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Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

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Wyeth

Status and phase

Completed
Phase 4

Conditions

Cross Infection
Cholecystitis
Appendicitis
Peritonitis
Diverticulitis

Treatments

Drug: tigecycline
Drug: ceftriaxone sodium + metronidazole

Study type

Interventional

Funder types

Industry

Identifiers

NCT00195351
3074A1-400

Details and patient eligibility

About

This is a phase 3b/4 randomized, open-label, comparative, multicenter study of the safety and efficacy of tigecycline to ceftriaxone sodium plus metronidazole in hospitalized subjects with cIAI (Complicated Intra-Abdominal Infection). Subjects with clinical signs and symptoms of cIAI will be included for enrollment. Subjects will be stratified at randomization for Acute Physiologic and Chronic Health Evaluation scale (APACHE II) score < 10 and > 10. 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).

Enrollment

467 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of complicated intra-abdominal infection that requires surgery within 24 hours.
  • Fever over 100.4°F (38.0°C) or high white blood cell count plus other symptoms such as nausea, vomiting, abdominal pain.

Exclusion criteria

  • Cancer
  • Medicines that suppress the immune system
  • Dialysis

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

467 participants in 2 patient groups

A
Active Comparator group
Treatment:
Drug: tigecycline
B
Active Comparator group
Treatment:
Drug: ceftriaxone sodium + metronidazole

Trial contacts and locations

66

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Data sourced from clinicaltrials.gov

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