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Study Comparing Cubicin With Vancomycin in Treatment of Participants With Complicated Skin and Skin Structure Infections in a Home Infusion Setting

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ClinicalTrials.gov Identifier: NCT01175707
Recruitment Status : Terminated (Business decision)
First Posted : August 5, 2010
Results First Posted : May 13, 2015
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Cubist Pharmaceuticals LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition Complicated Skin or Skin Structure Infection
Interventions Drug: Daptomycin
Drug: Vancomycin
Enrollment 80
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description 500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted. 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.
Period Title: Overall Study
Started 40 40
Completed 36 34
Not Completed 4 6
Reason Not Completed
Adverse Event             4             6
Arm/Group Title Daptomycin Vancomycin Total
Hide Arm/Group Description 500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted. 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. Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
All study participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
58.55  (14.387) 56.78  (19.366) 57.665  (16.8765)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
19
  47.5%
21
  52.5%
40
  50.0%
Male
21
  52.5%
19
  47.5%
40
  50.0%
1.Primary Outcome
Title Time Spent (Minutes) for Home Infusion Therapy
Hide Description Each participant is counted once per category. Avg=average; Admin=administer.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Minutes
Total antibiotic therapy duration 160.7  (326.07) 1430.1  (1331.45)
Total time to administer drug 87.6  (132.66) 1001.7  (696.76)
Avg time per day to administer drug 6.64  (8.221) 127.78  (59.565)
Avg time to admin drug per infusion 6.64  (8.221) 95.81  (23.566)
Total caregiver time to admin drug 261.8  (494.86) 1336  (1527.67)
Avg caregiver time per day to admin drug 16.66  (21.376) 148.66  (174.709)
Avg caregiver time per infusion to admin drug 16.66  (21.376) 124.25  (175.856)
Total nursing time 393.0  (229.34) 404.2  (321.42)
Avg nursing time per visit 73.25  (17.920) 85.80  (23.907)
Avg nursing time per day 73.97  (17.759) 87.79  (25.382)
Total time for pharmacist consultations 60.4  (29.59) 55.3  (35.67)
2.Primary Outcome
Title Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy
Hide Description The mean duration in home-infusion antibiotic therapy per participant is presented.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Days
13.0  (6.05) 11.0  (6.11)
3.Primary Outcome
Title Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy
Hide Description Each participant is counted once per category.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Visits or Consultations per Participant
Total number of nursing visits 5.8  (3.90) 5.0  (4.18)
Total number of scheduled nursing visits 4.1  (1.91) 4.4  (3.98)
Total number of unscheduled nursing visits 4.91  (4.0) 1.24  (1.0)
Total number of pharmacist consultations 9.6  (4.22) 9.6  (5.79)
4.Primary Outcome
Title Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy
Hide Description [Not Specified]
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 39 40
Measure Type: Number
Unit of Measure: Participants
12 15
5.Primary Outcome
Title Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy
Hide Description [Not Specified]
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Participants
40 40
6.Primary Outcome
Title Reasons for Nurse Visits During Home Infusion Therapy
Hide Description The reason for a participant’s nurse visit is presented. There may be more than one reason for nurse visits per participant.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
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.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Reason Cited
Laboratory assessment 36 36
Participant/Caregiver teaching 26 29
Site/Catheter care 5 10
Clinical assessment 1 2
Other 28 19
7.Primary Outcome
Title Reasons for Pharmacist Consultations During Home Infusion Therapy
Hide Description The reason for a participant’s pharmacist consultation is presented. There may be more than one reason for pharmacist consultations per participant.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Reason Cited
Development/revision of care plan 25 25
Review of written reports of participant status 16 20
Review of related labs and other studies 38 36
Communication - participant 38 37
Communication - prescriber 26 25
Communication - home care nurse 25 20
Communication - integration of new information 3 4
Other 13 13
8.Primary Outcome
Title Percentage of Treatment Goals Met at End of Therapy
Hide Description

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.

Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Percentage of Goals Met
74.98  (10.842) 75.21  (11.823)
9.Secondary Outcome
Title Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy
Hide Description 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.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Participants
Had at least 1 intervention 9 4
Had no intervention 31 36
10.Secondary Outcome
Title Mean Number of Interventions Per Participant During Home Infusion Therapy
Hide Description 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.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Interventions
1.8  (1.30) 1.5  (0.58)
11.Secondary Outcome
Title Number of Intervention Types During Home Infusion Therapy
Hide Description 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.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
IV line replacement 2 0
Incision and drainage (wound) 0 1
De-clotting procedure 3 2
Other 6 2
12.Secondary Outcome
Title Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy
Hide Description Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and Vancomycin trough.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Participants
40 40
13.Secondary Outcome
Title Mean Number of Laboratory Assessments Per Participant During Home Infusion Therapy
Hide Description Laboratory assessments include serum creatinine, creatine phosphokinase (CPK), and vancomycin trough.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: Assessments
2.7  (1.19) 2.8  (1.24)
14.Secondary Outcome
Title Number of Laboratory Assessment Types During Home Infusion Therapy
Hide Description 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
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: Assessments
Serum creatinine 40 40
CPK 39 0
Vancomycin 1 38
15.Secondary Outcome
Title Health Economic Outcomes in United States (US) Dollars for Home Infusion Therapy Per Participant
Hide Description Total Heartland costs per participant were derived by summing the costs of drug, pharmacy services/supplies and nursing.
Time Frame Day 1 up to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
All study participants.
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description:
500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
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.
Overall Number of Participants Analyzed 40 40
Mean (Standard Deviation)
Unit of Measure: US Dollars
Total Drug Costs 2762.37  (1446.140) 107.14  (69.264)
Pharmacy Service and Supplies Costs 641.25  (247.263) 596.25  (278.472)
Nursing Costs 637.63  (404.868) 583.02  (475.495)
Total Heartland Costs 3956.25  (1781.020) 1273.02  (667.673)
Emergency Room (ER) Visit Costs 1660.31  (761.630) 1518  (533.370)
Lost Work Costs 3729.13  (3753.586) 3635.60  (6404.213)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daptomycin Vancomycin
Hide Arm/Group Description 500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted. 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-Cause Mortality
Daptomycin Vancomycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Daptomycin Vancomycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/40 (17.50%)      7/40 (17.50%)    
Blood and lymphatic system disorders     
Lymphadenopathy  1  1/40 (2.50%)  0/40 (0.00%) 
Infections and infestations     
Infection  1  2/40 (5.00%)  3/40 (7.50%) 
Cellulitis  1  2/40 (5.00%)  1/40 (2.50%) 
Device related infection  1  0/40 (0.00%)  1/40 (2.50%) 
Gangrene  1  0/40 (0.00%)  1/40 (2.50%) 
Investigations     
Blood creatinine increased  1  0/40 (0.00%)  1/40 (2.50%) 
White blood cell count increased  1  0/40 (0.00%)  1/40 (2.50%) 
Metabolism and nutrition disorders     
Gout  1  1/40 (2.50%)  0/40 (0.00%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  1/40 (2.50%)  0/40 (0.00%) 
Renal and urinary disorders     
Haematuria  1  0/40 (0.00%)  1/40 (2.50%) 
Renal failure acute  1  1/40 (2.50%)  0/40 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 13.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Daptomycin Vancomycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/40 (32.50%)      5/40 (12.50%)    
Gastrointestinal disorders     
Abdominal pain upper  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Diarrhoea  1  0/40 (0.00%)  0 1/40 (2.50%)  1
General disorders     
Asthenia  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Catheter site erythema  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Catheter site haemorrhage  1  1/40 (2.50%)  2 0/40 (0.00%)  0
Device occlusion  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Infusion site pain  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Medical device complication  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Immune system disorders     
Hypersensitivity  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Infections and infestations     
Abscess  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Breast cellulitis  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Cellulitis  1  2/40 (5.00%)  3 0/40 (0.00%)  0
Fungal infection  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Fungal skin infection  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Investigations     
Blood creatine phosphokinase increased  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Blood pressure increased  1  0/40 (0.00%)  0 1/40 (2.50%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/40 (2.50%)  1 0/40 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash  1  1/40 (2.50%)  1 3/40 (7.50%)  3
Urticaria  1  2/40 (5.00%)  2 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.0
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 first publication is initiated by Cubist. If First Publication not published within 1 year of Study conclusion or termination, Investigator has right to publish and disclose the Data. Prior to any submission for publication, presentation, or communication of results or information arising from the Study, Investigator shall provide Cubist at least 90 days for review and comment upon the manuscript or other material for such publication or presentation.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Vice President, Clinical Research
Organization: Cubist Pharmaceuticals
Phone: 781-860-8318
Layout table for additonal information
Responsible Party: Cubist Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT01175707     History of Changes
Other Study ID Numbers: 3009-009
DAP-4HOME-09-05 ( Other Identifier: Cubist Study Number )
First Submitted: July 20, 2010
First Posted: August 5, 2010
Results First Submitted: April 5, 2013
Results First Posted: May 13, 2015
Last Update Posted: December 25, 2018