TINN Pharmacokinetics (PK) Study Treat Infections iN Neonates
TINN-PK
Phase I, Open-label Study to Evaluate the Pharmacokinetics and Tolerability of Ciprofloxacin in Neonates With Suspected or Proven Gram Negative Infection
2 other identifiers
interventional
63
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2011
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 17, 2011
CompletedFirst Posted
Study publicly available on registry
March 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedOctober 12, 2015
October 1, 2015
1.8 years
March 17, 2011
October 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ciprofloxacin plasma concentration and population pharmacokinetic (PK) parameters
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
6 weeks
Secondary Outcomes (4)
PK variables
6 weeks
Tolerability
6 weeks
Safety
6 Weeks
Clinical/microbiological outcomes
6 Weeks
Study Arms (1)
Pharmacokinetics of ciprofloxacin
OTHERPatients receiving ciprofloxacin following clinical decision by attending physician
Interventions
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
Eligibility Criteria
You may qualify if:
- Receiving ciprofloxacin following clinical decision by attending physician
You may not qualify if:
- Likely not to survive 48 hours in the judgement of attending physician
- Ciprofloxacin commenced before 5th day of life
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liverpool Women's NHS Foundation Trustlead
- University of Liverpoolcollaborator
Study Sites (2)
Alder Hey Children's NHS Foundation Trust
Liverpool, Merseyside, L12 2AP, United Kingdom
Liverpool Women's NHS Foundation Trust
Liverpool, Merseyside, L8 7SS, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Mark A Turner, MD
University of Liverpool/Liverpool Women's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2011
First Posted
March 21, 2011
Study Start
January 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2013
Last Updated
October 12, 2015
Record last verified: 2015-10