Study Comparing Tigecycline Versus Ceftriaxone Sodium Plu... | NCT00195351

Status Module

Label	Type	Description	Intervention Names
A	Active Comparator		Drug: tigecycline
B	Active Comparator		Drug: ceftriaxone sodium + metronidazole

Name	Type	Description	Arm Group Labels	Other Names
tigecycline	Drug	every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.	The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.	10-21 days after the last dose of test article

Secondary Outcomes

Measure	Description	Time Frame
Number of Microbiologically Evaluable Patients With a Clinical Response of Cure at Test-of-Cure (TOC) Visit.	The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.

Name	Affiliation	Role
Medical Monitor	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

PubMed Identifier	Type	Citation	Retractions
20670293	Derived	Towfigh S, Pasternak J, Poirier A, Leister H, Babinchak T. A multicentre, open-label, randomized comparative study of tigecycline versus ceftriaxone sodium plus metronidazole for the treatment of hospitalized subjects with complicated intra-abdominal infections. Clin Microbiol Infect. 2010 Aug;16(8):1274-81. doi: 10.1111/j.1469-0691.2010.03122.x.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Tigecycline	Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
FG001	Ceftriaxone Sodium + Metronidazole	Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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 Clinically Evaluable Patients With Clinical Response of Cure at Test-of-Cure (TOC) Visit.

The clinical response was assigned by the investigator according to the protocol-specified guidelines. A clinical response of cure was defined as: the test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection.

All patients who received ≥1 dose of study drug, who had clinical evidence of complicated intra-abdominal infection, met all inclusion and exclusion criteria, and completed TOC assessment within 8-44 days after last dose of study drug. Patients with an indeterminate assessment were excluded.

Posted

Feb 2009

Number

participants

10-21 days after the last dose of test article

ID	Title	Description
OG000	Tigecycline	Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
OG001	Ceftriaxone Sodium + Metronidazole	Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.

Units	Counts
Participants	OG000189 OG001187

Title

Denominators

Categories

Title	Measurements
	OG000133 OG001139

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		t-test, 2 sided		0.009		Risk Difference (RD)	-4.0				95	-13.1	5.1				No	Superiority or Other

Secondary

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

All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had a baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.

Posted

Feb 2009

Number

participants

10-21 days after the last dose of test article

ID	Title	Description
OG000	Tigecycline	Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
OG001	Ceftriaxone Sodium + Metronidazole	Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.

Units	Counts

Secondary

Number of Patients by Microbiologic Response at Test-of-Cure (TOC) Visit.

Microbiologic response assessed at patient level was combined microbiologic responses for all baseline isolates identified in intra-abdominal/blood cultures. Eradication=baseline isolate not recovered from primary infection site/blood; Presumed Eradication=no material available for culture but response was cure; Persistence=baseline isolate recovered from primary infection site/blood; Presumed Persistence=no material available for culture but response was failure; Superinfection=culture from primary infection site was positive for new isolate not identified at baseline & response was failure.

All patients who received ≥1 dose, had clinical evidence of complicated intra-abdominal infection, met all inclusion/exclusion criteria, completed TOC assessment within 8-44 days after last dose, and had baseline culture with ≥1 identified isolate that was susceptible to both study drugs. Patients with an indeterminate assessment were excluded.

Posted

Feb 2009

Number

participants

10-21 days after the last dose of test article

ID	Title	Description
OG000	Tigecycline	Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
OG001	Ceftriaxone Sodium + Metronidazole	Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Abscess	General disorders	Non-systematic Assessment	EG00018 affected236 at risk EG00113 affected231 at risk
Infection	General disorders	Non-systematic Assessment	EG0003 affected236 at risk EG0014 affected231 at risk
Abdominal pain	General disorders	Non-systematic Assessment	EG0003 affected236 at risk EG0013 affected231 at risk
Lymphocele	General disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0014 affected231 at risk
Peritonitis	General disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0012 affected231 at risk
Sepsis	General disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0013 affected231 at risk
Chest pain	General disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0011 affected231 at risk
Septic shock	General disorders	Non-systematic Assessment	EG0002 affected236 at risk EG0010 affected231 at risk
Hemoperitoneum	General disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Mesenteric fibrosis	General disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Retroperitoneal hemorrhage	General disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Traumatic hematoma	General disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Ileus	Gastrointestinal disorders	Non-systematic Assessment	EG0003 affected236 at risk EG0013 affected231 at risk
Intestinal obstruction	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected236 at risk EG0013 affected231 at risk
Gastrointestinal carcinoma	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected236 at risk EG0011 affected231 at risk
Cholestatic jaundice	Gastrointestinal disorders	Non-systematic Assessment	EG0002 affected236 at risk EG0010 affected231 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Gastrointestinal disorder	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Gastrointestinal hemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Hematemesis	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Intestinal necrosis	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Melena	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0002 affected236 at risk EG0015 affected231 at risk
Pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0013 affected231 at risk
Aspiration pneumonia	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0011 affected231 at risk
Respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0012 affected231 at risk
Carcinoma of the lung	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Pulmonary embolus	Cardiac disorders	Non-systematic Assessment	EG0003 affected236 at risk EG0011 affected231 at risk
Atrial fibrillation	Cardiac disorders	Non-systematic Assessment	EG0002 affected236 at risk EG0010 affected231 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0002 affected236 at risk EG0010 affected231 at risk
Hypotension	Cardiac disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0011 affected231 at risk
Myocardial infarct	Cardiac disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0012 affected231 at risk
Cerebral ischemia	Vascular disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Cerebrovascular accident	Vascular disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Congestive heart failure	Cardiac disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Coronary artery disorder	Cardiac disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Heart arrest	Cardiac disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Hemorrhage	Vascular disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Mesenteric venous occousion	Vascular disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Healing abdominal	Metabolism and nutrition disorders	Non-systematic Assessment	EG0003 affected236 at risk EG0011 affected231 at risk
Acidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Blood urea nitrogen increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Thrombocythemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0002 affected236 at risk EG0010 affected231 at risk
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
International normalized ratio increased	Blood and lymphatic system disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Acute kidney failure	Renal and urinary disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk
Pyelonephritis	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Urinary retention	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0010 affected231 at risk
Trauma	General disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0011 affected231 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG00091 affected236 at risk EG00164 affected231 at risk
Vomiting	Gastrointestinal disorders	Non-systematic Assessment	EG00055 affected236 at risk EG00141 affected231 at risk
Diarrhea	Gastrointestinal disorders	Non-systematic Assessment	EG00042 affected236 at risk EG00140 affected231 at risk
Constipation	Gastrointestinal disorders	Non-systematic Assessment	EG00014 affected236 at risk EG00114 affected231 at risk
Ileus	Gastrointestinal disorders	Non-systematic Assessment	EG0008 affected236 at risk EG00116 affected231 at risk
Abdominal distension	Gastrointestinal disorders	Non-systematic Assessment	EG0005 affected236 at risk EG00111 affected231 at risk
Dyspepsia	Gastrointestinal disorders	Non-systematic Assessment	EG0009 affected236 at risk EG0014 affected231 at risk
Oral moniliasis	Gastrointestinal disorders	Non-systematic Assessment	EG0008 affected236 at risk EG0011 affected231 at risk
Abdominal pain	General disorders	Non-systematic Assessment	EG00022 affected236 at risk EG00116 affected231 at risk
Abscess	General disorders	Non-systematic Assessment	EG00023 affected236 at risk EG00115 affected231 at risk
Headache	General disorders	Non-systematic Assessment	EG00014 affected236 at risk EG00122 affected231 at risk
Fever	General disorders	Non-systematic Assessment	EG00017 affected236 at risk EG00118 affected231 at risk
Infection	General disorders	Non-systematic Assessment	EG00017 affected236 at risk EG0019 affected231 at risk
Generalized edema	General disorders	Non-systematic Assessment	EG0001 affected236 at risk EG0017 affected231 at risk
Hypokalemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG00016 affected236 at risk EG00121 affected231 at risk
Healing abdominal	Metabolism and nutrition disorders	Non-systematic Assessment	EG0009 affected236 at risk EG0018 affected231 at risk
Hyperglycemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0009 affected236 at risk EG0018 affected231 at risk
Peripheral edema	Metabolism and nutrition disorders	Non-systematic Assessment	EG0009 affected236 at risk EG0017 affected231 at risk
Hypoproteinemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG00011 affected236 at risk EG0014 affected231 at risk
Amylase increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG0008 affected236 at risk EG0014 affected231 at risk
Hypophophatemia	Metabolism and nutrition disorders	Non-systematic Assessment	EG0003 affected236 at risk EG0019 affected231 at risk
SGPT increased	Metabolism and nutrition disorders	Non-systematic Assessment	EG0007 affected236 at risk EG0015 affected231 at risk
Insomina	Nervous system disorders	Non-systematic Assessment	EG00023 affected236 at risk EG00124 affected231 at risk
Anxiety	Nervous system disorders	Non-systematic Assessment	EG0007 affected236 at risk EG00112 affected231 at risk
Confusion	Nervous system disorders	Non-systematic Assessment	EG0008 affected236 at risk EG0012 affected231 at risk
Pharyngitis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0009 affected236 at risk EG0018 affected231 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0006 affected236 at risk EG00110 affected231 at risk
Pulmonary physical findings	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0007 affected236 at risk EG0016 affected231 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0005 affected236 at risk EG0017 affected231 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0004 affected236 at risk EG0017 affected231 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Non-systematic Assessment	EG0000 affected236 at risk EG0017 affected231 at risk
Thrombocythemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG00013 affected236 at risk EG00115 affected231 at risk
Anemia	Blood and lymphatic system disorders	Non-systematic Assessment	EG00016 affected236 at risk EG0018 affected231 at risk
Leukocytosis	Blood and lymphatic system disorders	Non-systematic Assessment	EG00019 affected236 at risk EG0014 affected231 at risk
Hypertension	Cardiac disorders	Non-systematic Assessment	EG0009 affected236 at risk EG00111 affected231 at risk
Deep vein thrombosis	Vascular disorders	Non-systematic Assessment	EG0008 affected236 at risk EG0011 affected231 at risk
Pruritus	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG00013 affected236 at risk EG00112 affected231 at risk
Rash	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0004 affected236 at risk EG0017 affected231 at risk
Local reaction to procedure	Surgical and medical procedures	Non-systematic Assessment	EG00018 affected236 at risk EG00114 affected231 at risk
Taste perversion	General disorders	Non-systematic Assessment	EG0002 affected236 at risk EG0019 affected231 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama	36617	United States

ID	Term
D001064	Appendicitis
D002764	Cholecystitis
D003428	Cross Infection
D004238	Diverticulitis
D010538	Peritonitis

ID	Term
D059413	Intraabdominal Infections
D007239	Infections
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D002429	Cecal Diseases
D007410	Intestinal Diseases
D005705	Gallbladder Diseases
D001660	Biliary Tract Diseases
D007049	Iatrogenic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000076385	Diverticular Diseases
D010532	Peritoneal Diseases

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D011083	Polycyclic Compounds
D002439	Cefotaxime
D002505	Cephacetrile
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D013843	Thiazines
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D009593	Nitroimidazoles
D009574	Nitro Compounds
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring

ID	Title	Description
BG000	Tigecycline	Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
BG001	Ceftriaxone Sodium + Metronidazole	Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
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	Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).			51		195
EG001	Ceftriaxone Sodium + Metronidazole	Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.			49		189