Comparative Study of Ceftaroline vs. Ceftriaxone in Adult... | NCT00509106

Status Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ceftaroline fosamil for injection	Experimental	Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).	Drug: Ceftaroline fosamil for Injection
IV Ceftriaxone	Active Comparator	Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).	Drug: Ceftriaxone Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ceftaroline fosamil for Injection	Drug	2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours for 5 to 7 days	Ceftaroline fosamil for injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population	Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary Failure: Any of the following: Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia Death wherein pneumonia (ie,CABP) was considered causative Indeterminate: Inability to determine an outcome	8-15 days after last dose of study drug
Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population		8-15 days after last dose of study drug

Measure	Description	Time Frame
Clinical Response at End of Therapy (EOT)		Last day of study drug administration
Microbiological Success Rate at TOC		8-15 days after last dose of study drug

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
IM Hoepelman, MD	UMC Utrecht	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site		Durham	North Carolina	27710	United States
Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34922058	Derived	Dryden M, Kantecki M, Yan JL, Stone GG, Leister-Tebbe H, Wilcox M. Treatment outcomes of secondary bacteraemia in patients treated with ceftaroline fosamil: pooled results from six phase III clinical trials. J Glob Antimicrob Resist. 2022 Mar;28:108-114. doi: 10.1016/j.jgar.2021.10.027. Epub 2021 Dec 16.
30597021	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Ceftaroline Fosamil for Injection	Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
FG001	IV Ceftriaxone	Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Arm/Group Information

ID	Title	Description
BG000	Ceftaroline Fosamil for Injection	Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
BG001	IV Ceftriaxone	Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

<65 years

Title	Measurements
	BG000183 BG001173 BG002356

>=65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00059.0± 17.0 BG00160.0± 15.5 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000126 BG001105 BG002

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

Clinical Cure Rate for Ceftaroline Compared to That for Ceftriaxone at the Test of Cure (TOC) in the Modified Intent to Treat Efficacy (MITTE) Population

Cure:Total resolution of all signs and symptoms of pneumonia (ie,CABP), or improvement to such an extent that further antimicrobial therapy was not necessary

Failure: Any of the following:

Persistence, incomplete clinical resolution, or worsening in signs and symptoms of CABP that required alternative antimicrobial therapy
Treatment-limiting adverse event (AE) leading to discontinuation of study drug therapy, when subject required alternative antimicrobial therapy to treat the pneumonia
Death wherein pneumonia (ie,CABP) was considered causative

Indeterminate: Inability to determine an outcome

The MITTE Population consisted of all subjects in the MITT Population (all randomized subjects who received any amount of the study drug) in PORT Risk Class III or IV. The Pneumonia Outcomes Research Team (PORT) scale of CAP severity in which Risk Class I is associated with the lowest risk for mortality and Risk Class V represents the highest risk.

Posted

Number

participants

8-15 days after last dose of study drug

ID	Title	Description
OG000	Ceftaroline Fosamil for Injection	Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
OG001	IV Ceftriaxone	Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).

Units	Counts
Participants	OG000315 OG001307

Title

Denominators

Categories

Clinical cure

Title	Measurements
	OG000235 OG001206

Clinical 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	The primary objective of this study was to determine the noninferiority in the clinical cure rate for ceftaroline compared with that for ceftriaxone at TOC in the MITTE Population in adult subjects with CABP.					Risk Difference (RD)	5.9			2-Sided	95	-1.0	12.7			Risk difference corresponds to Ceftaroline clinical cure rate minus Ceftriaxone clinical cure rate. The confidence interval was calculated using the Miettinen and Nurminen method without adjustment.		Non-Inferiority or Equivalence	A two-sided 95% Confidence Interval (CI) for the observed difference in the primary outcome measure (clinical cure rate) between the ceftaroline group and the ceftriaxone group was calculated based on the MITTE Population at the TOC visit. Noninferiority was concluded if the lower limit of the 95% CI was higher than -10% for the MITTE populations.

Primary

Clinical Cure Rate for Ceftaroline Compared With That for Ceftriaxone at TOC in the Clinically Evaluable (CE) Population

Not Posted

8-15 days after last dose of study drug

Participants

Secondary

Clinical Response at End of Therapy (EOT)

Not Posted

Last day of study drug administration

Participants

Secondary

Microbiological Success Rate at TOC

Not Posted

8-15 days after last dose of study drug

Participants

Secondary

Overall Clinical and Radiographic Success Rate at TOC

Not Posted

8-15 days after last dose of study drug

Participants

Secondary

Clinical and Microbiological Response by Pathogen at TOC

Not Posted

8-15 days after last dose of study drug

Participants

Secondary

Clinical Relapse at Late Follow Up (LFU) Visit

Not Posted

21-35 days after last dose of study drug

Participants

Secondary

Microbiological Reinfection/Recurrence at LFU

Not Posted

21 to 35 days after last dose of study drug

Participants

Secondary

Evaluate Safety

Not Posted

first dose, throughout the treatment period, and up to the TOC visit

Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Ceftaroline Fosamil for Injection	Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).			41	315	67	315
EG001	IV Ceftriaxone	Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).			39	307	49	307

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Cardiac arrest	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Coronary artery disease	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Myocardial infarction	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Postinfarction angina	Cardiac disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Hypothyroidism	Endocrine disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Volvulus	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Pneumonia	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0007 events7 affected315 at risk EG0014 events4 affected307 at risk
Pyothorax	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected315 at risk EG0010 events0 affected307 at risk
Lung abscess	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected315 at risk EG0013 events3 affected307 at risk
Urinary tract infection	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected315 at risk EG0011 events1 affected307 at risk
Cellulitis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Sepsis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0011 events1 affected307 at risk
Septic shock	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Endocarditis	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Hepatitis C	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Staphylococcal bactgeraemia	Infections and infestations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Hepatic enzyme increased	Investigations	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0003 events3 affected315 at risk EG0010 events0 affected307 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Anoxic encephalopathy	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Convulsion	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Hemiplegia	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Renal failure	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected315 at risk EG0010 events0 affected307 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected315 at risk EG0015 events5 affected307 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected315 at risk EG0015 events5 affected307 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0004 events4 affected315 at risk EG0013 events3 affected307 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected315 at risk EG0010 events0 affected307 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0002 events2 affected315 at risk EG0010 events0 affected307 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0012 events2 affected307 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Asthmatic crisis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk
Cardiovascular insufficiency	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0001 events1 affected315 at risk EG0010 events0 affected307 at risk
Hypertensive crisis	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0000 events0 affected315 at risk EG0011 events1 affected307 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG00012 events12 affected315 at risk EG0019 events9 affected307 at risk
Nausea	Gastrointestinal disorders	MedDRA (11.1)	Systematic Assessment	EG0006 events6 affected315 at risk EG0016 events6 affected307 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA (11.1)	Systematic Assessment	EG00010 events10 affected315 at risk EG0015 events5 affected307 at risk
Headache	Nervous system disorders	MedDRA (11.1)	Systematic Assessment	EG00011 events11 affected315 at risk EG0015 events5 affected307 at risk
Insomnia	Psychiatric disorders	MedDRA (11.1)	Systematic Assessment	EG00010 events10 affected315 at risk EG0018 events8 affected307 at risk
Hypertension	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG0008 events8 affected315 at risk EG0018 events8 affected307 at risk
Phlebitis	Vascular disorders	MedDRA (11.1)	Systematic Assessment	EG00010 events10 affected315 at risk EG0018 events8 affected307 at risk

Ancestor Terms

ID	Term
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D011014	Pneumonia
D012141	Respiratory Tract Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D017714	Community-Acquired Infections
D016871	Pasteurellaceae Infections
D016905	Gram-Negative Bacterial Infections

Ancestor Terms

ID	Term
D002511	Cephalosporins
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D013843	Thiazines
D013457	Sulfur Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D004333	Drug Administration Routes
D004358	Drug Therapy
D013812	Therapeutics
D002439	Cefotaxime
D002505	Cephacetrile

ID	Term
D018410	Pneumonia, Bacterial
D000098968	Community-Acquired Pneumonia
D006192	Haemophilus Infections