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TINN Pharmacokinetics (PK) Study Treat Infections iN Neonates (TINN-PK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01319435
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : October 12, 2015
Sponsor:
Collaborator:
University of Liverpool
Information provided by (Responsible Party):
Liverpool Women's NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE March 17, 2011
First Posted Date  ICMJE March 21, 2011
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE January 2011
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2011)
Ciprofloxacin plasma concentration and population pharmacokinetic (PK) parameters [ Time Frame: 6 weeks ]
Ciprofloxacin plasma concentration and population pharmacokinetic (PK) parameters [maximum concentration, clearance, area under the curve (0-tau)], their relationship with selected covariates their interindividual variability (CV%). Covariate analysis will include postmenstrual age, gestational age, postnatal age, weight, and serum creatinine
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2011)
  • PK variables [ Time Frame: 6 weeks ]
    PK variables, including apparent volume of distribution and half life.
  • Tolerability [ Time Frame: 6 weeks ]
    Withdrawal due to lack of tolerability
  • Safety [ Time Frame: 6 Weeks ]
    Adverse events (AEs) and serious adverse events (SAEs).
  • Clinical/microbiological outcomes [ Time Frame: 6 Weeks ]
    Outcome of treatment episodes (clinical and microbiological)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TINN Pharmacokinetics (PK) Study Treat Infections iN Neonates
Official Title  ICMJE Phase I, Open-label Study to Evaluate the Pharmacokinetics and Tolerability of Ciprofloxacin in Neonates With Suspected or Proven Gram Negative Infection
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pharmacokinetics of Ciprofloxacin in Neonates
Intervention  ICMJE Procedure: Collection of biological samples

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

Study Arms  ICMJE Pharmacokinetics of ciprofloxacin
Patients receiving ciprofloxacin following clinical decision by attending physician
Intervention: Procedure: Collection of biological samples
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2015)
63
Original Estimated Enrollment  ICMJE
 (submitted: March 18, 2011)
50
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Receiving ciprofloxacin following clinical decision by attending physician

Exclusion Criteria:

  • Likely not to survive 48 hours in the judgement of attending physician
  • Ciprofloxacin commenced before 5th day of life
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Weeks to 52 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01319435
Other Study ID Numbers  ICMJE LWH0852
2010-019955-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liverpool Women's NHS Foundation Trust
Study Sponsor  ICMJE Liverpool Women's NHS Foundation Trust
Collaborators  ICMJE University of Liverpool
Investigators  ICMJE
Principal Investigator: Mark A Turner, MD University of Liverpool/Liverpool Women's Hospital
PRS Account Liverpool Women's NHS Foundation Trust
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP