Antimicrobial PK in Infants With Suspected or Confirmed Infection

Study Overview
=================
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 Guide dosing of commonly used antimicrobial agents, and Provide preliminary data for future industry and government trials in the nursery.

Official Title
-----------------
Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns - add-on Study)

Conditions
-----------------
Infection

Intervention / Treatment
-----------------
* Drug: Ampicillin
* Drug: Metronidazole
* Drug: Piperacillin/Tazobactam
* Drug: Acyclovir
* Drug: Amphotericin B
* Drug: Ambisome
* Drug: Anidulafungin
* Drug: Caspofungin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Maximum Age: 120 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infection, Anti-Infective Agents, Antifungal Agents, Proteomics