Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
NCT00240747
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Gram-Positive Bacterial Infections
Sex
Females and Males
Age
27 + weeks
Inclusion Criteria
Show details
- Serious, suspected or documented gram-positive infection
Exclusion Criteria
Show details
-
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Gram-Positive Bacterial InfectionsOpen-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients
NCT00240747
- Oakland, California
- Orange, California
- Durham, North Carolina
- Cincinnati, Ohio
- Cleveland, Ohio
- Tulsa, Oklahoma
ALL GENDERS
27 Weeks+
years
MULTIPLE SITES
Gram-Positive Bacterial InfectionsStudy Evaluating Vancomycin-Resistant Enterococci in a Hematology Unit
NCT00167960
- Incheon,
- Ulsan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Gram-Positive Bacterial InfectionsPost Marketing Surveillance Study on Linezolid
NCT01564758
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients | |||
Official Title ICMJE | Not Provided | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Gram-Positive Bacterial Infections | |||
Intervention ICMJE | Drug: Synercid | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Enrollment ICMJE | Not Provided | |||
Original Enrollment ICMJE | Not Provided | |||
Study Completion Date ICMJE | January 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 27 Weeks to 16 Years (Child) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00240747 | |||
Other Study ID Numbers ICMJE | RP59500V-324 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Aventis Pharmaceuticals | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |