Clinical trial NCT00230971: Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Appendicitis
Cholecystitis
Diverticulitis
Intra-Abdominal Abscess
Intra-Abdominal Infection
Peritonitis
Keywords: Intra-Abdominal Infections
Abscess
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-03
Enrollment: 473
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Number of Clinically Evaluable (CE) Patients With Clinical Response of Cure at the Test-of-Cure (TOC) Visit
timeFrame: up to 6 weeks
Secondary outcomes:
measure: Number of Microbiologically Evaluable (ME) Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit
timeFrame: up to 6 weeks
measure: Number of Microbiologically Evaluable (ME) Patients by Microbiological Response at Test-of-Cure (TOC) Visit
timeFrame: up to 6 weeks
measure: Number of Days of Inpatient Healthcare Resource Utilization on or Before Test-of-Cure
timeFrame: up to 6 weeks
Other outcomes:
Locations:
city: Nambour
country: Australia
state: Queensland
city: Cairns
country: Australia
city: Parkville
country: Australia
city: Shanghai
country: China
city: Odense
country: Denmark
city: Lahti
country: Finland
city: Seinajoki
country: Finland
city: Tampere
country: Finland
city: Marseille
country: France
city: Nimes
country: France
city: Pierre Benite
country: France
city: Saint Denis
country: France
city: Bochum
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Heidelberg
country: Germany
city: Leipzig
country: Germany
city: Luebeck
country: Germany
city: Muenster
country: Germany
city: Tuebingen
country: Germany
city: Athens
country: Greece
city: Athens
country: Greece
city: Thessaloniki
country: Greece
city: New Territories
country: Hong Kong
city: Pokfulam
country: Hong Kong
city: Hyderabad
country: India
state: Andhra
city: Bhopal
country: India
city: Lucknow
country: India
city: Mumbai
country: India
city: New Delhi
country: India
city: Brescia
country: Italy
city: Genova
country: Italy
city: Pavia
country: Italy
city: Rome
country: Italy
city: Udine
country: Italy
city: Vicenza
country: Italy
city: Manila
country: Philippines
city: Quezon City
country: Philippines
city: Quezon City
country: Philippines
city: Almada
country: Portugal
city: Coimbra
country: Portugal
city: Porto
country: Portugal
city: Porto
country: Portugal
city: Riyadh
country: Saudi Arabia
city: Bellville
country: South Africa
city: Kuilsriver
country: South Africa
city: Parow
country: South Africa
city: Pietermaritzburg
country: South Africa
city: Pretoria
country: South Africa
city: Barcelona
country: Spain
city: Bilbao
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Bern
country: Switzerland
city: Geneva
country: Switzerland
city: Lugano
country: Switzerland
city: Zurich
country: Switzerland
city: Changhua
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Tao-yuan
country: Taiwan
city: Ankara
country: Turkey
city: Istanbul
country: Turkey
city: Stockport
country: United Kingdom
state: Cheshire
city: Birmingham
country: United Kingdom
city: Wigan
country: United Kingdom
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Australia, China, Hong Kong, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Taiwan, medinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Denmark, Finland, MedInfoNord@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Germany, MedinfoDEU@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For South Africa, ZAFinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Italy, Greece, decresg@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For UK, ukmedinfo@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Switzerland, med@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For France, infomedfrance@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Spain, infomed@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
affiliation: For Turkey, Erisc@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
citation: Qvist N, Warren B, Leister-Tebbe H, Zito ET, Pedersen R, McGovern PC, Babinchak T. Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: results from a randomized, controlled trial. Surg Infect (Larchmt). 2012 Apr;13(2):102-9. doi: 10.1089/sur.2011.048. Epub 2012 Mar 22.