Trial reportAntimicrobial agents and chemotherapy2014
Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design.
Trial report in Antimicrobial agents and chemotherapy, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 41 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.
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs
Who cites it
41 citing papers in PubMed, 69 citations in OpenAlex.
- Antibiotic Therapy for the Prevention and Treatment of Neonatal Sepsis.Clinics in perinatology · 2026Review
- Dexmedetomidine use in Infants undergoing Cooling due to neonatal Encephalopathy (DICE trial): safety and pharmacokinetics.Pediatric research · 2026Article
- Population pharmacokinetics and safety of continuous oxacillin in preterm and term neonates and infants.Antimicrobial agents and chemotherapy · 2026Article
- Evaluating the duration of post-discontinuation therapeutic ampicillin exposures in preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- Pharmacokinetics and Safety of Ustekinumab in Patients with Juvenile Psoriatic Arthritis: Results of the Real-World Ustekinumab Pediatric Opportunistic Pharmacokinetics Study (U-POPS).Rheumatology and therapy · 2026Article
- Creativity in Pediatric Clinical Pharmacology: Study Design and Oral Dosage Forms.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2024Article
- Phenotypic resistant single-cell characteristics under recurring ampicillin antibiotic exposure inmSystems · 2024Article
- CDC Guidelines for the Prevention and Treatment of Anthrax, 2023.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2023Article
- Cefotaxime/sulbactam plus gentamicin as a potential carbapenem- and amikacin-sparing first-line combination for neonatal sepsis in high ESBL prevalence settings.The Journal of antimicrobial chemotherapy · 2023Article
- Use of Antibiotics in Preterm Newborns.Antibiotics (Basel, Switzerland) · 2022Review
- Ampicillin dosing in premature infants for early-onset sepsis: exposure-driven efficacy, safety, and stewardship.Journal of perinatology : official journal of the California Perinatal Association · 2022Article
- Variation in ampicillin dosing for lower respiratory tract infections and neonatal bacterial infections in US children's hospitals.Antimicrobial stewardship & healthcare epidemiology : ASHE · 2022Article
- Knowledge gaps in late-onset neonatal sepsis in preterm neonates: a roadmap for future research.Pediatric research · 2022Review
- Pediatric AIDS-Therapeutic Successes Built on a Foundation of Pediatric Clinical Pharmacology with Pharmacokinetic-Pharmacodynamic Modeling.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2022Article
- Characterizing Pharmacokinetics in Children With Obesity-Physiological, Drug, Patient, and Methodological Considerations.Frontiers in pharmacology · 2022Review
- Developing a SWATH capillary LC-MS/MS method for simultaneous therapeutic drug monitoring and untargeted metabolomics analysis of neonatal plasma.Journal of chromatography. B, Analytical technologies in the biomedical and life sciences · 2021Article
- Prolonged Post-Discontinuation Antibiotic Exposure in Very Low Birth Weight Neonates at Risk for Early-Onset Sepsis.Journal of the Pediatric Infectious Diseases Society · 2021Article
- Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial): A Randomized Controlled Trial: Background, Aims and Study Protocol.Frontiers in pain research (Lausanne, Switzerland) · 2021Article
- Methodologic Progress Note: Opportunistic Sampling for Pharmacology Studies in Hospitalized Children.Journal of hospital medicine · 2021Article
- 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
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 8 institutions in 1 country.
Funding
Abstract
Although ampicillin is the most commonly used drug in neonates, developmental pharmacokinetic (PK) data to guide dosing are lacking. Ampicillin is primarily renally eliminated, and developmental changes are expected to influence PK. We conducted an open-label, multicenter, opportunistic, prospective PK study of ampicillin in neonates stratified by gestational age (GA) (≤ 34 or >34 weeks) and postnatal age (PNA) (≤ 7 or >7 days). Drug concentrations were measured by tandem mass spectrometry. PK data were analyzed using population nonlinear mixed-effects modeling in NONMEM 7.2. Monte Carlo simulations were conducted to determine the probability of target attainment for the time in which the total steady-state ampicillin concentrations remained above the MIC (T>MIC) for 50%, 75%, and 100% of the dosing interval. A total of 142 PK samples from 73 neonates were analyzed (median [range] GA, 36 [24 to 41] weeks; PNA, 5 [0 to 25] days). The median ampicillin dose was 200 (100 to 350) mg/kg/day. Postmenstrual age and serum creatinine were covariates for ampicillin clearance (CL). A simplified dosing regimen of 50 mg/kg every 12 h for GA of ≤ 34 weeks and PNA of ≤ 7 days, 75 mg/kg every 12 h for GA of ≤ 34 weeks and PNA of ≥ 8 and ≤ 28 days, and 50 mg/kg every 8 h for GA of >34 weeks and PNA of ≤ 28 days achieved the prespecified surrogate efficacy target in 90% of simulated subjects. Ampicillin CL was associated with neonatal development. A simplified dosing regimen stratified by GA and PNA achieves the desired surrogate therapeutic target in the vast majority of neonates.
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.