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Intestinal fatty-acid binding protein and metronidazole response in premature infants
M R Sampson1, B T Bloom2, A Arrieta3
1Duke Clinical Research Institute, Durham, NC, USA UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA.
Insights
Urinary intestinal fatty acid-binding protein (I-FABP) may indicate treatment response in premature infants with abdominal infections. In infants with necrotic gastrointestinal disease, I-FABP levels correlated with metronidazole exposure, suggesting its potential as a biomarker.
Area of Science:
- Neonatal medicine
- Pharmacokinetics
- Biomarker research
Background:
- Biomarkers for treatment response to antimicrobial therapy are needed in premature infants with suspected intra-abdominal infection.
- Intestinal fatty acid-binding protein (I-FABP) is released during intestinal mucosal injury and has not been evaluated as a disease response marker.
- This study investigated I-FABP as a potential surrogate marker for antimicrobial treatment efficacy.
Purpose of the Study:
- To examine the relationship between metronidazole exposure and urinary I-FABP concentrations in premature infants with suspected intra-abdominal infection.
- To evaluate I-FABP as a potential pharmacodynamic surrogate marker for treatment response.
- To explore factors influencing I-FABP levels during antimicrobial therapy.
Main Methods:
- Conducted an intravenous metronidazole pharmacokinetic study in premature infants.
- Collected up to three urine samples per infant for I-FABP concentration measurements.
- Analyzed the relationship between I-FABP concentrations and metronidazole exposure, pharmacokinetics, and other covariates.
Main Results:
- Twenty-six samples from 19 premature infants were analyzed during metronidazole treatment.
- No significant associations were found between predictor variables and I-FABP when all samples were considered.
- A significant association was observed between average predicted metronidazole concentration and I-FABP concentration in infants with necrotic gastrointestinal disease (p = 0.006).
Conclusions:
- Urinary I-FABP shows potential as a pharmacodynamic surrogate for antimicrobial treatment of serious abdominal infections in neonates and infants.
- While a direct predictive association was not universally observed, the findings in a specific subgroup are promising.
- Further research is warranted to validate I-FABP's role in guiding antimicrobial therapy in this population.
Objectives:
In premature infants with suspected intra-abdominal infection, biomarkers for treatment response to antimicrobial therapy are lacking. Intestinal fatty acid-binding protein (I-FABP) is specific to the enterocyte and is released in response to intestinal mucosal injury. I-FABP has not been evaluated as a surrogate marker of disease response to antimicrobial therapy. We examined the relationship between metronidazole exposure and urinary I-FABP concentrations in premature infants with suspected intra-abdominal infection.
Study Design:
We conducted an intravenous metronidazole pharmacokinetic study, collecting ≤3 urine samples per infant for I-FABP concentration measurements. We analyzed the relationship between I-FABP concentrations and measures of metronidazole exposure and pharmacokinetics, maturational factors, and other covariates.
Results:
Twenty-six samples from 19 premature infants were obtained during metronidazole treatment. When analyzed without regard to presence of necrotic gastrointestinal disease, there were no significant associations between predictor variables and I-FABP concentrations. However, when the sample was limited to premature infants with necrotic gastrointestinal disease, an association was found between average predicted metronidazole concentration and I-FABP concentration (p = 0.006).
Conclusion:
While a predictive association between urinary I-FABP and metronidazole systemic exposure was not observed, the data suggest the potential of this endogenous biomarker to serve as a pharmacodynamic surrogate for antimicrobial treatment of serious abdominal infections in neonates and infants.
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