- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00491426
Antimicrobial PK in Infants With Suspected or Confirmed Infection
Antimicrobial Pharmacokinetics in High Risk Infants (Urinary Proteomics in Antimicrobial/Antifungal-Treated Newborns - add-on Study)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
California
-
La Jolla, California, Forente stater, 92103
- University of California at San Diego
-
-
District of Columbia
-
Washington, District of Columbia, Forente stater, 20010
- Children's National Medical Center
-
-
Kentucky
-
Louisville, Kentucky, Forente stater, 40202
- Kosair Children's Hospital
-
-
Michigan
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Detroit, Michigan, Forente stater, 48201
- Children's Hospital of Michigan, Wayne State University
-
-
North Carolina
-
Durham, North Carolina, Forente stater, 27705
- Duke University Medical Center
-
-
Texas
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Dallas, Texas, Forente stater, 75235
- University of Texas Southwestern Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tidsperspektiver: Retrospektiv
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
<26 weeks
Subjects <26 weeks gestational age
|
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
|
26-29 weeks
Subjects 26-29 weeks gestational age
|
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
|
30-32 weeks
Subjects 30-32 weeks gestational age
|
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
Drug prescribed per routine medical care.
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Danny Benjamin, MD, PPRU
- Hovedetterforsker: Mary Jayne Kennedy, Pharm, D, Louisville-PPRU
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Infeksjoner
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antibakterielle midler
- Antifungale midler
- Antiprotozoale midler
- Antiparasittiske midler
- Amebicider
- beta-laktamasehemmere
- Metronidazol
- Ampicillin
- Caspofungin
- Anidulafungin
- Amfotericin B
- Liposomal amfotericin B
- Piperacillin
- Acyclovir
- Tazobaktam
- Piperacillin, Tazobactam medikamentkombinasjon
Andre studie-ID-numre
- Pro00015379
- PPRU 10824 (Annen identifikator: Network Protocol Identifier)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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