologically evaluable population; To evaluate in vitro susceptibility data on tigecycline for a range of pathogenic bacteria that cause cIAI; To compare health care utilization between treatment groups

Study Start

October 2005; Expected completion: October 2007

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

Inclusion Criteria:

• Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
• Fever plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion Criteria:

• Cancer
• Medicines that suppress the immune system
• Dialysis

Total Enrolment

430

Contact Details

Australian Locations:

• Parkville, VIC 3050, Australia; Recruiting
• Cairns, QLD 4870, Australia; Recruiting
• Nambour, Queensland, 4560, Australia; Recruiting

Trial Manager: clintrialparticipation@wyeth.com