Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study (NAPPA)

• ClinicalTrials.gov Identifier: NCT01975493
• Recruitment Status: Unknown
• First Posted: November 3, 2013
• Last Update Posted: March 21, 2018
• Sponsor: St George's, University of London
• Information provided by (Responsible Party): St George's, University of London

Tracking Information

• First Submitted Date: September 23, 2013
• First Posted Date: November 3, 2013
• Last Update Posted Date: March 21, 2018
• Study Start Date: November 2013
• Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 28, 2013): The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin. [ Time Frame: Participants will be followed for the duration of enrolment, an expected average of 7 days. ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
• Official Title: Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
• Brief Summary: The aim of NAPPA is to develop new models to improve our understanding of how children process ('metabolise') penicillins, to help us discover if we can improve the dosing regimens used for children in the future. The study population will involve children and neonates who need a penicillin antibiotic as part of their normal National Health Service (NHS) care, and who also need blood tests or intravenous access. Therefore the antibiotic study can be done without the need for any extra invasive procedures, and there will be no change to the medication therapy received by participants. In addition, NAPPA will evaluate whether it is feasible to measure antibiotic levels on a tiny drop of blood put onto absorbent paper ("dried blood spot"). This allows the sample to be stored and tested later on. NAPPA will compare the level of the antibiotic using this method with the level measured in the usual way, to show if this is a reliable method that could be used routinely in the future.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided

Biospecimen

Retention:   Samples With DNA

Description:

Plasma samples and dried blood spots to be retained for retrospective analysis.

• Sampling Method: Non-Probability Sample
• Study Population: Children (aged under 16 years) and infants (including both full-term and premature neonates), admitted to hospital and routinely prescribed one (or more) of the study penicillins according to local hospital policy.
• Condition: Paediatric Antimicrobial Pharmacokinetics
• Intervention: Not Provided

Study Groups/Cohorts

• Amoxicillin

  Group subdivided into age categories:

  Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)

• Ampicillin

  Group subdivided into age categories:

  Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months)

• Benzylpenicillin

  Group subdivided into age categories:

  Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)

• Co-amoxiclav

  Group subdivided into age categories:

  Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)

• Flucloxacillin

  Group subdivided into age categories:

  Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)

• Piperacillin/tazobactam

  Group subdivided into age categories:

  Preterm newborn infants Term newborn infants (0-27 days) Infants and toddlers (1 month to 23 months) Children (2 - 11 years) Adolescents (12 - 16 years)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: April 1, 2016): 428
• Original Estimated Enrollment (submitted: October 28, 2013): 600
• Estimated Study Completion Date: June 2018
• Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Child aged under 16 years receiving one of the specified penicillins and with intravenous access or blood test(s) as part of their routine clinical care.
• Informed consent form signed by parent or legal guardian.

Exclusion Criteria:

• Any child or infant unlikely to survive 48 hours after recruitment.
• Patient known to be pregnant.
• Known allergy or hypersensitivity to beta-lactam antibiotics (including penicillins and cephalosporins) or beta-lactamase inhibitors.
• Patient receiving (or planned to receive) haemofiltration, haemodialysis, peritoneal dialysis, extracorporeal membrane oxygenation (ECMO) or cardiopulmonary bypass.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 1 Minute to 15 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT01975493
• Other Study ID Numbers: 13.0095; 2013-002366-40 ( EudraCT Number ); 13/LO/0907 ( Other Identifier: Research Ethics Committee (REC) )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: St George's, University of London
• Original Responsible Party: Same as current
• Current Study Sponsor: St George's, University of London
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mike Sharland, MD; St George's, University of London

• PRS Account: St George's, University of London
• Verification Date: March 2018