Ciprofloxacin use in neonates: a systematic review of the literature

Florentia Kaguelidou1, Mark A Turner, Imti Choonara

  • 1Department of Pediatric Pharmacology and Pharmacogenetics, Hôpital Robert Debré, APHP; INSERM CIC9202; Université Paris 7, Paris, France.

Insights

Ciprofloxacin shows potential for treating neonatal infections, particularly multidrug-resistant sepsis, with a reported clinical response rate of 83% and no observed serious adverse events. Further high-quality studies are needed to confirm its safety and efficacy in neonates.

Area of Science:

  • Neonatal pharmacology
  • Infectious disease management
  • Antibiotic stewardship

Background:

  • Ciprofloxacin lacks marketing authorization for neonates globally but is used for life-threatening infections, especially in developing countries and Europe.
  • Concerns regarding ciprofloxacin's toxicity in neonates necessitate a thorough review of its use.
  • This systematic review addresses the clinical utility of ciprofloxacin in neonatal populations.

Purpose of the Study:

  • To systematically review the existing literature on the efficacy, safety, and pharmacokinetics of ciprofloxacin in treating neonatal infections.
  • To evaluate the clinical outcomes and adverse events associated with ciprofloxacin use in neonates.
  • To identify gaps in knowledge and recommend future research directions.

Main Methods:

  • A systematic search was conducted across PubMed, Embase, and the Cochrane Database of Systematic Reviews.
  • Studies of any design reporting efficacy, safety, or pharmacokinetics of ciprofloxacin in neonates were included.
  • Letters, editorials, preliminary reports, and abstracts were excluded.

Main Results:

  • The literature primarily consists of observational cohort studies, case reports, and patient series.
  • Ciprofloxacin was used as salvage therapy for sepsis in neonates with multidrug-resistant strains or deteriorating clinical status.
  • Reported clinical response rates ranged from 64% to 91% in cohort studies and a median of 83% in case series; no serious adverse events were noted, though follow-up was limited.

Conclusions:

  • Existing literature offers some support for the use of ciprofloxacin in neonates.
  • Further high-quality research is essential to establish reliable data on pharmacokinetics, efficacy, and long-term safety.
  • The findings highlight the need for evidence-based guidelines for ciprofloxacin use in neonatal critical care settings.
Abstract

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