Study Evaluating the Safety and Efficacy of a Once-daily... | NCT00366249

NCT00366249

Label	Type	Description	Intervention Names
A	Active Comparator		Drug: Tigecycline
B	Active Comparator		Drug: Ertapenem

Name	Type	Description	Arm Group Labels	Other Names
Tigecycline	Drug	150 mg Tigecycline once-daily IV infusion for up to 28 days, or 42 days for the substudy wth osteomyelitis	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Patients With Clinical Response of Cure Vs. Failure.	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.	Test of cure visit (TOC): Assessed at least 12 days post last dose
Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.	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.	Test of cure visit (TOC): Assessed at least 12 days post last dose

Secondary Outcomes

Measure	Description	Time Frame
Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.	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.	Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director
Trial Manager	For Belgium, trials-BEL@wyeth.com	Principal Investigator
Trial Manager	For Hungary, WPBUMED@wyeth.com	Principal Investigator
Trial Manager	For Spain, infomed@wyeth.com	Principal Investigator
Trial Manager	For Taiwan, medinfo@wyeth.com	Principal Investigator
Trial Manager	For South Africa, ZAFinfo@wyeth.com	Principal Investigator
Trial Manager	For Canada, clintrialparticipation@wyeth.com	Principal Investigator
Trial Manager	For Australia, medinfo@wyeth.com	Principal Investigator
Trial Manager	For Austria, WPVIMED@wyeth.com	Principal Investigator
Trial Manager

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90010	United States

PubMed Identifier	Type	Citation	Retractions
24439136	Derived	Lauf L, Ozsvar Z, Mitha I, Regoly-Merei J, Embil JM, Cooper A, Sabol MB, Castaing N, Dartois N, Yan J, Dukart G, Maroko R. Phase 3 study comparing tigecycline and ertapenem in patients with diabetic foot infections with and without osteomyelitis. Diagn Microbiol Infect Dis. 2014 Apr;78(4):469-80. doi: 10.1016/j.diagmicrobio.2013.12.007. Epub 2013 Dec 16.

ID	Title	Description
FG000	Tigecycline	Tigecycline 150 mg IV infusion every 24 hours
FG001	Ertapenem	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).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Patients With Clinical Response of Cure Vs. Failure.

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.

Clinically evaluable population without osteomyelitis.

Posted

Jul 2009

Number

patients

Test of cure visit (TOC): Assessed at least 12 days post last dose

ID	Title	Description
OG000	Tigecycline	Tigecycline 150 mg IV infusion every 24 hours
OG001	Ertapenem	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).

Units	Counts
Participants	OG000408 OG001405

Title

Denominators

Categories

Cure

Title	Measurements
	OG000316 OG001334

Failure

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Analysis provided for Cure					Mehrotra and Railker	-5.5				95	-11.0	0.1			Adjusted for Perfusion, Extent, Depth/tissue loss, Infection, and Sensation (PEDIS) score	Yes	Non-Inferiority or Equivalence	Statistical analysis tested for non-inferiority. Non-inferiority margin is -10%.

Secondary

Number of Patients With Clinical Response of Cure Vs. Failure Assessed at Least 25 - 27 Weeks Post Last Dose.

Clinically evaluable population with osteomyelitis.

Posted

Jul 2009

Number

patients

Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose

ID	Title	Description
OG000	Tigecycline	Tigecycline 150 mg IV infusion every 24 hours
OG001	Ertapenem	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).

Units	Counts
Participants	OG000

Primary

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate.

Clinical modified intent to treat population without osteomyelitis.

Posted

Jul 2009

Number

patients

Test of cure visit (TOC): Assessed at least 12 days post last dose

ID	Title	Description
OG000	Tigecycline	Tigecycline 150 mg IV infusion every 24 hours
OG001	Ertapenem	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).

Units	Counts
Participants

Secondary

Number of Patients With Clinical Response of Cure Vs. Failure/Indeterminate Assessed at Least 25 - 27 Weeks Post Last Dose.

Clinical modified intent to treat population with osteomyelitis.

Posted

Jul 2009

Number

patients

Test of cure visit (TOC): Assessed at least 25 - 27 weeks post last dose

ID	Title	Description
OG000	Tigecycline	Tigecycline 150 mg IV infusion every 24 hours
OG001	Ertapenem	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).

Units	Counts
Participants

Secondary

Number of Patients With Microbiologic Response of Eradication.

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.

Microbiologically evaluable population without osteomyelitis.

Posted

Jul 2009

Number

patients

Test of cure visit (TOC): Assessed at least 12 days post last dose

ID	Title	Description
OG000	Tigecycline	Tigecycline 150 mg IV infusion every 24 hours
OG001	Ertapenem	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).

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal pain	General disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Abscess	General disorders	Non-systematic Assessment	EG0005 affected553 at risk EG0010 affected508 at risk
Accidental injury	General disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Allergic reaction	General disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Asthenia	General disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Carcinoma	General disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Cellulitis	General disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0002 affected553 at risk EG0011 affected508 at risk
Fever	General disorders	Non-systematic Assessment	EG0004 affected553 at risk EG0010 affected508 at risk
Gangrene	General disorders	Non-systematic Assessment	EG0003 affected553 at risk EG0012 affected508 at risk
Infection	General disorders	Non-systematic Assessment	EG0009 affected553 at risk EG00116 affected508 at risk
Pain	General disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Sepsis	General disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0011 affected508 at risk
Septic shock	General disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Sudden death	General disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Arterial thrombosis	Vascular disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0011 affected508 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0002 affected553 at risk EG0010 affected508 at risk
Bundle branch block	Cardiac disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Cardiomegaly	Cardiac disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Cerebral ischemia	Cardiac disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Cerebrovascular accident	Cardiac disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0012 affected508 at risk
Congestive heart failure	Cardiac disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0012 affected508 at risk
Coronary artery disorder	Cardiac disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Heart arrest	Cardiac disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Heart failure	Cardiac disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Hemorrhage	Vascular disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Myocardial infarct	Cardiac disorders	Non-systematic Assessment	EG0004 affected553 at risk EG0010 affected508 at risk
Occlusion	Cardiac disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0012 affected508 at risk
Peripheral gangrene	Vascular disorders	Non-systematic Assessment	EG0002 affected553 at risk EG0010 affected508 at risk
Peripheral vascular disorder	Vascular disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0012 affected508 at risk
Pulmonary embolus	Vascular disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Shock	Cardiac disorders	Non-systematic Assessment	EG0002 affected553 at risk EG0010 affected508 at risk
Syncope	Cardiac disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0012 affected508 at risk
Tachycardia	Cardiac disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Thrombophlebitis	Vascular disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Thrombosis	Vascular disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Vasculitis	Vascular disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Cholelithiasis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Cirrhosis of liver	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0011 affected508 at risk
Gastritis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Gastroenteritis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Ileus	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Liver damage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0006 affected553 at risk EG0010 affected508 at risk
Stomach atony	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0006 affected553 at risk EG0010 affected508 at risk
Leukocytosis	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Neutropenia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Acidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Alkaline phosphatase increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Dehydration	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Healing abnormal	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0011 affected508 at risk
Hypoglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0003 affected553 at risk EG0010 affected508 at risk
Hypoglycemic reaction	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Lipase increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Arthrosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0011 affected508 at risk
Osteomyelitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00017 affected553 at risk EG0015 affected508 at risk
Pyogenic arthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Convulsion	Nervous system disorders	Non-systematic Assessment	EG0002 affected553 at risk EG0014 affected508 at risk
Hallucinations	Nervous system disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Hypesthesia	Nervous system disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Mental status changes	Nervous system disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0011 affected508 at risk
Neuropathy	Nervous system disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Somnolence	Nervous system disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Stupor	Nervous system disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Aspiration pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Cough increased	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected553 at risk EG0010 affected508 at risk
Lung edema	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected553 at risk EG0011 affected508 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0011 affected508 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0004 affected553 at risk EG0013 affected508 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0002 affected553 at risk EG0012 affected508 at risk
Vesiculobullous rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Acute kidney failure	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Kidney function abnormal	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0012 affected508 at risk
Urinary tract infection	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0010 affected508 at risk
Local reaction to procedure	General disorders	Non-systematic Assessment	EG0000 affected553 at risk EG0011 affected508 at risk
Left heart failure	Cardiac disorders	Non-systematic Assessment	EG0002 affected553 at risk EG0010 affected508 at risk
Vascular disorder general	Vascular disorders	Non-systematic Assessment	EG0001 affected553 at risk EG0011 affected508 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abdominal pain	General disorders	Non-systematic Assessment	EG00020 affected553 at risk EG00111 affected508 at risk
Asthenia	General disorders	Non-systematic Assessment	EG00019 affected553 at risk EG0018 affected508 at risk
Respiratory system general	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG00032 affected553 at risk EG00129 affected508 at risk
Fever	General disorders	Non-systematic Assessment	EG00027 affected553 at risk EG00119 affected508 at risk
Headache	General disorders	Non-systematic Assessment	EG00026 affected553 at risk EG00120 affected508 at risk
Skin and appendages general	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG00043 affected553 at risk EG00128 affected508 at risk
Pain	General disorders	Non-systematic Assessment	EG00025 affected553 at risk EG00117 affected508 at risk
Urogenital general	Renal and urinary disorders	Non-systematic Assessment	EG00024 affected553 at risk EG00127 affected508 at risk
Hypertension	Cardiac disorders	Non-systematic Assessment	EG00036 affected553 at risk EG00140 affected508 at risk
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG00075 affected553 at risk EG00151 affected508 at risk
Dyspepsia	Gastrointestinal disorders	Non-systematic Assessment	EG00019 affected553 at risk EG0016 affected508 at risk
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG000227 affected553 at risk EG00146 affected508 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG000151 affected553 at risk EG00125 affected508 at risk
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG00014 affected553 at risk EG00118 affected508 at risk
Hypoglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG00050 affected553 at risk EG00124 affected508 at risk
Serum glutamic oxaloacetic transaminase (SGOT) increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG00020 affected553 at risk EG00121 affected508 at risk
Serum glutamic pyruvic transaminase (SGPT) increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG00019 affected553 at risk EG00120 affected508 at risk
Osteomyelitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG00025 affected553 at risk EG00112 affected508 at risk
Dizziness	Nervous system disorders	Non-systematic Assessment	EG00017 affected553 at risk EG00110 affected508 at risk
Insomnia	Nervous system disorders	Non-systematic Assessment	EG00018 affected553 at risk EG0015 affected508 at risk
Infection	General disorders	Non-systematic Assessment	EG00012 affected553 at risk EG00119 affected508 at risk

ID	Term
D001424	Bacterial Infections
D017719	Diabetic Foot
D010019	Osteomyelitis
D048909	Diabetes Complications
D016523	Foot Ulcer
D002481	Cellulitis

ID	Term
D001423	Bacterial Infections and Mycoses
D007239	Infections
D003925	Diabetic Angiopathies
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D007871	Leg Ulcer
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D003920	Diabetes Mellitus
D004700	Endocrine System Diseases
D003929	Diabetic Neuropathies
D001850	Bone Diseases, Infectious
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D005534	Foot Diseases
D012874	Skin Diseases, Infectious
D013492	Suppuration
D003240	Connective Tissue Diseases
D007249	Inflammation
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D015780	Carbapenems
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

ID	Title	Description
BG000	Tigecycline	Tigecycline 150 mg IV infusion every 24 hours
BG001	Ertapenem	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).
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Tigecycline	Tigecycline 150 mg IV infusion every 24 hours			79		406
EG001	Ertapenem	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).			62		292