E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Complicated Skin and Soft Tissue Infections or Bacteremia caused by Gram-positive cocci |
|
E.1.1.1 | Medical condition in easily understood language |
Complicated Skin and Soft Tissue Infections or Bacteremia caused by Gram-positive cocci |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10060945 |
E.1.2 | Term | Bacterial infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the safety and tolerability of daptomycin. |
|
E.2.2 | Secondary objectives of the trial |
To assess the efficacy of administration of daptomycin in participants with methicillinresistant S. aureus (MRSA) infections.
To evaluate steady state pharmacokinetics of administration of daptomycin. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Requires treatment for cSSTI or bacteremia. - Is male or female Japanese aged ≥ 1 to ≤ 17 years on the day of signing informed consent. - As a male participant, has agreed to use contraception during the treatment period and for at least 14 days after the last dose of study treatment and refrain from donating sperm during this period. - As a female participant, has agreed to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 14 days after the last dose of study treatment. - Has agreed to allow any bacterial isolates obtained from protocol-required specimens related to the current infection to be provided the Central Microbiology Reference Laboratory for study-related microbiological testing, long-term storage, and other future testing.
cSSTI Participants - Has cSSTI known or suspected to be caused by Gram-positive cocci that requires intravenous antibiotic treatment and diagnosed with either Gram stain or culture. - Has at least 3 of the following clinical signs and symptoms associated with the cSSTI: pain, tenderness to palpation, temperature >37.0°C axillary or >37.5°C oral or >38.0° C rectal, forehead, or aural, white blood count (WBC) >12,000/mm^3 or ≥10% bands, swelling and/or induration, erythema (>1 cm beyond edge of wound or abscess), pus formation, CRP > upper limited of normal.
Bacteremia Participants - Have proven bacteremia with pathogen identification of Gram-positive cocci at least one blood culture bottle by conventional culture methods or by a rapid diagnostic test in screening period. - Have probable bacteremia with a blood culture result demonstrating Gram-positive cocci by Gram stain in screening period.
|
|
E.4 | Principal exclusion criteria |
- Has received previous systemic antimicrobial therapy that is effective against Gram positive cocci and exceeding 72 hours duration administered at any time during the 96 hours prior to the first dose of study drug. - Has a known infection caused solely by Gram-negative pathogen(s), fungus(i) or virus(es). - Has pneumonia (septic emboli in the lung is not an exclusion if clear evidence of source of infection is other than lungs), empyema, meningitis, endocarditis, or osteoarticular infection. - Has a history of or current rhabdomyolysis. - Is anticipated to require non-study systemic antibiotics that may be potentially effective against Gram-positive pathogen(s). - Has shock or hypotension unresponsive to fluids or vasopressors for ≥ 4 hours. - Has significant allergy/hypersensitivity or intolerance to daptomycin. - Has renal insufficiency. - Has a history of clinically significant (as assessed by the Investigator) muscular disease, nervous system or seizure disorder, including unexplained muscular weakness, history of peripheral neuropathy, Guillain-Barre or spinal cord injury; previous uncomplicated febrile seizure allowed. - Has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the participant to risk by participating in the trial, confound the results of the trial, or interfere with the participant's participation for the full duration of the trial. - Is a female who is pregnant or is expecting to conceive (or is a male partner of a female who is expecting to conceive), is breastfeeding, or plans to breastfeed prior to completion of the study. - Is currently participating in, or has participated in, any other clinical study involving the administration of investigational or experimental medication (not licensed by regulatory agencies) at the time of the presentation or during the previous 30 days prior to screening or is anticipated to participate in such a clinical study during the course of this trial. - Has previously participated in this study at any time. - Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this study.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Percentage of participants with an Adverse Event 2. Percentage of Participants that Discontinued Study Due to an AE
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Up to 14 days following end of therapy (EOT) (up to 56 days) 2. Up to 42 days
|
|
E.5.2 | Secondary end point(s) |
1. Percentage of Participants with Clinical Success 2. Percentage of Participants with Subject-Level Microbiological Success 3. Area Under the Concentration Time Curve from Time 0 to 24 Hours (AUC 0-24) Parameters 4. Mean Maximum Concentration (Cmax) 5. Median Time to Reach Maximum Plasma Concentration (Tmax) 6. Mean Total Body Clearance of Steady State (CLss/F) 7. Mean Volume of Distribution at Steady State (Vss) 8. Mean Apparent Half-life (t½)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Up to 10 days following EOT (up to 52 days) 2. Up to 10 days following EOT (up to 52 days) 3. At designated time points on Day 3 4. At designated time points on Day 3 5. At designated time points on Day 3 6. At designated time points on Day 3 7. At designated time points on Day 3 8. At designated time points on Day
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |