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: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
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

Overall contact:
Trial Manager, Email: clintrialparticipation@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: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: Clinical response in the clinically evaluable population at the Test-of-Cure visit.

Secondary outcome:

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

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

Trial Manager, Email: clintrialparticipation@wyeth.com

Parkville VIC 3050, Australia; Recruiting

Cairns QLD 4870, Australia; Recruiting

Shanghai 200032, China; Not yet recruiting

Odense 5000, Denmark; Recruiting

Lahti 15850, Finland; Not yet recruiting

Tampere 33101, Finland; Not yet recruiting

Seinajoki 60220, Finland; Recruiting

Nimes 30 029, France; Not yet recruiting

Marseille 13 009, France; Not yet recruiting

Saint Denis 93205, France; Not yet recruiting

Pierre Benite 69495, France; Not yet recruiting

Tuebingen 72056, Germany; Recruiting

Frankfurt 60590, Germany; Recruiting

Leipzig 04129, Germany; Recruiting

Heidelberg 69120, Germany; Recruiting

Freiburg 79106, Germany; Recruiting

Bochum 44791, Germany; Recruiting

Luebeck 23538, Germany; Not yet recruiting

Muenster 48149, Germany; Not yet recruiting

Thessaloniki 54623, Greece; Recruiting

Athens 11527, Greece; Recruiting

Athens 12462, Greece; Recruiting

New Territories, Hong Kong; Recruiting

Pokfulam, Hong Kong; Recruiting

Lucknow 226 014, India; Recruiting

Bhopal 462 038, India; Recruiting

Mumbai 400071, India; Recruiting

New Delhi 110060, India; Recruiting

Rome 00168, Italy; Not yet recruiting

Udine 33100, Italy; Not yet recruiting

Brescia 25123, Italy; Recruiting

Genova 16132, Italy; Recruiting

Vicenza 36100, Italy; Not yet recruiting

Pavia 27100, Italy; Not yet recruiting

Quezon City 1100, Philippines; Recruiting

Manila 1000, Philippines; Recruiting

Quezon City 1105, Philippines; Recruiting

Porto 4099-100, Portugal; Not yet recruiting

Porto 4200-319, Portugal; Not yet recruiting

Coimbra 3000-075, Portugal; Not yet recruiting

Almada 2801-951, Portugal; Not yet recruiting

Riyadh, Saudi Arabia; Not yet recruiting

Parow 7505, South Africa; Recruiting

Pietermaritzburg 3201, South Africa; Recruiting

Kuilsriver 7580, South Africa; Not yet recruiting

Pretoria 001, South Africa; Recruiting

Bellville 7530, South Africa; Recruiting

Barcelona 08003, Spain; Recruiting

Madrid 28040, Spain; Recruiting

Madrid 28905, Spain; Not yet recruiting

Murcia 30120, Spain; Not yet recruiting

Bilbao 48903, Spain; Not yet recruiting

Zurich 8091, Switzerland; Not yet recruiting

Geneva 1211, Switzerland; Recruiting

Bern 3010, Switzerland; Recruiting

Lugano 6900, Switzerland; Recruiting

Taipei 100, Taiwan; Recruiting

Tao-yuan 333, Taiwan; Recruiting

Tainan, Taiwan; Recruiting

Taichung 404, Taiwan; Recruiting

Changhua 500, Taiwan; Recruiting

Ankara 06100, Turkey; Recruiting

Istanbul 34718, Turkey; Not yet recruiting

Wigan WN1 2NN, United Kingdom; Not yet recruiting

Birmingham B9 5SS, United Kingdom; Recruiting

Hyderabad, Andhra 500 082, India; Recruiting

Stockport, Cheshire SK2 7JE, United Kingdom; Recruiting

Nambour, Queensland 4560, Australia; Recruiting

Starting date: October 2005
Ending date: September 2008
Last updated: December 19, 2007