Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study

NCT ID: NCT01975493

Last Updated: 2018-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

428 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2018-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Paediatric Antimicrobial Pharmacokinetics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

No interventions assigned to this group

Ampicillin

Group subdivided into age categories:

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

No interventions assigned to this group

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)

No interventions assigned to this group

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)

No interventions assigned to this group

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)

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Minute

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St George's, University of London

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mike Sharland, MD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Cornwall Hospitals NHS Trust

Truro, Cornwall, United Kingdom

Site Status

Taunton and Somerset NHS Foundation Trust

Taunton, Somerset, United Kingdom

Site Status

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, , United Kingdom

Site Status

Alder Hey Children's Hospital

Liverpool, , United Kingdom

Site Status

Liverpool Women's Hospital

Liverpool, , United Kingdom

Site Status

St George's Hospital

London, , United Kingdom

Site Status

Great Ormond Street Hospital

London, , United Kingdom

Site Status

John Radcliffe Hospital

Oxford, , United Kingdom

Site Status

Queen Alexandra Hospital

Portsmouth, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United Kingdom

Related Links

Access external resources that provide additional context or updates about the study.

http://www.grip-network.org/index.php/cms/en/home

Global Research in Paediatrics (GRiP)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-002366-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13/LO/0907

Identifier Type: OTHER

Identifier Source: secondary_id

13.0095

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.