Antimicrobial PK in Infants With Suspected or Confirmed Infection

NCT00491426 | Completed DMC

• 2 other identifiers: Pro00015379PPRU 10824
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 6

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.

Conditions

Infection

Keywords

Infection; Anti-Infective Agents; Antifungal Agents; Proteomics

Study Arms (3)

<26 weeks

Subjects \<26 weeks gestational age

Drug: Ampicillin; Drug: Metronidazole; Drug: Piperacillin/Tazobactam; Drug: Acyclovir; Drug: Amphotericin B; Drug: Ambisome; Drug: Anidulafungin; Drug: Caspofungin

26-29 weeks

Subjects 26-29 weeks gestational age

Drug: Ampicillin; Drug: Metronidazole; Drug: Piperacillin/Tazobactam; Drug: Acyclovir; Drug: Amphotericin B; Drug: Ambisome; Drug: Anidulafungin; Drug: Caspofungin

30-32 weeks

Subjects 30-32 weeks gestational age

Drug: Ampicillin; Drug: Metronidazole; Drug: Piperacillin/Tazobactam; Drug: Acyclovir; Drug: Amphotericin B; Drug: Ambisome; Drug: Anidulafungin; Drug: Caspofungin

Interventions

Ampicillin DRUG

Drug prescribed per routine medical care.

26-29 weeks; 30-32 weeks; <26 weeks

Metronidazole DRUG

Drug prescribed per routine medical care.

26-29 weeks; 30-32 weeks; <26 weeks

Piperacillin/Tazobactam DRUG

Drug prescribed per routine medical care.

26-29 weeks; 30-32 weeks; <26 weeks

Acyclovir DRUG

Drug prescribed per routine medical care.

26-29 weeks; 30-32 weeks; <26 weeks

Amphotericin B DRUG

Drug prescribed per routine medical care.

26-29 weeks; 30-32 weeks; <26 weeks

Ambisome DRUG

Drug prescribed per routine medical care.

26-29 weeks; 30-32 weeks; <26 weeks

Anidulafungin DRUG

Drug prescribed per routine medical care.

26-29 weeks; 30-32 weeks; <26 weeks

Caspofungin DRUG

Drug prescribed per routine medical care.

26-29 weeks; 30-32 weeks; <26 weeks

Eligibility Criteria

• Age: Up to 120 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature infants \<32 weeks gestational age at birth at risk of infections.

You may qualify if:

• 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

You may not qualify if:

• Failure to consent

Sponsors & Collaborators

• Duke University: lead
• Pediatric Pharmacology Research Units Network: collaborator

Study Sites (6)

University of California at San Diego

La Jolla, California, 92103, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Children's Hospital of Michigan, Wayne State University

Detroit, Michigan, 48201, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Ampicillin; Metronidazole; Piperacillin, Tazobactam Drug Combination; Acyclovir; Amphotericin B; liposomal amphotericin B; Anidulafungin; Caspofungin

Intervention Hierarchy (Ancestors)

Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Tazobactam; Penicillanic Acid; Piperacillin; Sulfones; Drug Combinations; Pharmaceutical Preparations; Guanine; Hypoxanthines; Purinones; Purines; Macrolides; Polyketides; Lactones; Echinocandins; Peptides, Cyclic; Peptides; Amino Acids, Peptides, and Proteins; Lipopeptides; Lipids

Study Officials

• Danny Benjamin, MD

  PPRU

  PRINCIPAL INVESTIGATOR

• Mary Jayne Kennedy, Pharm, D

  Louisville-PPRU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2007
• First Posted: June 26, 2007
• Study Start: January 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

US (6)