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Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00240747
Enrollment
Unknown
Registered
2005-10-18
Start date
2000-06-30
Completion date
2005-01-31
Last updated
2012-05-25

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

Conditions

Gram-Positive Bacterial Infections

Brief summary

Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population pharmacokinetics of Synercid in pediatric patients and to collect additional safety and efficacy data in pediatric patients.

Interventions

DRUGSynercid

Sponsors

Aventis Pharmaceuticals
CollaboratorINDUSTRY
Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
27 Weeks to 16 Years
Healthy volunteers
No

Inclusion criteria

* Serious, suspected or documented gram-positive infection

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frame
Population pharmacokinetics

Secondary

MeasureTime frame
Safety
Efficacy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026