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

NCT00230971 | Completed Phase 4 Results

• 1 other identifier: 3074A1-315
• Study Type: interventional
• Target: 473
• Locations: 19 countries
• Sites: 68

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).

Conditions

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

Keywords

Intra-Abdominal Infections; Abscess

Outcome Measures

Primary Outcomes (1)

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

  CE population were those who completed TOC assessment of cure or failure (but not indeterminate) or, in case of premature discontinuation due to lack of efficacy, had completed end of treatment assessment such that assessment of clinical response could be made. Clinical response was assigned by investigator per protocol-specified guidelines and defined as: test article and initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. TOC performed 10-28 days after last dose of study drug.

  up to 6 weeks

Secondary Outcomes (3)

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

  up to 6 weeks

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

  up to 6 weeks

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

  up to 6 weeks

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: tigecycline

B

ACTIVE COMPARATOR

Drug: ceftriaxone plus metronidazole

Interventions

tigecycline DRUG

every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)

A

ceftriaxone plus metronidazole DRUG

Ceftriaxone sodium 2 g once daily intravenously plus metronidazole 1 g to 2 g daily given in divided doses intravenously. Test article should be administered for a minimum of 4 days and up to 14 days at the discretion of the investigator.

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cancer
• Medicines that suppress the immune system
• Dialysis

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (68)

Unknown Facility

Nambour, Queensland, 4560, Australia

Location

Unknown Facility

Cairns, QLD 4870, Australia

Location

Unknown Facility

Parkville, VIC 3050, Australia

Location

Unknown Facility

Shanghai, 200032, China

Location

Unknown Facility

Odense, 5000, Denmark

Location

Unknown Facility

Lahti, 15850, Finland

Location

Unknown Facility

Seinäjoki, 60220, Finland

Location

Unknown Facility

Tampere, 33101, Finland

Location

Unknown Facility

Marseille, 13 009, France

Location

Unknown Facility

Nîmes, 30 029, France

Location

Unknown Facility

Pierre-Bénite, 69495, France

Location

Unknown Facility

Saint-Denis, 93205, France

Location

Unknown Facility

Bochum, 44791, Germany

Location

Unknown Facility

Frankfurt, 60590, Germany

Location

Unknown Facility

Freiburg im Breisgau, 79106, Germany

Location

Unknown Facility

Heidelberg, 69120, Germany

Location

Unknown Facility

Leipzig, 04129, Germany

Location

Unknown Facility

Lübeck, 23538, Germany

Location

Unknown Facility

Münster, 48149, Germany

Location

Unknown Facility

Tübingen, 72056, Germany

Location

Unknown Facility

Athens, 11527, Greece

Location

Unknown Facility

Athens, 12462, Greece

Location

Unknown Facility

Thessaloniki, 54623, Greece

Location

Unknown Facility

New Territories, Hong Kong

Location

Unknown Facility

Pokfulam, Hong Kong

Location

Unknown Facility

Hyderabad, Telangana, 500 082, India

Location

Unknown Facility

Bhopal, 462 038, India

Location

Unknown Facility

Lucknow, 226 014, India

Location

Unknown Facility

Mumbai, 400071, India

Location

Unknown Facility

New Delhi, 110060, India

Location

Unknown Facility

Brescia, 25123, Italy

Location

Unknown Facility

Genova, 16132, Italy

Location

Unknown Facility

Pavia, 27100, Italy

Location

Unknown Facility

Rome, 00168, Italy

Location

Unknown Facility

Udine, 33100, Italy

Location

Unknown Facility

Vicenza, 36100, Italy

Location

Unknown Facility

Manila, 1000, Philippines

Location

Unknown Facility

Quezon City, 1100, Philippines

Location

Unknown Facility

Quezon City, 1105, Philippines

Location

Unknown Facility

Almada, 2801-951, Portugal

Location

Unknown Facility

Coimbra, 3000-075, Portugal

Location

Unknown Facility

Porto, 4099-100, Portugal

Location

Unknown Facility

Porto, 4200-319, Portugal

Location

Unknown Facility

Riyadh, Saudi Arabia

Location

Unknown Facility

Bellville, 7530, South Africa

Location

Unknown Facility

Kuilsriver, 7580, South Africa

Location

Unknown Facility

Parow, 7505, South Africa

Location

Unknown Facility

Pietermaritzburg, 3201, South Africa

Location

Unknown Facility

Pretoria, 001, South Africa

Location

Unknown Facility

Barcelona, 08003, Spain

Location

Unknown Facility

Bilbao, 48903, Spain

Location

Unknown Facility

Madrid, 28040, Spain

Location

Unknown Facility

Madrid, 28905, Spain

Location

Unknown Facility

Murcia, 30120, Spain

Location

Unknown Facility

Bern, 3010, Switzerland

Location

Unknown Facility

Geneva, 1211, Switzerland

Location

Unknown Facility

Lugano, 6900, Switzerland

Location

Unknown Facility

Zurich, 8091, Switzerland

Location

Unknown Facility

Changhua, 500, Taiwan

Location

Unknown Facility

Taichung, 404, Taiwan

Location

Unknown Facility

Tainan, Taiwan

Location

Unknown Facility

Taipei, 100, Taiwan

Location

Unknown Facility

Taoyuan District, 333, Taiwan

Location

Unknown Facility

Ankara, 06100, Turkey (Türkiye)

Location

Unknown Facility

Istanbul, 34718, Turkey (Türkiye)

Location

Unknown Facility

Stockport, Cheshire, SK2 7JE, United Kingdom

Location

Unknown Facility

Birmingham, B9 5SS, United Kingdom

Location

Unknown Facility

Wigan, WN1 2NN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22439781 DERIVED

MeSH Terms

Conditions

Appendicitis; Cholecystitis; Diverticulitis; Abdominal Abscess; Intraabdominal Infections; Peritonitis; Abscess

Interventions

Tigecycline; Ceftriaxone; Metronidazole

Condition Hierarchy (Ancestors)

Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Gallbladder Diseases; Biliary Tract Diseases; Diverticular Diseases; Suppuration; Peritoneal Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Australia, China, Hong Kong, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Taiwan, medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Denmark, Finland, MedInfoNord@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Germany, MedinfoDEU@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For South Africa, ZAFinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Italy, Greece, decresg@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For UK, ukmedinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Switzerland, med@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For France, infomedfrance@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Spain, infomed@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Turkey, Erisc@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 3, 2005
• Study Start: October 1, 2005
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: February 25, 2013
• Results First Posted: April 26, 2010

Record last verified: 2013-02

Locations

AU (3); HK (2); ZA (5); CH (4); DE (8); FR (4); CN (1); PT (4); SA (1); GR (3); PH (3); ES (5); IN (5); TU (2); FI (3); TW (5); IT (6); DK (1); GB (3)