Related Experiment Video
Updated: Jun 7, 2026

How to Administer Near-Infrared Spectroscopy in Critically ill Neonates, Infants, and Children
Published on: August 19, 2020
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.
Background:
ciprofloxacin has no marketing authorization for use in neonates worldwide but it is prescribed for the treatment of neonatal life-threatening infections, mainly in developing countries and in Europe. Given the concerns about its toxicity in this population and the necessity for its use in specific clinical situations, we conducted a systematic review of the use of ciprofloxacin in neonates.
Methods:
we performed a systematic search of PubMed, Embase, and the Cochrane Database of Systematic Reviews and bibliographies of relevant articles. We included all studies, regardless of design, that reported efficacy, safety, and pharmacokinetics of ciprofloxacin for the treatment of any neonatal infectious condition. We excluded letters, editorials, preliminary reports, and abstracts.
Results:
observational cohort studies, case reports, and descriptions of patient series account for all literature reviewed. Ciprofloxacin was administrated in neonates as a salvage therapy for sepsis due to multidrug-resistant strains or with signs of clinical deterioration under first-line antibiotic treatment. Initial administration was always intravenous with variable dosing schedule. Clinical response to treatment was estimated at 64% and 91% in 2 cohort studies, with a median of 83% in case series. Of the 14 case reports, 12 yielded positive clinical outcomes. No serious adverse events, particularly joint toxicity, were observed, although evaluation was predominantly clinical and follow-up limited to few months after the end of treatment.
Conclusions:
the current literature provides some information to support the use of ciprofloxacin in neonates. Additional high quality studies should be undertaken to provide reliable data on pharmacokinetics, efficacy, and long-term safety.
Related Concept Videos
Drug Dosing: Infants and Children
Inhibitors of Bacterial DNA Synthesis
Pharmacokinetics in Pediatric Patients: Drug Excretion
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
Pharmacokinetics in Pediatric Patients: Drug Metabolism
Pharmacokinetics in Pediatric Patients: Drug Distribution

