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| ID | Type | Description | Link |
|---|---|---|---|
| 2008_564 |
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The study investigates the efficacy and safety of MK-3009 in participants with skin infections, septicemia and right-sided infective endocarditis (RIE) caused by methicillin-resistant Staphylococcus aureus (MRSA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-3009 (daptomycin) 4 mg/kg | Experimental |
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| Vancomycin | Active Comparator |
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| MK-3009 (daptomycin) 6 mg/kg | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daptomycin 4 mg/kg | Drug | MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI) |
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| Measure | Description | Time Frame |
|---|---|---|
| Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC) | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT). MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline. | 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE) |
| Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC | Response = eradicated or presumed eradicated. Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen. Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed "Cured" or "Improved" by the investigator and the participant did not receive potentially effective antibiotics for the pathogen. | 7-14 days for SSTI, 14-42 days for septicemia and RIE |
| Measure | Description | Time Frame |
|---|---|---|
| EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT). | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. | 7-14 days for SSTI, 14-42 days for septicemia and RIE |
| EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23085743 | Result | Aikawa N, Kusachi S, Mikamo H, Takesue Y, Watanabe S, Tanaka Y, Morita A, Tsumori K, Kato Y, Yoshinari T. Efficacy and safety of intravenous daptomycin in Japanese patients with skin and soft tissue infections. J Infect Chemother. 2013 Jun;19(3):447-55. doi: 10.1007/s10156-012-0501-9. Epub 2012 Oct 20. | |
| 26072149 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | MK-3009 (Daptomycin) 4 mg/kg | Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI) |
| FG001 | Vancomycin | IV Vancomycin 1 g twice daily for SSTI |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Comparator: vancomycin | Drug | vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days |
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| Daptomycin 6 mg/kg | Drug | MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis |
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Response = eradicated or presumed eradicated. Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen. Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed "Cured" or "Improved" by the investigator and the participant did not receive potentially effective antibiotics for the pathogen. |
| 7-14 days for SSTI, 14-42 days for septicemia and RIE |
| Study Investigators' Assessment of Clinical Response at EOT | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. | 7-14 days for SSTI, 14-42 days for septicemia and RIE |
| Study Investigators' Assessment of Clinical Response at TOC | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. | 7-14 days for SSTI, 14-42 days for septicemia and RIE |
| Takesue Y, Mikamo H, Kusachi S, Watanabe S, Takahashi K, Yoshinari T, Ishii M, Aikawa N. Correlation between pharmacokinetic/pharmacodynamic indices and clinical outcomes in Japanese patients with skin and soft tissue infections treated with daptomycin: analysis of a phase III study. Diagn Microbiol Infect Dis. 2015 Sep;83(1):77-81. doi: 10.1016/j.diagmicrobio.2015.05.013. Epub 2015 May 28. |
| FG002 | MK-3009 (Daptomycin) 6 mg/kg | IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE) |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MK-3009 (Daptomycin) 4 mg/kg | Intravenous (IV) Daptomycin 4 mg/kg once daily for skin & soft tissue infections (SSTI) |
| BG001 | Vancomycin | IV Vancomycin 1 g twice daily for SSTI |
| BG002 | MK-3009 (Daptomycin) 6 mg/kg | IV Daptomycin 6 mg/kg once daily for Septicemia and right-sided infective endocarditis (RIE) |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age information was for all treated participants (N=121) | Mean | Standard Deviation | years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Clinical Success at Test of Cure (TOC) | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at end of treatment (EOT). MITT-MRSA (modified intent-to-treat - methicillin-resistant Staphylococcus aureus) was a subset of allocated participants with participants who were excluded for any of the following reasons: no MRSA isolated + any 1 of the following: failure to receive ≥1 dose of study drug, lack of all post-allocation primary and secondary endpoint data after ≥1 dose of study drug, no gram (+) coccus isolated at baseline. | MITT-MRSA; One participant with possible MRSA RIE was enrolled. This participant was excluded from the efficacy population. | Posted | Number | Participants | 7-14 days for SSTI, 14-42 days for septicemia and right-sided infective endocarditis (RIE) |
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| Secondary | EAC Assessment of Number of Participants With Clinical Success at End of Treatment (EOT). | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. | MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population. | Posted | Number | Participants | 7-14 days for SSTI, 14-42 days for septicemia and RIE |
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| |||||||||||||||||||||||||||||||||
| Primary | Efficacy Adjudication Committee (EAC) Assessment of Number of Participants With Microbiological Response at TOC | Response = eradicated or presumed eradicated. Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen. Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed "Cured" or "Improved" by the investigator and the participant did not receive potentially effective antibiotics for the pathogen. | MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population. | Posted | Number | Participants | 7-14 days for SSTI, 14-42 days for septicemia and RIE |
| ||||||||||||||||||||||||||||||||||
| Secondary | EAC Assessment of Number of Participants With Microbiological Response at End of Treatment (EOT). | Response = eradicated or presumed eradicated. Eradicated was defined as absence of the admission pathogen in a culture obtained in the absence of potentially effective antibiotics for the pathogen. Presumed eradicated was defined as no material for culture was available due to improvement of infection, but the admission pathogen was presumed to be eradicated because the participant was deemed "Cured" or "Improved" by the investigator and the participant did not receive potentially effective antibiotics for the pathogen. | MITT-MRSA; one participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population. | Posted | Number | Participants | 7-14 days for SSTI, 14-42 days for septicemia and RIE |
| ||||||||||||||||||||||||||||||||||
| Secondary | Study Investigators' Assessment of Clinical Response at EOT | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. | MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population. | Posted | Number | Participants | 7-14 days for SSTI, 14-42 days for septicemia and RIE |
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| Secondary | Study Investigators' Assessment of Clinical Response at TOC | Clinical Success = Study investigator's Clinical Response confirmed by the EAC as either cured or improved at EOT. | MITT-MRSA; One participant with possible MRSA RIE was enrolled into this study. This participant was excluded from the efficacy population. | Posted | Number | Participants | 7-14 days for SSTI, 14-42 days for septicemia and RIE |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NOT TREATED | 0 | 1 | 0 | 1 | |||
| EG001 | DAPTOMYCIN (4 MG/KG) | 6 | 88 | 34 | 88 | |||
| EG002 | VANCOMYCIN | 4 | 22 | 11 | 22 | |||
| EG003 | DAPTOMYCIN (6 MG/KG) | 4 | 11 | 9 | 11 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DUODENAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| INTRA-ABDOMINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| ANAPHYLACTIC SHOCK | Immune system disorders | MedDRA 11.0 | Systematic Assessment |
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| INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| PNEUMONIA | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| SEPSIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| SKELETAL INJURY | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| ELECTROCARDIOGRAM ST SEGMENT DEPRESSION | Investigations | MedDRA 11.0 | Systematic Assessment |
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| HYPOALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| HYPOPHARYNGEAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
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| AORTIC ANEURYSM RUPTURE | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ARRHYTHMIA | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| CARDIAC FAILURE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| VERTIGO | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| DENTAL CARIES | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| GASTRIC VOLVULUS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| ILEUS PARALYTIC | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| PERITONITIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| OEDEMA | General disorders | MedDRA 11.0 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 11.0 | Systematic Assessment |
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| PAIN | General disorders | MedDRA 11.0 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 11.0 | Systematic Assessment |
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| ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| ABSCESS LIMB | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| ARTHRITIS INFECTIVE | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| CATHETER RELATED INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| JOINT ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| MUSCLE ABSCESS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
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| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
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| BLOOD BILIRUBIN INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
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| BLOOD POTASSIUM INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
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| BLOOD URINE PRESENT | Investigations | MedDRA 11.0 | Systematic Assessment |
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| C-REACTIVE PROTEIN INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
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| EOSINOPHIL COUNT INCREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
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| GLUCOSE URINE PRESENT | Investigations | MedDRA 11.0 | Systematic Assessment |
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| HAEMOGLOBIN DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
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| PLATELET COUNT DECREASED | Investigations | MedDRA 11.0 | Systematic Assessment |
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| MALNUTRITION | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| PYURIA | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
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| ATELECTASIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| HAEMOPTYSIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| ANGIOPATHY | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@Merck.com |
| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017576 | Daptomycin |
| ID | Term |
|---|---|
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
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