Antimicrobial PK in Infants With Suspected or Confirmed Infection
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 22, 2007 | ||||||||
| Last Updated Date | August 31, 2011 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00491426 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Current Other Outcome Measures ICMJE | |||||||||
| Original Other Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Antimicrobial PK in Infants With Suspected or Confirmed Infection | ||||||||
| Official Title ICMJE | Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns - add-on Study) | ||||||||
| Brief Summary | The purpose of this protocol is to provide a mechanism for the ongoing collection of blood and urine samples in newborns that will be used to measure levels of antimicrobial products used in the newborn population where there are limited pharmacokinetic data in either premature or term infants. |
||||||||
| Detailed Description | Greater than 90% of infants born <32 weeks admitted to critical care nurseries are treated with antimicrobial agents during their NICU hospitalization. Most antimicrobial products used in the neonatal population lack some aspect of pharmacokinetic information specific to neonates. Dosing is based largely on pharmacokinetic data from older children or in some cases, adults. This study will also establish a bank of urine samples from newborns treated with antimicrobial and/or antifungal therapy and to characterize the urinary proteome in selected samples. The sites of the NIH-sponsored Pediatric Pharmacology Research Network (PPRU) have access to appropriate assays using microliter amounts of serum and a large pool of potential subjects to generate meaningful data that will
|
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Retrospective | ||||||||
| Biospecimen | |||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Premature infants <32 weeks gestational age at birth at risk of infections. |
||||||||
| Condition ICMJE | Infection | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Group/Cohort (s) |
|
||||||||
| Publications * | |||||||||
|
* 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 | Completed | ||||||||
| Enrollment ICMJE | 450 | ||||||||
| Completion Date | November 2010 | ||||||||
| Primary Completion Date | October 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | up to 120 Days | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00491426 | ||||||||
| Other Study ID Numbers ICMJE | PPRU 10824 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Michael Cohen-Wolkowiez, Duke University | ||||||||
| Study Sponsor ICMJE | Duke University | ||||||||
| Collaborators ICMJE | Pediatric Pharmacology Research Units Network | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Duke University | ||||||||
| Verification Date | August 2011 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||
