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Trial record 27 of 637 for:    Russian Federation | Chile

Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.

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ClinicalTrials.gov Identifier: NCT00366249
Recruitment Status : Completed
First Posted : August 21, 2006
Results First Posted : August 21, 2009
Last Update Posted : April 28, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Bacterial Infections
Diabetic Foot
Osteomyelitis
Interventions Drug: Tigecycline
Drug: Ertapenem
Enrollment 1061
Recruitment Details Patients were recruited worldwide from January 2007 to February 2009.
Pre-assignment Details Patients were screened for up to 24 hours.
Arm/Group Title Tigecycline Ertapenem
Hide Arm/Group Description Tigecycline 150 mg IV infusion every 24 hours Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
Period Title: Overall Study
Started 553 508
Completed 422 430
Not Completed 131 78
Reason Not Completed
Adverse Event             53             28
Death             0             1
Physician Decision             5             2
Lost to Follow-up             2             0
Protocol Violation             1             2
Withdrawal by Subject             18             4
Lack of Efficacy             21             21
Most due to osteomylitis status             31             20
Arm/Group Title Tigecycline Ertapenem Total
Hide Arm/Group Description Tigecycline 150 mg IV infusion every 24 hours Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage). Total of all reporting groups
Overall Number of Baseline Participants 553 508 1061
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 553 participants 508 participants 1061 participants
59.36  (12.04) 58.75  (11.70) 59.07  (11.88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 553 participants 508 participants 1061 participants
Female
199
  36.0%
165
  32.5%
364
  34.3%
Male
354
  64.0%
343
  67.5%
697
  65.7%
1.Primary Outcome
Title Number of Patients With Clinical Response of Cure Vs. Failure.
Hide Description Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to Diabetic Foot Infections (DFI) > 48 hrs.
Time Frame Test of cure visit (TOC): Assessed at least 12 days post last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Clinically evaluable population without osteomyelitis.
Arm/Group Title Tigecycline Ertapenem
Hide Arm/Group Description:
Tigecycline 150 mg IV infusion every 24 hours
Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
Overall Number of Participants Analyzed 408 405
Measure Type: Number
Unit of Measure: patients
Cure 316 334
Failure 92 71
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tigecycline, Ertapenem
Comments Analysis provided for Cure
Type of Statistical Test Non-Inferiority or Equivalence
Comments Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.
Method of Estimation Estimation Parameter Mehrotra and Railker
Estimated Value -5.5
Confidence Interval 95%
-11.0 to 0.1
Estimation Comments Adjusted for Perfusion, Extent, Depth/tissue loss, Infection, and Sensation (PEDIS) score
2.Primary Outcome
Title Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.
Hide Description Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.
Time Frame Test of cure visit (TOC): Assessed at least 12 days post last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical modified intent to treat population without osteomyelitis.
Arm/Group Title Tigecycline Ertapenem
Hide Arm/Group Description:
Tigecycline 150 mg IV infusion every 24 hours
Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
Overall Number of Participants Analyzed 476 466
Measure Type: Number
Unit of Measure: patients
Cure 340 363
Failure 117 86
Indeterminate 19 17
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tigecycline, Ertapenem
Comments Analysis provided for Cure
Type of Statistical Test Non-Inferiority or Equivalence
Comments Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.
Method of Estimation Estimation Parameter Mehrotra and Railkar
Estimated Value -6.7
Confidence Interval 95%
-12.3 to -1.1
Estimation Comments Adjusted for PEDIS score
3.Secondary Outcome
Title Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.
Hide Description Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs.
Time Frame Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Clinically evaluable population with osteomyelitis.
Arm/Group Title Tigecycline Ertapenem
Hide Arm/Group Description:
Tigecycline 150 mg IV infusion every 24 hours
Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
Overall Number of Participants Analyzed 38 24
Measure Type: Number
Unit of Measure: patients
Cure 12 13
Failure 26 11
4.Secondary Outcome
Title Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.
Hide Description Cure: Recovery so no added antibiotic therapy. Failure: Added antibiotic therapy for no response or worsening after improvement, new purulence, >120% doses, non-routine surgical treatment or death related to DFI > 48 hrs. Indeterminate: Lost to follow-up, death<48 hours or noninfection related.
Time Frame Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Clinical modified intent to treat population with osteomyelitis.
Arm/Group Title Tigecycline Ertapenem
Hide Arm/Group Description:
Tigecycline 150 mg IV infusion every 24 hours
Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
Overall Number of Participants Analyzed 53 33
Measure Type: Number
Unit of Measure: patients
Cure 19 21
Failure 27 12
Indeterminate 7 0
5.Secondary Outcome
Title Number of Patients With Microbiologic Response of Eradication.
Hide Description Eradication defined as: no pathogen is present in the repeat culture from the original site of infection, or a clinical response of the cure precludes the availability of a specimen for culture.
Time Frame Test of cure visit (TOC): Assessed at least 12 days post last dose
Hide Outcome Measure Data
Hide Analysis Population Description
Microbiologically evaluable population without osteomyelitis.
Arm/Group Title Tigecycline Ertapenem
Hide Arm/Group Description:
Tigecycline 150 mg IV infusion every 24 hours
Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
Overall Number of Participants Analyzed 316 317
Measure Type: Number
Unit of Measure: patients
209 229
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tigecycline, Ertapenem
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.
Method of Estimation Estimation Parameter Mehrotra and Railkar
Estimated Value -6.3
Confidence Interval 95%
-13.6 to 1.0
Estimation Comments Adjusted for PEDIS score
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tigecycline Ertapenem
Hide Arm/Group Description Tigecycline 150 mg IV infusion every 24 hours Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
All-Cause Mortality
Tigecycline Ertapenem
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tigecycline Ertapenem
Affected / at Risk (%) Affected / at Risk (%)
Total   79   62 
Blood and lymphatic system disorders     
Leukocytosis *  1/553 (0.18%)  0/508 (0.00%) 
Neutropenia *  0/553 (0.00%)  1/508 (0.20%) 
Cardiac disorders     
Atrial fibrillation *  2/553 (0.36%)  0/508 (0.00%) 
Bundle branch block *  0/553 (0.00%)  1/508 (0.20%) 
Cardiomegaly *  0/553 (0.00%)  1/508 (0.20%) 
Cerebral ischemia *  1/553 (0.18%)  0/508 (0.00%) 
Cerebrovascular accident *  0/553 (0.00%)  2/508 (0.39%) 
Congestive heart failure *  1/553 (0.18%)  2/508 (0.39%) 
Coronary artery disorder *  1/553 (0.18%)  0/508 (0.00%) 
Heart arrest *  1/553 (0.18%)  0/508 (0.00%) 
Heart failure *  0/553 (0.00%)  1/508 (0.20%) 
Myocardial infarct *  4/553 (0.72%)  0/508 (0.00%) 
Occlusion *  1/553 (0.18%)  2/508 (0.39%) 
Shock *  2/553 (0.36%)  0/508 (0.00%) 
Syncope *  1/553 (0.18%)  2/508 (0.39%) 
Tachycardia *  1/553 (0.18%)  0/508 (0.00%) 
Left heart failure *  2/553 (0.36%)  0/508 (0.00%) 
Gastrointestinal disorders     
Cholelithiasis *  1/553 (0.18%)  0/508 (0.00%) 
Cirrhosis of liver *  1/553 (0.18%)  0/508 (0.00%) 
Diarrhea *  1/553 (0.18%)  1/508 (0.20%) 
Gastritis *  1/553 (0.18%)  0/508 (0.00%) 
Gastroenteritis *  1/553 (0.18%)  0/508 (0.00%) 
Gastrointestinal hemorrhage *  1/553 (0.18%)  0/508 (0.00%) 
Ileus *  1/553 (0.18%)  0/508 (0.00%) 
Liver damage *  1/553 (0.18%)  0/508 (0.00%) 
Nausea *  6/553 (1.08%)  0/508 (0.00%) 
Stomach atony *  1/553 (0.18%)  0/508 (0.00%) 
Vomiting   6/553 (1.08%)  0/508 (0.00%) 
General disorders     
Abdominal pain *  1/553 (0.18%)  0/508 (0.00%) 
Abscess *  5/553 (0.90%)  0/508 (0.00%) 
Accidental injury *  0/553 (0.00%)  1/508 (0.20%) 
Allergic reaction *  1/553 (0.18%)  0/508 (0.00%) 
Asthenia *  0/553 (0.00%)  1/508 (0.20%) 
Carcinoma *  0/553 (0.00%)  1/508 (0.20%) 
Cellulitis *  1/553 (0.18%)  0/508 (0.00%) 
Chest pain *  2/553 (0.36%)  1/508 (0.20%) 
Fever *  4/553 (0.72%)  0/508 (0.00%) 
Gangrene *  3/553 (0.54%)  2/508 (0.39%) 
Infection *  9/553 (1.63%)  16/508 (3.15%) 
Pain *  0/553 (0.00%)  1/508 (0.20%) 
Sepsis *  1/553 (0.18%)  1/508 (0.20%) 
Septic shock *  1/553 (0.18%)  0/508 (0.00%) 
Sudden death *  1/553 (0.18%)  0/508 (0.00%) 
Local reaction to procedure *  0/553 (0.00%)  1/508 (0.20%) 
Metabolism and nutrition disorders     
Acidosis *  1/553 (0.18%)  0/508 (0.00%) 
Alkaline phosphatase increased *  0/553 (0.00%)  1/508 (0.20%) 
Dehydration *  1/553 (0.18%)  0/508 (0.00%) 
Diabetic ketoacidosis *  0/553 (0.00%)  1/508 (0.20%) 
Healing abnormal *  1/553 (0.18%)  1/508 (0.20%) 
Hypoglycemia *  3/553 (0.54%)  0/508 (0.00%) 
Hypoglycemic reaction *  0/553 (0.00%)  1/508 (0.20%) 
Lipase increased *  1/553 (0.18%)  0/508 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthrosis *  1/553 (0.18%)  1/508 (0.20%) 
Osteomyelitis *  17/553 (3.07%)  5/508 (0.98%) 
Pyogenic arthritis *  1/553 (0.18%)  0/508 (0.00%) 
Nervous system disorders     
Convulsion *  2/553 (0.36%)  4/508 (0.79%) 
Hallucinations *  0/553 (0.00%)  1/508 (0.20%) 
Hypesthesia *  0/553 (0.00%)  1/508 (0.20%) 
Mental status changes *  1/553 (0.18%)  1/508 (0.20%) 
Neuropathy *  0/553 (0.00%)  1/508 (0.20%) 
Somnolence *  1/553 (0.18%)  0/508 (0.00%) 
Stupor *  0/553 (0.00%)  1/508 (0.20%) 
Renal and urinary disorders     
Acute kidney failure *  1/553 (0.18%)  0/508 (0.00%) 
Kidney function abnormal *  0/553 (0.00%)  2/508 (0.39%) 
Urinary tract infection *  1/553 (0.18%)  0/508 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration *  0/553 (0.00%)  1/508 (0.20%) 
Aspiration pneumonia *  0/553 (0.00%)  1/508 (0.20%) 
Cough increased *  1/553 (0.18%)  0/508 (0.00%) 
Dyspnea *  2/553 (0.36%)  0/508 (0.00%) 
Lung edema *  1/553 (0.18%)  0/508 (0.00%) 
Pleuritic pain *  0/553 (0.00%)  1/508 (0.20%) 
Pneumonia *  2/553 (0.36%)  1/508 (0.20%) 
Respiratory failure *  1/553 (0.18%)  1/508 (0.20%) 
Skin and subcutaneous tissue disorders     
Skin necrosis *  4/553 (0.72%)  3/508 (0.59%) 
Skin ulcer *  2/553 (0.36%)  2/508 (0.39%) 
Vesiculobullous rash *  0/553 (0.00%)  1/508 (0.20%) 
Vascular disorders     
Arterial thrombosis *  1/553 (0.18%)  1/508 (0.20%) 
Deep vein thrombosis *  1/553 (0.18%)  0/508 (0.00%) 
Hemorrhage *  0/553 (0.00%)  1/508 (0.20%) 
Peripheral gangrene *  2/553 (0.36%)  0/508 (0.00%) 
Peripheral vascular disorder *  1/553 (0.18%)  2/508 (0.39%) 
Pulmonary embolus *  1/553 (0.18%)  0/508 (0.00%) 
Thrombophlebitis *  0/553 (0.00%)  1/508 (0.20%) 
Thrombosis *  0/553 (0.00%)  1/508 (0.20%) 
Vasculitis *  1/553 (0.18%)  0/508 (0.00%) 
Vascular disorder general *  1/553 (0.18%)  1/508 (0.20%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Tigecycline Ertapenem
Affected / at Risk (%) Affected / at Risk (%)
Total   406   292 
Blood and lymphatic system disorders     
Anemia *  14/553 (2.53%)  18/508 (3.54%) 
Cardiac disorders     
Hypertension *  36/553 (6.51%)  40/508 (7.87%) 
Gastrointestinal disorders     
Diarrhea *  75/553 (13.56%)  51/508 (10.04%) 
Dyspepsia *  19/553 (3.44%)  6/508 (1.18%) 
Nausea *  227/553 (41.05%)  46/508 (9.06%) 
Vomiting *  151/553 (27.31%)  25/508 (4.92%) 
General disorders     
Abdominal pain *  20/553 (3.62%)  11/508 (2.17%) 
Asthenia *  19/553 (3.44%)  8/508 (1.57%) 
Fever *  27/553 (4.88%)  19/508 (3.74%) 
Headache *  26/553 (4.70%)  20/508 (3.94%) 
Pain *  25/553 (4.52%)  17/508 (3.35%) 
Infection *  12/553 (2.17%)  19/508 (3.74%) 
Metabolism and nutrition disorders     
Hypoglycemia *  50/553 (9.04%)  24/508 (4.72%) 
Serum glutamic oxaloacetic transaminase (SGOT) increased *  20/553 (3.62%)  21/508 (4.13%) 
Serum glutamic pyruvic transaminase (SGPT) increased *  19/553 (3.44%)  20/508 (3.94%) 
Musculoskeletal and connective tissue disorders     
Osteomyelitis *  25/553 (4.52%)  12/508 (2.36%) 
Nervous system disorders     
Dizziness *  17/553 (3.07%)  10/508 (1.97%) 
Insomnia *  18/553 (3.25%)  5/508 (0.98%) 
Renal and urinary disorders     
Urogenital general *  24/553 (4.34%)  27/508 (5.31%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory system general *  32/553 (5.79%)  29/508 (5.71%) 
Skin and subcutaneous tissue disorders     
Skin and appendages general *  43/553 (7.78%)  28/508 (5.51%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Name/Title: U. S. Contact Center
Organization: Wyeth
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00366249     History of Changes
Other Study ID Numbers: 3074K5-319
First Submitted: August 17, 2006
First Posted: August 21, 2006
Results First Submitted: July 14, 2009
Results First Posted: August 21, 2009
Last Update Posted: April 28, 2010