TINN Pharmacokinetics (PK) Study Treat Infections iN Neonates
Condition: Pharmacokinetics of Ciprofloxacin in Neonates
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, open-label study to evaluate the pharmacokinetics, tolerability and short-term
      safety of ciprofloxacin in neonates with suspected (or proven) Gram Negative infection.
      Objectives: To evaluate the multiple-dose pharmacokinetics of ciprofloxacin in neonates and
      young infants (24 - 52 weeks postmenstrual age) with suspected or proven Gram Negative
      infection.

      To evaluate the tolerability and describe short-term safety of ciprofloxacin in neonates and
      young infants with suspected (or proven) Gram Negative infection.

      To describe the clinical outcomes of neonates treated with ciprofloxacin
    

Detailed description: 
      This study is part of TINN 'Treat Infections in Neonates' a comprehensive project that is
      evaluating the safety of ciprofloxacin and how it is tolerated by neonates. Ciprofloxacin is
      an antibiotic that has been used for many years in newborn babies and infants less than 3
      months old to treat bacteria that are resistant to other antibiotics. Ciprofloxacin is
      unlicensed for this age group. The European Medicines Agency and WHO have prioritised
      research about this drug. The TINN consortium aims to conduct the work required for a license
      (marketing authorization) in newborn babies and infants less than 3 months old. The aim of
      this study is to describe how newborn babies and young infants deal with this medicine. Blood
      samples will be taken at the beginning of the course of antibiotics and at the end. A minimal
      amount of blood will be required (less than half a teaspoon) in total and collected by staff
      experienced in blood sampling from neonates in a way that causes the least disruption to the
      baby. The levels of ciprofloxacin in the blood will be measured. The levels will be used to
      work out how quickly the body gets rid of the medicine. This will allow recommendations about
      the best dose and how often the medicine should be given.

      We aim to recruit 50 neonates and infants under the age of 3 months who have been prescribed
      Ciprofloxacin as inpatients for suspected or proven infection. They will be recruited over 2
      years from the neonatal unit at Liverpool Women's NHS Foundation Trust and Alder Hey
      Children's NHS Foundation Trust. Consent will be requested for babies to have more detailed
      investigation to see if there if genetic factors affect the way the body handles
      ciprofloxacin.
    

Intervention name(s): Collection of biological samples
Intervention type(s): Procedure
Intervention description(s): Sparse blood samples (n=2 or 3 depending on weight) will be drawn on day 1 and day 5- 7 (or last day of treatment if the course is completed before day 7).
Monitoring of adverse events DNA for pharmacogenetics (scavenged clinical samples or buccal) CSF (if required clinically) Faeces
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ciprofloxacin; Neonates; Gram negative infection