NCT01175707 is a Phase 4 clinical trial of Daptomycin in Complicated Skin or Skin Structure Infection, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).

What drugs are being tested in NCT01175707?

Interventions in NCT01175707: Daptomycin, Vancomycin.

What condition does NCT01175707 study?

NCT01175707 studies Complicated Skin or Skin Structure Infection.

Is NCT01175707 still recruiting?

NCT01175707 is currently terminated. Last updated 26 December 2018.

Are results published for NCT01175707?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-12-26 · How we verify

NCT01175707

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 4 Results posted Last updated 26 December 2018

What this trial tests

Phase 4 trial testing Daptomycin in Complicated Skin or Skin Structure Infection in 80 participants. Terminated before completion.

Timeline

15 July 2010

Primary endpoint
17 November 2011

17 November 2011

Quick facts

Lead sponsor	Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	80
Start date	15 July 2010
Primary completion	17 November 2011
Estimated completion	17 November 2011
Sites	4 locations across United States

Drugs / interventions tested

Daptomycin (Daptomycin) — full drug profile →
Vancomycin (vancomycin) — full drug profile →

Conditions studied

Complicated Skin or Skin Structure Infection — all drugs for Complicated Skin or Skin Structure Infection →

Sponsor

Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) — full company profile →

Who can join

18 and older, any sex, with Complicated Skin or Skin Structure Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time Spent (Minutes) for Home Infusion Therapy Primary · Day 1 up to Day 14

Each participant is counted once per category. Avg=average; Admin=administer.

Total antibiotic therapy duration

Group	Value	95% CI
Daptomycin	160.7	± 326.07
Vancomycin	1430.1	± 1331.45

Total time to administer drug

Group	Value	95% CI
Daptomycin	87.6	± 132.66
Vancomycin	1001.7	± 696.76

Avg time per day to administer drug

Group	Value	95% CI
Daptomycin	6.64	± 8.221
Vancomycin	127.78	± 59.565

Avg time to admin drug per infusion

Group	Value	95% CI
Daptomycin	6.64	± 8.221
Vancomycin	95.81	± 23.566

Total caregiver time to admin drug

Group	Value	95% CI
Daptomycin	261.8	± 494.86
Vancomycin	1336	± 1527.67

Avg caregiver time per day to admin drug

Group	Value	95% CI
Daptomycin	16.66	± 21.376
Vancomycin	148.66	± 174.709

Avg caregiver time per infusion to admin drug

Group	Value	95% CI
Daptomycin	16.66	± 21.376
Vancomycin	124.25	± 175.856

Total nursing time

Group	Value	95% CI
Daptomycin	393.0	± 229.34
Vancomycin	404.2	± 321.42

Total Antibiotic Therapy Duration (in Days) Per Participant for Home Infusion Therapy Primary · Day 1 up to Day 14

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

Group	Value	95% CI
Daptomycin	13.0	± 6.05
Vancomycin	11.0	± 6.11

Number of Nurse Visits or Consultations Per Participant for Home Infusion Therapy Primary · Day 1 up to Day 14

Each participant is counted once per category.

Total number of nursing visits

Group	Value	95% CI
Daptomycin	5.8	± 3.90
Vancomycin	5.0	± 4.18

Total number of scheduled nursing visits

Group	Value	95% CI
Daptomycin	4.1	± 1.91
Vancomycin	4.4	± 3.98

Total number of unscheduled nursing visits

Group	Value	95% CI
Daptomycin	4.91	± 4.0
Vancomycin	1.24	± 1.0

Total number of pharmacist consultations

Group	Value	95% CI
Daptomycin	9.6	± 4.22
Vancomycin	9.6	± 5.79

Number of Participants With at Least 1 Unscheduled Nursing Visit During Home Infusion Therapy Primary · Day 1 up to Day 14

Group	Value	95% CI
Daptomycin	12
Vancomycin	15

Number of Participants With at Least One Pharmacist Consultation During Home Infusion Therapy Primary · Day 1 up to Day 14

Group	Value	95% CI
Daptomycin	40
Vancomycin	40

Reasons for Nurse Visits During Home Infusion Therapy Primary · Day 1 up to Day 14

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

Laboratory assessment

Group	Value	95% CI
Daptomycin	36
Vancomycin	36

Participant/Caregiver teaching

Group	Value	95% CI
Daptomycin	26
Vancomycin	29

Site/Catheter care

Group	Value	95% CI
Daptomycin	5
Vancomycin	10

Clinical assessment

Group	Value	95% CI
Daptomycin	1
Vancomycin	2

Other

Group	Value	95% CI
Daptomycin	28
Vancomycin	19

Reasons for Pharmacist Consultations During Home Infusion Therapy Primary · Day 1 up to Day 14

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

Development/revision of care plan

Group	Value	95% CI
Daptomycin	25
Vancomycin	25

Review of written reports of participant status

Group	Value	95% CI
Daptomycin	16
Vancomycin	20

Review of related labs and other studies

Group	Value	95% CI
Daptomycin	38
Vancomycin	36

Communication - participant

Group	Value	95% CI
Daptomycin	38
Vancomycin	37

Communication - prescriber

Group	Value	95% CI
Daptomycin	26
Vancomycin	25

Communication - home care nurse

Group	Value	95% CI
Daptomycin	25
Vancomycin	20

Communication - integration of new information

Group	Value	95% CI
Daptomycin	3
Vancomycin	4

Other

Group	Value	95% CI
Daptomycin	13
Vancomycin	13

Percentage of Treatment Goals Met at End of Therapy Primary · Day 1 up to Day 14

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 t

Group	Value	95% CI
Daptomycin	74.98	± 10.842
Vancomycin	75.21	± 11.823

Number of Participants With at Least 1 Intervention Related to Complicated Skin or Skin Structure Infection (cSSSI) During Home Infusion Therapy Secondary · Day 1 up to Day 14

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.

Had at least 1 intervention

Group	Value	95% CI
Daptomycin	9
Vancomycin	4

Had no intervention

Group	Value	95% CI
Daptomycin	31
Vancomycin	36

Mean Number of Interventions Per Participant During Home Infusion Therapy Secondary · Day 1 up to Day 14

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.

Group	Value	95% CI
Daptomycin	1.8	± 1.30
Vancomycin	1.5	± 0.58

Number of Intervention Types During Home Infusion Therapy Secondary · Day 1 up to Day 14

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.

IV line replacement

Group	Value	95% CI
Daptomycin	2
Vancomycin	0

Incision and drainage (wound)

Group	Value	95% CI
Daptomycin	0
Vancomycin	1

De-clotting procedure

Group	Value	95% CI
Daptomycin	3
Vancomycin	2

Other

Group	Value	95% CI
Daptomycin	6
Vancomycin	2

Participants Who Had More Than 1 Laboratory Assessment During Home Infusion Therapy Secondary · Day 1 up to Day 14

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

Group	Value	95% CI
Daptomycin	40
Vancomycin	40

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Daptomycin

Serious: 7/40 (18%)

Deaths: —

Vancomycin

Serious: 7/40 (18%)

Deaths: —

Serious adverse events (11 terms)

Reaction	System	Daptomycin	Vancomycin
Infection	Infections and infestations	—	—
Cellulitis	Infections and infestations	—	—
Device related infection	Infections and infestations	—	—
Gangrene	Infections and infestations	—	—
Haematuria	Renal and urinary disorders	—	—
Renal failure acute	Renal and urinary disorders	—	—
Lymphadenopathy	Blood and lymphatic system disorders	—	—
Blood creatinine increased	Investigations	—	—
White blood cell count increased	Investigations	—	—
Gout	Metabolism and nutrition disorders	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (19 terms — click to expand)

Reaction	System	Daptomycin	Vancomycin
Rash	Skin and subcutaneous tissue disorders	—	—
Medical device complication	General disorders	—	—
Cellulitis	Infections and infestations	—	—
Urticaria	Skin and subcutaneous tissue disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Asthenia	General disorders	—	—
Catheter site erythema	General disorders	—	—
Catheter site haemorrhage	General disorders	—	—
Device occlusion	General disorders	—	—
Infusion site pain	General disorders	—	—
Hypersensitivity	Immune system disorders	—	—
Abscess	Infections and infestations	—	—
Breast cellulitis	Infections and infestations	—	—
Fungal infection	Infections and infestations	—	—
Fungal skin infection	Infections and infestations	—	—
Blood creatine phosphokinase increased	Investigations	—	—
Blood pressure increased	Investigations	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Infection, Cellulitis, Device related infection, Gangrene, Haematuria, Renal failure acute, Lymphadenopathy, Blood creatinine increased.

Data from ClinicalTrials.gov NCT01175707 adverse events section.

Sponsor's own description

This is a randomized, open-label, multi-center, phase 4 study designed to compare intravenous (IV) daptomycin and IV vancomycin administered in a home infusion setting for the treatment of complicated skin and skin structure infections (cSSSI) due to Gram-positive bacteria in participants who are prescribed vancomycin for 7 to 14 days and who are planning to receive vancomycin in a home-infusion setting.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Daptomycin

Trials testing the same drug.

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Other Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials

Trials by the same sponsor.

NCT02276482 — Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012) · Phase 3 · completed
NCT02387372 — Plasma Pharmacokinetics (PK) & Lung Penetration of Ceftolozane/Tazobactam in Participants With Pneumonia (MK-7625A-007) · Phase 1 · completed
NCT02341599 — Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compare · Phase 1 · completed
NCT02266706 — Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Pr · Phase 1 · completed
NCT02070757 — Safety and Efficacy Study of Ceftolozane/Tazobactam to Treat Ventilated Nosocomial Pneumonia (MK-7625A-008) · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01175707 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Last refreshed: 26 December 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01175707.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01175707

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (11 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Daptomycin

Other Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) trials

Verify against primary sources