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An Evaluation of the safety, Efficacy and Pharmacokinetics of daptomycin in pediatric subjects aged one to seventeen years with complicated skin and skin structure infections caused by Gram Positive Pathogens.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-006-13
Enrollment
15
Registered
2013-06-11
Start date
2013-06-28
Completion date
Unknown
Last updated
2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Vial: Powder lyophylisate for solution for infusion for Intravenous. Age Group 4: For ages 1-<2 years: 10 mg/kg i.v. q24 hrs for up to 14 days

Sponsors

Cubist Pharmaceuticals, Inc,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 2 Years

Inclusion criteria

Inclusion criteria: •1. Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care; 2. Written subject assent (as appropriate); 3.1 Male or female between the ages of 1 to 17 years old, inclusive; The resto of the information is regsiter in the protocol

Exclusion criteria

Exclusion criteria: • 1. Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry; 2. Known allergy/ hypersensitivity to daptomycin; 3. Known infection caused solely by Gram-negative pathogen(s), fungus(i) or virus(es) The resto of the information is regsiter in the protocol

Countries

Guatemala, Panama, Peru, United States

Contacts

Public ContactELIZABETH ROSPIGLIOSI

I3 LATIN AMERICA PERU S.A.

elizabeth.rospigliosi@i3global.com6164102

Outcome results

None listed

Source: REPEC (via WHO ICTRP)