Evidence map›Paper›PMID 38062257›Full record

ArticlePediatric research2024

Population pharmacokinetics of ciprofloxacin in newborns with early onset neonatal sepsis and suspected meningitis.

Kunal Garg, Ritika Kondel Bhandari, Nusrat Shafiq, Suksham Jain, Shivani Jaswal, Deepak Chawla, Surulivelrajan Mallayasamy, Supreet Khurana, Jaya Shree Dilli Batcha

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Article in Pediatric research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.5field-weighted citation impact, top 31% of its field
1 · What the graph read from it

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 1 country.

Kunal GargDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, India.
Ritika Kondel BhandariDepartment of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Nusrat ShafiqDepartment of Pharmacology, Post Graduate Institute of Medical Education and Research, Chandigarh, India.
Suksham JainDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, India.
Shivani JaswalDepartment of Biochemistry, Government Medical College and Hospital, Chandigarh, India.
Deepak ChawlaDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, India.
Surulivelrajan MallayasamyDepartment of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Supreet KhuranaDepartment of Neonatology, Government Medical College and Hospital, Chandigarh, India. supreetkhurana85@gmail.com.
Jaya Shree Dilli BatchaDepartment of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, Karnataka, India.
Government Medical College and Hospital · INManipal Academy of Higher Education · INPost Graduate Institute of Medical Education and Research · INGovernment Medical College and Hospital · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeonatal Sepsis accounts for significant proportion of neonatal mortality globally. Ciprofloxacin can be used as an effective antimicrobial against common causative agents of neonatal sepsis. However, there is only limited information about its pharmacokinetic distribution in plasma and Cerebrospinal fluid (CSF) of neonates.

methodsPlasma and CSF samples were taken using a sparse sampling technique from neonates who received at least one dose of intravenous ciprofloxacin. Ciprofloxacin levels were analysed using high-performance liquid chromatography (HPLC). Population pharmacokinetic analysis was conducted using a non-linear mixed-effects modelling using Pumas® (Pharmaceutical Modelling and Simulation) package (Version 2.0).

results53 neonates were enroled in the study of whom; 9 (17%) had meningitis. The median concentration of ciprofloxacin in CSF was 1.4 (0.94-2.06) ug/ml and plasma was 2.94 (1.8-5.0) ug/ml. A one-compartment model with first-order elimination fitted the data. Body weight was found to be a significant covariate on volume of distribution (Vd). Simulations based on the final model suggest that dose of 10 mg/kg, intravenous b.d may not be able to achieve the desirable indices.

conclusionsOne compartment model with weight as a covariate explained the available data. Further studies with modified sampling strategy, larger sample size and variable dose levels are needed.

Indexed as

Anti-Bacterial AgentsCiprofloxacinNeonatal SepsisAdministration, IntravenousChromatography, High Pressure LiquidFemaleHumansInfant, NewbornMaleMeningitisModels, BiologicalAnti-Bacterial AgentsCiprofloxacin

Identifiers

PMID38062257
OpenAlexW4389429229

What OpenQuestion holds

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Registered trials

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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.