Trial reportThe Pediatric infectious disease journal2013
Determining population and developmental pharmacokinetics of metronidazole using plasma and dried blood spot samples from premature infants.
Trial report in The Pediatric infectious disease journal, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01222585 (Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants), which is not on this map. Cited by 25 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Safety and Pharmacokinetics of Multiple Dose Metronidazole in Premature Infants
Who cites it
25 citing papers in PubMed, 51 citations in OpenAlex.
- Metronidazole exposure-response and safety in infants.Antimicrobial agents and chemotherapy · 2025Trial
- Intestinal fatty-acid binding protein and metronidazole response in premature infants.Journal of neonatal-perinatal medicine · 2014Trial
- Evaluation and optimization of sample size of neonates and infants for pediatric clinical studies on cefiderocol using a model-based approach.Pharmacology research & perspectives · 2024Article
- Opportunistic dried blood spot sampling validates and optimizes a pediatric population pharmacokinetic model of metronidazole.Antimicrobial agents and chemotherapy · 2024Article
- Dried Blood Spots-A Platform for Therapeutic Drug Monitoring (TDM) and Drug/Disease Response Monitoring (DRM).European journal of drug metabolism and pharmacokinetics · 2023Review
- Developmental Pharmacokinetics of Antibiotics Used in Neonatal ICU: Focus on Preterm Infants.Biomedicines · 2023Review
- An Innovative Approach to Building an Effective and Efficient Pediatric Trial Network.Hospital pediatrics · 2022Article
- Fabrication and In Vitro/In Vivo Appraisal of Metronidazole Intra-Gastric Buoyant Sustained-Release Tablets in Healthy Volunteers.Pharmaceutics · 2022Article
- Infection control and other stewardship strategies in late onset sepsis, necrotizing enterocolitis, and localized infection in the neonatal intensive care unit.Seminars in perinatology · 2020Article
- A Dried Blood Spot Analysis for Solithromycin in Adolescents, Children, and Infants: A Short Communication.Therapeutic drug monitoring · 2019Article
- Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates.Therapeutic drug monitoring · 2018Article
- Dosing antibiotics in neonates: review of the pharmacokinetic data.Future microbiology · 2017Article
- Prediction of serum theophylline concentrations and cytochrome P450 1A2 activity by analyzing urinary metabolites in preterm infants.British journal of clinical pharmacology · 2017Article
- Metronidazole Metabolism in Neonates and the Interplay Between Ontogeny and Genetic Variation.Journal of clinical pharmacology · 2017Article
- Development of Floating-Mucoadhesive Microsphere for Site Specific Release of Metronidazole.Advanced pharmaceutical bulletin · 2016Article
- Solithromycin Pharmacokinetics in Plasma and Dried Blood Spots and Safety in Adolescents.Antimicrobial agents and chemotherapy · 2016Article
- Adverse consequences of neonatal antibiotic exposure.Current opinion in pediatrics · 2016Review
- Optimizing operational efficiencies in early phase trials: The Pediatric Trials Network experience.Contemporary clinical trials · 2016Article
- Clinical trials of medicines in neonates: the influence of ethical and practical issues on design and conduct.British journal of clinical pharmacology · 2015Review
- New antibiotic dosing in infants.Clinics in perinatology · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 6 institutions in 1 country.
Funding
Abstract
backgroundLimited pharmacokinetic (PK) data of metronidazole in premature infants have led to various dosing recommendations. Surrogate efficacy targets for metronidazole are ill-defined and therefore aimed to exceed minimum inhibitory concentration of organisms responsible for intra-abdominal infections.
methodsWe evaluated the PK of metronidazole using plasma and dried blood spot samples from infants ≤32 weeks gestational age in an open-label, PK, multicenter (N = 3) study using population PK modeling (NONMEM). Monte Carlo simulations (N = 1000 virtual subjects) were used to evaluate the surrogate efficacy target. Metabolic ratios of parent and metabolite were calculated.
resultsTwenty-four premature infants (111 plasma and 51 dried blood spot samples) were enrolled: median (range) gestational age at birth 25 (23-31) weeks, postnatal age 27 (1-82) days, postmenstrual age 31 (24-39) weeks and weight 740 (431-1466) g. Population clearance (L/h/kg) was 0.038 × (postmenstrual age/30) and volume of distribution (L/kg) of 0.93. PK parameter estimates and precision were similar between plasma and dried blood spot samples. Metabolic ratios correlated with clearance.
conclusionSimulations suggested the majority of infants in the neonatal intensive care unit (>80%) would meet the surrogate efficacy target using postmenstrual age-based dosing.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.