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

Condition(s) targeted: Appendicitis; Cholecystitis; Diverticulitis; Intra-Abdominal Abscess; Intra-Abdominal Infection; Peritonitis

Intervention: tigecycline (Drug); ceftriaxone plus metronidazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Wyeth is now a wholly owned subsidiary of Pfizer

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
Trial Manager, Principal Investigator, Affiliation: For Australia, China, Hong Kong, medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Taiwan, medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Denmark, Finland, MedInfoNord@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Germany, MedinfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For South Africa, ZAFinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Italy, Greece, decresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For UK, ukmedinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Switzerland, med@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For France, infomedfrance@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Spain, infomed@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Turkey, Erisc@wyeth.com

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit

Secondary outcome:

Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit

Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit

Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Cairns QLD 4870, Australia

Parkville VIC 3050, Australia

Shanghai 200032, China

Odense 5000, Denmark

Lahti 15850, Finland

Seinajoki 60220, Finland

Tampere 33101, Finland

Marseille 13 009, France

Nimes 30 029, France

Pierre Benite 69495, France

Saint Denis 93205, France

Bochum 44791, Germany

Frankfurt 60590, Germany

Freiburg 79106, Germany

Heidelberg 69120, Germany

Leipzig 04129, Germany

Luebeck 23538, Germany

Muenster 48149, Germany

Tuebingen 72056, Germany

Athens 11527, Greece

Athens 12462, Greece

Thessaloniki 54623, Greece

New Territories, Hong Kong

Pokfulam, Hong Kong

Bhopal 462 038, India

Lucknow 226 014, India

Mumbai 400071, India

New Delhi 110060, India

Brescia 25123, Italy

Genova 16132, Italy

Pavia 27100, Italy

Rome 00168, Italy

Udine 33100, Italy

Vicenza 36100, Italy

Manila 1000, Philippines

Quezon City 1100, Philippines

Quezon City 1105, Philippines

Almada 2801-951, Portugal

Coimbra 3000-075, Portugal

Porto 4200-319, Portugal

Porto 4099-100, Portugal

Riyadh, Saudi Arabia

Bellville 7530, South Africa

Kuilsriver 7580, South Africa

Parow 7505, South Africa

Pietermaritzburg 3201, South Africa

Pretoria 001, South Africa

Barcelona 08003, Spain

Bilbao 48903, Spain

Madrid 28040, Spain

Madrid 28905, Spain

Murcia 30120, Spain

Bern 3010, Switzerland

Geneva 1211, Switzerland

Lugano 6900, Switzerland

Zurich 8091, Switzerland

Changhua 500, Taiwan

Taichung 404, Taiwan

Tainan, Taiwan

Taipei 100, Taiwan

Tao-yuan 333, Taiwan

Ankara 06100, Turkey

Istanbul 34718, Turkey

Birmingham B9 5SS, United Kingdom

Wigan WN1 2NN, United Kingdom

Hyderabad, Andhra 500 082, India

Stockport, Cheshire SK2 7JE, United Kingdom

Nambour, Queensland 4560, Australia

Starting date: October 2005
Last updated: February 20, 2013