Antimicrobial PK in Infants With Suspected or Confirmed Infection

• Sponsor: Duke University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00491426
• Collaborator: Pediatric Pharmacology Research Units Network (Other)
• Enrollment: 450
• Locations: 6
• Duration (Months): 58
• Patients Per Site: 75
• Patients Per Site Per Month: 1.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection	Drug: Ampicillin; Drug: Metronidazole; Drug: Piperacillin/Tazobactam; Drug: Acyclovir; Drug: Amphotericin B; Drug: Ambisome; Drug: Anidulafungin; Drug: Caspofungin

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

1. Guide dosing of commonly used antimicrobial agents, and

2. Provide preliminary data for future industry and government trials in the nursery.

Study Design

• Study Type: Observational
• Actual Enrollment: 450 participants
• Time Perspective: Retrospective
• Official Title: Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns - add-on Study)
• Study Start Date: Jan 1, 2006
• Actual Primary Completion Date: Oct 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
<26 weeks Subjects <26 weeks gestational age	Drug: Ampicillin; Drug prescribed per routine medical care.; Drug: Metronidazole; Drug prescribed per routine medical care.; Drug: Piperacillin/Tazobactam; Drug prescribed per routine medical care.; Drug: Acyclovir; Drug prescribed per routine medical care.; Drug: Amphotericin B; Drug prescribed per routine medical care.; Drug: Ambisome; Drug prescribed per routine medical care.; Drug: Anidulafungin; Drug prescribed per routine medical care.; Drug: Caspofungin; Drug prescribed per routine medical care.
26-29 weeks Subjects 26-29 weeks gestational age	Drug: Ampicillin; Drug prescribed per routine medical care.; Drug: Metronidazole; Drug prescribed per routine medical care.; Drug: Piperacillin/Tazobactam; Drug prescribed per routine medical care.; Drug: Acyclovir; Drug prescribed per routine medical care.; Drug: Amphotericin B; Drug prescribed per routine medical care.; Drug: Ambisome; Drug prescribed per routine medical care.; Drug: Anidulafungin; Drug prescribed per routine medical care.; Drug: Caspofungin; Drug prescribed per routine medical care.
30-32 weeks Subjects 30-32 weeks gestational age	Drug: Ampicillin; Drug prescribed per routine medical care.; Drug: Metronidazole; Drug prescribed per routine medical care.; Drug: Piperacillin/Tazobactam; Drug prescribed per routine medical care.; Drug: Acyclovir; Drug prescribed per routine medical care.; Drug: Amphotericin B; Drug prescribed per routine medical care.; Drug: Ambisome; Drug prescribed per routine medical care.; Drug: Anidulafungin; Drug prescribed per routine medical care.; Drug: Caspofungin; Drug prescribed per routine medical care.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 120 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Infants ≤32 weeks and 6 days EGA with high probability of receiving one of the antimicrobial agents listed are eligible for study.

• Age younger than 120 days

• Written informed consent from parent or legal guardian

• Infants likely to survive beyond 48 hours after enrollment

Exclusion Criteria:

• Failure to consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California at San Diego	La Jolla	California	United States	92103
2	Children's National Medical Center	Washington	District of Columbia	United States	20010
3	Kosair Children's Hospital	Louisville	Kentucky	United States	40202
4	Children's Hospital of Michigan, Wayne State University	Detroit	Michigan	United States	48201
5	Duke University Medical Center	Durham	North Carolina	United States	27705
6	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75235

Sponsors and Collaborators

• Duke University
• Pediatric Pharmacology Research Units Network

Investigators

• Principal Investigator: Danny Benjamin, MD, PPRU
• Principal Investigator: Mary Jayne Kennedy, Pharm, D, Louisville-PPRU

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT00491426
• Other Study ID Numbers: Pro00015379; PPRU 10824
• First Posted: Jun 26, 2007
• Last Update Posted: Nov 19, 2012
• Last Verified: Nov 1, 2012

• Keywords provided by Duke University: Infection; Anti-Infective Agents; Antifungal Agents; Proteomics
• Additional relevant MeSH terms: Infections; Metronidazole; Tazobactam; Piperacillin; Amphotericin B; Liposomal amphotericin B; Acyclovir; Ampicillin; Caspofungin; Piperacillin, Tazobactam Drug Combination; Anidulafungin

Study Results

No Results Posted as of Nov 19, 2012