Paediatric Antimicrobial PharmacokineticsNAPPANCT01975493
Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
An observational study of Paediatric Antimicrobial Pharmacokinetics, run by St George's, University of London at 9 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 minute to 15 years
- Conditions the study is for
- Paediatric Antimicrobial Pharmacokinetics
- How many people
- 428 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Nov 2013to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, CV2 2DX
Alder Hey Children's Hospital
Liverpool, L12 2AP
Liverpool Women's Hospital
Liverpool, L8 7SS
St George's Hospital
London, SW17 0QT
Great Ormond Street Hospital
London, WC1N 3JH
John Radcliffe Hospital
Oxford, OX3 9DU
Queen Alexandra Hospital
Portsmouth, PO6 3LY
Taunton and Somerset NHS Foundation Trust
Taunton, Somerset, TA1 5DA
Royal Cornwall Hospitals NHS Trust
Truro, Cornwall, TR1 3LJ
About this study
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.
- Keywords
- Infectious Diseases, Paediatrics, Neonatology, Pharmacokinetics, Antimicrobials
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetic parameters of drug clearance and volume of distribution for each penicillin.
Measured: Participants will be followed for the duration of enrolment, an expected average of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paediatric Antimicrobial PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 428 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mike Sharland, MD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01975493
- Sponsor's protocol ID
- 13.0095
- Other IDs
- 2013-002366-40, 13/LO/0907
- Acronym
- NAPPA
- Status last verified
- Mar 2018
- First submitted
- 23 Sep 2013
- Last updated
- 21 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal and Paediatric Pharmacokinetics of Antimicrobials Study
- ClinicalTrials.gov ID
- NCT01975493
- Acronym / sponsor ID
- NAPPA / 13.0095
- Keywords
- Infectious Diseases, Paediatrics, Neonatology, Pharmacokinetics, Antimicrobials
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 428 participants (actual)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 4 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 1 minute to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2018.
- Global Research in Paediatrics (GRiP)Link provided by the sponsor.
Related trials for Paediatric Antimicrobial Pharmacokinetics
RecruitingObservational study
Tissue Penetration of Antibiotics in CriTically Ill Children
Pediatric Critical Illness, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Sharland, MD principal investigator
St George's, University of London
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paediatric Antimicrobial Pharmacokinetics, run by St George's, University of London at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2018.