Study Comparing Cubicin With Vancomycin in Treatment of P... | NCT01175707

NCT01175707

ID	Type	Description	Link
DAP-4HOME-09-05	Other Identifier	Cubist Study Number

Status Module

Sponsor/Collaborators 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
Daptomycin	Experimental	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted	Drug: Daptomycin
Vancomycin	Active Comparator	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician	Drug: Vancomycin

Name	Type	Description	Arm Group Labels	Other Names
Daptomycin	Drug		Daptomycin	Cubicin
Vancomycin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time Spent (Minutes) for Home Infusion Therapy	Each participant is counted once per category. Avg=average; Admin=administer.	Day 1 up to Day 14
Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy	The mean duration in home-infusion antibiotic therapy per participant is presented.	Day 1 up to Day 14
Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy	Each participant is counted once per category.	Day 1 up to Day 14
Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy		Day 1 up to Day 14
Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy		Day 1 up to Day 14
Reasons for Nurse Visits During Home Infusion Therapy	The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant.	Day 1 up to Day 14
Reasons for Pharmacist Consultations During Home Infusion Therapy	The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.	Day 1 up to Day 14
Percentage of Treatment Goals Met at End of Therapy

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy	Type of interventions include Intravenous (IV) line replacement, IV line removal, IV line placement (post study therapy), Incision and drainage (wound), Incision and drainage (line), Debridement, Declotting procedure, and Blood draw.	Day 1 up to Day 14

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Paula Bokesch, MD	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Heartland I.V. Care		Livonia	Michigan	48150	United States
Heartland I.V. Care

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
FG001	Vancomycin

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

All study participants

Arm/Group Information

ID	Title	Description
BG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
BG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00040 BG00140 BG00280

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Total antibiotic therapy duration

Title	Measurements
	OG000160.7± 326.07 OG0011430.1± 1331.45

Total time to administer drug

Title	Measurements
	OG000

Primary

Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy

The mean duration in home-infusion antibiotic therapy per participant is presented.

All study participants.

Posted

Mean

Standard Deviation

Days

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants	OG000

Primary

Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy

Each participant is counted once per category.

All study participants.

Posted

Mean

Standard Deviation

Visits or Consultations per Participant

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants	OG000

Primary

Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy

Number of Participants Analyzed based on number of participants with at least one nurse visit/pharmacist consultation within each treatment group results in 39 participants analyzed for the Daptomycin ARM group for this Outcome Measure.

Posted

Number

Participants

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants

Primary

Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy

All study participants.

Posted

Number

Participants

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants	OG000

Primary

Reasons for Nurse Visits During Home Infusion Therapy

The reason for a participant's nurse visit is presented. There may be more than one reason for nurse visits per participant.

All study participants.

Posted

Number

Reason Cited

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants	OG000

Primary

Reasons for Pharmacist Consultations During Home Infusion Therapy

The reason for a participant's pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.

All study participants.

Posted

Number

Reason Cited

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants	OG000

Primary

Percentage of Treatment Goals Met at End of Therapy

Treatment goals included: 1. Elimination of infection/achieved desired response. 2. Laboratory values were within normal limits or improved indicating progress toward therapy goal. 3. Pain was controlled. 4. Participant did not have catheter site complications (eg,infection, loss of patency). 5. Participant had no knowledge deficits related to administration, equipment use, side effects and waste disposal. 6. Participant had no side effects, adverse drug reactions and/or drug or food interactions. 7. Signs and symptoms of infection did improve or resolve. 8. Participant was compliant with IV therapy 9. Successfully completed therapy without interruptions, unexpected hospitalizations. 10. Participant continued on an oral antibiotic. 11. Participant continued on an IV antibiotic.

Each participant's percentage was derived from number of treatment goals achieved out of a maximum of 11 goals. Reported percentage below is the average of all participants' percentage of goals met by arm.

All study participants.

Posted

Mean

Standard Deviation

Percentage of Goals Met

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Secondary

Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy

Type of interventions include Intravenous (IV) line replacement, IV line removal, IV line placement (post study therapy), Incision and drainage (wound), Incision and drainage (line), Debridement, Declotting procedure, and Blood draw.

All study participants.

Posted

Number

Participants

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants

Secondary

Mean Number of Interventions Per Participant During Home Infusion Therapy

Type of interventions include IV line replacement, IV line removal, IV line placement (post study therapy), incision and drainage (wound), incision and drainage (line), debridement, declotting procedure, and blood draw.

All study participants.

Posted

Mean

Standard Deviation

Interventions

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants

Secondary

Number of Intervention Types During Home Infusion Therapy

There may be more than one type of intervention per participant. A participant is counted only once for each category even if they had several instances of a given intervention.

All study participants

Posted

Number

participants

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants	OG000

Secondary

Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy

Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.

All study participants.

Posted

Number

Participants

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants	OG000

Secondary

Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy

Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.

All study participants.

Posted

Mean

Standard Deviation

Assessments

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants	OG000

Secondary

Number of Laboratory Assessment Types During Home Infusion Therapy

There may be more than one type of laboratory assessment per participant. A participant is counted only once for each category. Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough

All study participants.

Posted

Number

Assessments

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants

Secondary

Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant

Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.

All study participants.

Posted

Mean

Standard Deviation

US Dollars

Day 1 up to Day 14

ID	Title	Description
OG000	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
OG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.

Units	Counts
Participants	OG000

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	Daptomycin	500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.			7	40	13	40
EG001	Vancomycin	Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.			7	40	5	40

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Infection	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG0002 affected40 at risk EG0013 affected40 at risk
Cellulitis	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG0002 affected40 at risk EG0011 affected40 at risk
Device related infection	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected40 at risk
Gangrene	Infections and infestations	MedDRA Version 13.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected40 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 13.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected40 at risk
Renal failure acute	Renal and urinary disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected40 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected40 at risk
Blood creatinine increased	Investigations	MedDRA Version 13.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected40 at risk
White blood cell count increased	Investigations	MedDRA Version 13.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected40 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected40 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 13.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected40 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain upper	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected40 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected40 at risk
Asthenia	General disorders	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected40 at risk
Catheter site erythema	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected40 at risk
Catheter site haemorrhage	General disorders	MedDRA 13.0	Systematic Assessment	EG0002 events1 affected40 at risk EG0010 events0 affected40 at risk
Device occlusion	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected40 at risk
Infusion site pain	General disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected40 at risk
Medical device complication	General disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected40 at risk EG0010 events0 affected40 at risk
Hypersensitivity	Immune system disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected40 at risk
Abscess	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected40 at risk
Breast cellulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected40 at risk
Cellulitis	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0003 events2 affected40 at risk EG0010 events0 affected40 at risk
Fungal infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected40 at risk
Fungal skin infection	Infections and infestations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected40 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected40 at risk
Blood pressure increased	Investigations	MedDRA 13.0	Systematic Assessment	EG0000 events0 affected40 at risk EG0011 events1 affected40 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0010 events0 affected40 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0001 events1 affected40 at risk EG0013 events3 affected40 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 13.0	Systematic Assessment	EG0002 events2 affected40 at risk EG0010 events0 affected40 at risk

The study was terminated prematurely.

Certain Agreements

ID	Term
D017576	Daptomycin
D014640	Vancomycin

Ancestor Terms

ID	Term
D010456	Peptides, Cyclic
D047028	Macrocyclic Compounds
D011083	Polycyclic Compounds
D055666	Lipopeptides
D008055	Lipids
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D006020	Glycopeptides
D006001	Glycoconjugates
D002241	Carbohydrates

OG0011001.7± 696.76