E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Gram Positive Bacterial Infection |
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E.1.1.1 | Medical condition in easily understood language |
Infections that are caused by a specific group of bacteria (called Gram-positive bacteria) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
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 |
This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 3 months to 24 months who have proven or suspected infections that are caused by a specific group of bacteria (called Gram-positive bacteria) or perioperative subjects that are receiving prophylactic antibiotics . |
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E.2.2 | Secondary objectives of the trial |
Safety of a single dose daptomycin in subjects between 3 and 24 months, who are receiving standard antibiotic therapy for a Gram-positive infection, including subjects that are receiving prophylactic antibiotics peri-operatively. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care
- Male or female between the ages of 3 months and 24 months, inclusive
- Able to comply with the protocol for the duration of the study
- Clinically stable with no evidence of hemodynamic instability (defined as a requirement for inotropic or vasodilatory support to manage blood pressure) in the
24 hour window prior to first dose, and no history or evidence of renal or hepatic
compromise
- Suspected or diagnosed bacterial infection for which the subject was receiving standard antibiotic therapy; including prophylactic use of antibiotics peri-operatively
- A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at Baseline
- Creatine kinase levels less than 2 × upper limit of normal (ULN) at Baseline
- Presence of two patent i.v. lines (or comparable means of venous or arterial access) prior to dosing on Study Day 1. A single i.v. line (or comparable means of venous access) was acceptable for both drug administration and sample collection if reasonable effort to gain a second line was unsuccessful. The line had to be flushed prior to obtaining PK samples. Pharmacokinetic sample could have been obtained from a peri-operatively placed arterial line. Arterial PK samples should have been indicated on the case report form (CRF). |
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E.4 | Principal exclusion criteria |
- Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry
- Known allergy/ hypersensitivity to daptomycin
- History of clinically significant, renal, hepatic, autoimmune disease or primary
immune deficiency
- Subjects with clinically significant abnormal laboratory test results (including ECGs), as determined by Investigator
- Administration of rifampin within 7 days of study drug administration
- Subjects in whom collection of the required blood volume would have put them at risk of hemodynamic disturbance (at the discretion of Investigator)
- Planned administration of intramuscular injection within 12 hours following study drug administration unless approved by the Medical Monitor
- Guillain-Barré or spinal cord injury
- History of or current rhabdomyolysis |
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E.5 End points |
E.5.1 | Primary end point(s) |
PK of single dose daptomycin in subjects between 3 and 24 months who are receiving standard antibiotic therapy for a Gram-positive infection, including subjects that are receiving prophylactic antibiotics peri-operatively |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Safety of a single dose daptomycin in subjects between 3 and 24 months, who are receiving standard antibiotic therapy for a Gram-positive infection, including subjects that are receiving prophylactic antibiotics peri-operatively |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |