Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 investigate daptomycin for managing various Gram-positive bacterial infections, including Staphylococcus aureus bacteremia, infective endocarditis, complicated skin and soft tissue infections, catheter-related bloodstream infections, and peritoneal infections. Sponsored by both academic medical institutions and pharmaceutical organizations, these studies evaluate drug pharmacokinetics, pharmacodynamics, safety, and therapeutic efficacy across diverse patient populations. Current trial statuses vary, encompassing active recruitment, completed evaluations, withdrawn protocols, and unknown statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06637332 RECRUITING
Staphylococcus Aureus Septicemia; Staphylococcus Aureus Bacteremia; S. Aureus Bacteremia; S. Aureus Bloodstream Infection; Staphylococcus Aureus Endocarditis
Todd C. Lee MD MPH FIDSA
 2024-11-14 PHASE4
NCT06189885 UNKNOWN
Periprosthetic Joint Infection
Chang Gung Memorial Hospital
 2024-08-01
NCT05977868 TERMINATED
Endovascular Infection; Bone and Joint Infection; Skin and Soft Tissue Infection; Pulmonary Infection; Gastrointestinal Infection; Genitourinary Infection
West Virginia University
 2023-08-04 PHASE4
NCT05156437 TERMINATED
Endocarditis
West Virginia University
 2022-03-16 PHASE4
NCT03480191 COMPLETED
Pneumococcal Meningitis
Centre Hospitalier Universitaire Dijon
 2018-06-07 PHASE2
NCT04983901 COMPLETED
Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
M.D. Anderson Cancer Center
 2021-09-14 PHASE2
NCT04775953 COMPLETED
Staphylococcal Bacteraemia
National Institute of Allergy and Infectious Diseases (NIAID)
 2021-04-22 PHASE2
NCT04141787 UNKNOWN
Staphylococcal Infections; Osteomyelitis; CNS Infection; Septic Arthritis; Diabetic Foot Infection; Vertebral Osteomyelitis; Abscess; Coagulase Negative Staphylococcal Infection
Vancouver Island Health Authority
 2019-07-11 PHASE4
NCT03138733 COMPLETED
Staphylococcus Aureus Bacteremia
Basilea Pharmaceutica
 2018-08-26 PHASE3
NCT04434300 COMPLETED
Antibiotics; Subcutaneous Injection; Daptomycin
University Hospital, Caen
 2020-10-15 PHASE1
NCT04277143 Unknown status
Outcome Fatal|Infection
Zhongnan Hospital
 2020-12-01 --
NCT04434300 Completed
Antibiotics|Subcutaneous Injection|Daptomycin
University Hospital Caen
 2020-10-15 Phase 1
NCT03643952 COMPLETED
Bacteremia; Soft Tissue Infections; Skin Diseases, Infectious
Merck Sharp & Dohme LLC
 2018-12-06 PHASE2
NCT01792804 COMPLETED
Staphylococcus Aureus Infection
Heinrich-Heine University, Duesseldorf
 2013-12 PHASE3
NCT02972983 COMPLETED
Methicillin Susceptible Staphylococcus Aureus Septicemia; Bacteremia
McGill University Health Centre/Research Institute of the McGill University Health Centre
 2016-12-01 PHASE4
NCT03643952 Completed
Bacteremia|Soft Tissue Infections|Skin Diseases Infectious
Merck Sharp & Dohme LLC
 2018-12-06 Phase 2
NCT01522105 TERMINATED
Meningitis
Insel Gruppe AG, University Hospital Bern
 2012-04 PHASE1
NCT02208063 TERMINATED
Bacteremia
Cumberland Pharmaceuticals
 2014-12 PHASE3
NCT01898338 COMPLETED
Staph Aureus Methicillin Resistant Bacteremia
Miquel Pujol
 2013-12 PHASE3
NCT02000414 COMPLETED
Peritoneal Infection
University Hospital, Caen
 2013-09
NCT02660346 COMPLETED
Bacteremia
Sharp HealthCare
 2015-11 PHASE4
NCT02241941 WITHDRAWN
Burn Injury
University of Zurich
 2014-09 PHASE4
NCT01922011 COMPLETED
Acute Hematogenous Osteomyelitis
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2013-09-13 PHASE3
NCT01728376 COMPLETED
Bacteremia
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2012-11-29 PHASE4
NCT01975662 TERMINATED
Bacteremia Due to Staphylococcus Aureus
Singapore General Hospital
 2014-01 PHASE2
NCT02508350 UNKNOWN
Septic Shock
Zhongda Hospital
 2015-01
NCT02142075 COMPLETED
Renal Failure; Critical Care; Gram Positive Bacteria
Poitiers University Hospital
 2014-03 PHASE3
NCT02097953 COMPLETED
Drug Interactions; Pharmacokinetics
University of Utah
 2014-05 EARLY_PHASE1
NCT01626560 COMPLETED
Cellulitis
Hospital Universitario Evangelico de Curitiba
 2012-07 PHASE4
NCT01592032 UNKNOWN
Catheter-Related Infections; Bacteremia.
Clinica Universidad de Navarra, Universidad de Navarra
 2012-05 PHASE4
NCT02052388 COMPLETED
Skin Infection; Bacterial Infection
Cellceutix Corporation
 2014-02 PHASE2
NCT01144000 UNKNOWN
Staphylococcal Infections
Andrej Trampuz
 2012-06 PHASE2
NCT01455246 TERMINATED
Cirrhosis; Ascites; Nosocomial Spontaneous Bacterial Peritonitis
University of Padova
 2010-10 PHASE2; PHASE3
NCT01012089 COMPLETED
Chronic Kidney Disease; Bacterial Infection
University of Oklahoma
 2009-11
NCT01196169 TERMINATED
Staphylococcal Infections; Methicillin-resistant Staphylococcus Aureus
Mountain Home Research & Education Corporation
 2010-10 PHASE4
NCT00711802 COMPLETED
Skin Diseases, Infectious
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2008-07-23 PHASE4
NCT01199783 TERMINATED
Diabetic Foot
Ruhr University of Bochum
 2011-07 PHASE3
NCT01549613 COMPLETED
Cellulitis; Skin Infections
University of Cincinnati
 2012-05 PHASE4
NCT01515020 TERMINATED
Nosocomial Infection; Healthcare-associated Infection
Assistance Publique - Hôpitaux de Paris
 2012-05 PHASE3
NCT01216241 TERMINATED
Febrile Neutropenia
University of Rochester
 2011-04 PHASE3
NCT01612052 UNKNOWN
MRSA - Methicillin Resistant Staphylococcus Aureus Infection
CAMC Health System
 2011-05 PHASE4
NCT01419184 COMPLETED
Staphylococcal Skin Infections
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2011-09-09 PHASE4
NCT00467272 COMPLETED
Bloodstream Infection
M.D. Anderson Cancer Center
 2007-03 PHASE2
NCT01734694 TERMINATED
Health Care Associated Pneumonia; Osteomyelitis/Septic Arthritis; Endocarditis; Bacteremia; Acute Bacterial Skin and Skin Structure Infections
Henry Ford Health System
 2011-10 PHASE4
NCT01133600 TERMINATED
Diabetic Foot
Clinical Alliance for Research & Education - Infectious Diseases, LLC.
 2010-08 PHASE4
NCT01104662 TERMINATED
Complicated Skin and Skin Structure Infections; S. Aureus Bacteremia; Renal Impairment
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2010-04-19 PHASE4
NCT01019395 COMPLETED
Gram Positive Bacterial Infection
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2010-01-05 PHASE1
NCT01080963 COMPLETED
Wound Infection
Hannover Medical School
 2008-11 PHASE4
NCT01287832 TERMINATED
Bacteremia
St. John Health System, Michigan
 2011-06 PHASE4
NCT00942149 COMPLETED
Sepsis
Duke University
 2010-01 PHASE1
NCT01211470 COMPLETED
Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA); (Susceptible or Methicillin Resistant)
PolyMedix, Inc.
 2010-10 PHASE2
NCT01175707 TERMINATED
Complicated Skin or Skin Structure Infection
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2010-07-15 PHASE4
NCT00638157 TERMINATED
Infective Endocarditis
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2009-02-13 PHASE4
NCT01025271 TERMINATED
Meningitis
University of Pittsburgh
 2010-05
NCT01184872 COMPLETED
Infections
Novartis Pharmaceuticals
 2010-03 PHASE3
NCT00701636 COMPLETED
Late Effects of Surgery; Staphylococcus Aureus; Surgical Site Infection
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2008-07 PHASE3
NCT00772447 COMPLETED
Skin Diseases; Infectious
AstraZeneca
 2008-09 PHASE3
NCT00695903 TERMINATED
Endocarditis, Bacterial; Infective Endocarditis
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2008-09-17 PHASE2
NCT00428844 COMPLETED
Osteomyelitis
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2007-06-26 PHASE2
NCT01212432 UNKNOWN
Gram-Positive Bacterial Infections
University of Zurich
 2009-12 PHASE2
NCT01171547 UNKNOWN
Bacteremia
University of Zurich
 2010-02 PHASE2
NCT00770341 COMPLETED
Staphylococcal Infection
Merck Sharp & Dohme LLC
 2008-09 PHASE3
NCT00882557 COMPLETED
End-stage Renal Disease; Renal Failure Chronic Requiring Hemodialysis
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2009-04-29 PHASE1
NCT00663403 COMPLETED
Critically Ill; Hemodialysis
University of Michigan
 2007-02 PHASE4
NCT00679835 COMPLETED
Gram Positive Infection; Concurrent Antibiotic Treatment
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2008-06-03 PHASE1
NCT00401960 TERMINATED
Endocarditis, Bacterial
Weill Medical College of Cornell University
 2006-09 PHASE4
NCT00335478 COMPLETED
Fever; Sweating; Hot Flashes; Infection; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific
OHSU Knight Cancer Institute
 2006-12 PHASE2
NCT00572260 TERMINATED
Antimicrobial Prophylaxis
Duke University
 2008-01 PHASE4
NCT00490737 COMPLETED
End-Stage Renal Disease
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2007-08-12 PHASE1
NCT00261807 COMPLETED
Fasciitis, Necrotizing; Severe Necrotizing Skin and Soft Tissue Infections; Fournier's Gangrene
University of Maryland, Baltimore
 2005-06
NCT00430937 TERMINATED
Skin Diseases, Infectious; Soft Tissue Infections
Novartis Pharmaceuticals
 2006-04 PHASE3
NCT00463801 TERMINATED
Staphylococcal Skin Infections
Novartis
 2007-01 PHASE4
NCT00507247 COMPLETED
Staphylococcus Aureus
M.D. Anderson Cancer Center
 2006-05 PHASE2
NCT00426933 COMPLETED
Soft Tissue Infections
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2007-01 PHASE2
NCT00102947 TERMINATED
Soft Tissue Infections
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2005-01 PHASE4
NCT00295178 COMPLETED
Cellulitis
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2006-02-20 PHASE4
NCT00136292 COMPLETED
Gram-positive Bacterial Infections
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2005-08-24 PHASE1
NCT00296049 WITHDRAWN
Infection; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific
Wake Forest University Health Sciences
 2005-07
NCT00651131 TERMINATED
Wound Infections
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2004-06-01 PHASE4
NCT00093067 COMPLETED
Bacterial Endocarditis; Bacteremia
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2002-03 PHASE3
NCT00055198 TERMINATED
Gram-Positive Bacterial Infections
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2002-12-19 PHASE3
NCT00540072 COMPLETED
Pneumonia, Bacterial
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2001-07-30 PHASE3
NCT00538694 COMPLETED
Pneumonia, Bacterial
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
 2000-10-31 PHASE3
NCT00451373 UNKNOWN
Acute Renal Failure; Sepsis; Postoperative
National Taiwan University Hospital
 2006-07
NCT00858325 COMPLETED
Healthy
AstraZeneca
 2009-02 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-31)

Check the Daptomycin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Daptomycin binds to bacterial cell membranes in a calcium-dependent manner, inserting its lipophilic tail into the phospholipid bilayer to disrupt membrane potential and trigger rapid ion leakage. This loss of membrane integrity inhibits intracellular macromolecular synthesis and induces rapid cell death, providing potent bactericidal activity against Gram-positive pathogens implicated in clinical conditions like Staphylococcus aureus bacteremia and soft tissue infections.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.