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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

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


Condition or disease Intervention/treatment Phase
Pharmacokinetics of Ciprofloxacin in Neonates Procedure: Collection of biological samples Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase I, Open-label Study to Evaluate the Pharmacokinetics and Tolerability of Ciprofloxacin in Neonates With Suspected or Proven Gram Negative Infection
Study Start Date : January 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Pharmacokinetics of ciprofloxacin
Patients receiving ciprofloxacin following clinical decision by attending physician
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





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. PK variables [ Time Frame: 6 weeks ]
    PK variables, including apparent volume of distribution and half life.

  2. Tolerability [ Time Frame: 6 weeks ]
    Withdrawal due to lack of tolerability

  3. Safety [ Time Frame: 6 Weeks ]
    Adverse events (AEs) and serious adverse events (SAEs).

  4. Clinical/microbiological outcomes [ Time Frame: 6 Weeks ]
    Outcome of treatment episodes (clinical and microbiological)



Information from the National Library of Medicine

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Ages Eligible for Study:   24 Weeks to 52 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319435


Locations
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United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, Merseyside, United Kingdom, L12 2AP
Liverpool Women's NHS Foundation Trust
Liverpool, Merseyside, United Kingdom, L8 7SS
Sponsors and Collaborators
Liverpool Women's NHS Foundation Trust
University of Liverpool
Investigators
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Principal Investigator: Mark A Turner, MD University of Liverpool/Liverpool Women's Hospital
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Responsible Party: Liverpool Women's NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01319435    
Other Study ID Numbers: LWH0852
2010-019955-23 ( EudraCT Number )
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: October 2015
Keywords provided by Liverpool Women's NHS Foundation Trust:
Ciprofloxacin
Neonates
Gram negative infection
Additional relevant MeSH terms:
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Infection