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ARTIC PC - Antibiotics for lower Respiratory Tract Infection in Children presenting in Primary Care

ARTIC PC processes

Artic PC study
Artic PC study

Aims and objectives - what we are going to do and how we will do it and important information about processes.

 

Aims & objectives

We do not know on what basis would they give or deny antibiotics to a child that was coughing up productive sputum, had a fever, some SOB, or some coarse chest crepitations - this is an evidence free zone i.e. there is no evidence to help inform the decision, which is where ARTIC PC is trying to help.

Our aim is to provide evidence to inform the management of chest infections in children. The objectives are:

• To estimate the effectiveness of amoxicillin overall and in key clinical subgroups of children presenting with uncomplicated (non-pneumonic) lower respiratory tract infection in primary care.

• To estimate the cost-effectiveness of antibiotics overall and in key clinical subgroups of children presenting with uncomplicated lower respiratory tract infection in primary care.

• To explore the estimates of effectiveness according to key pathophysiological subgroups (the presence of bacterial pathogens; raised C reactive protein measurement or white cell count; the presence of clinically undetected consolidation on X ray; oximetry; lung function).

• To develop prediction models to detect pneumonia in children and children at risk for complications (abnormal course of disease, hospital referral).

 

How can I get involved? (For the public)

What would it mean?

We are asking you to spend an additional 30 minutes or so at the surgery on the day of recruitment to complete a history of your child’s illness and some basic personal data like their Date of Birth and the number of children at home. If you are willing you can consent to the *optional tests of a throat swab, a finger prick blood test and a chest x-ray.

These samples, if you are willing, will be kept for future research into infectious diseases. This will allow us and/or other researchers to do further work on them in the future. Research for which they might be used could, for example, involve looking at other types of bugs or the importance of genes to work out how the immune system responds to infection. No information that could be used to identify your child will be given to researchers using the samples. Neither the samples nor anything in them or any information related to them will be sold or used to make money. You will be able to say on the consent form whether you would be happy for your samples to be kept and used in this way or not.

The x-ray would ideally be within 3 days of recruitment and a hospital local to you. We can pay reasonable travel expenses for this.

*You do not need to agree to any of these tests in order to take part in this study.

If you are willing and the doctor or nurse thinks it safe for you to help (this means - for example- your child does not have an allergy to the study medicine nor do they have pneumonia)we  will enrol you in the trial study,  which means you having either an antibiotic called amoxicillin or a placebo -dummy medicine. The treatment you have is decided by chance like tossing a coin. No-one of will know which treatment they have received until the end of the project. This is what is called a Randomised Controlled Trial (RCT). The trial will provide the best research evidence.

The other part of the project is called an observational study. This is where you have the treatment the doctor or nurse would usually give you but you also complete the diary and have the option of providing any of, or none of, the throat swab, finger prick blood test and x-ray.

We need you to complete a symptom diary that will take about 5 minutes a day to be completed for up to 28 days or until your child is well again- if this is less than 28 days. The diary is posted back to us in a free post envelope.

At the end of the 28 days we will ask you to return to the surgery taking the diary if you have not returned it and if your child is over 6 years old undertake breath test to look at the functioning of their lungs.

We will ask your permission to look at your child’s medical notes at a later date for any return appointment within the 28 days of the project for any other chest problems.

We will be asking parents, and children where they are old enough to help, if they are willing to be interviewed about their experiences of helping us. These are most likely to be undertaken by telephone at a time convenient to you.

As a thank you for your time and help we offer a high street voucher.

If you would like to know more contact us.

 

 

How can I get involved? (For primary care sites) Also see the flow diagram in our 'Useful downloads' section below.

What would it mean?

The following lists what we would expect you to do, there is also a flow diagram showing this in our useful downloads section.

• Screening log completed for all potentially eligible patients.

• Completing the daily (Monday – Friday) drug temperature log.

Day 1

• Receive Consent and possibly assent.

• CRF 1 (on line or on paper and transfer to on-line ASAP after recruitment)

• Instruct on diary completion.

• Weigh child to calculate dose of IMP if in trial (see dosing schedule).

• Provide IMP if in trial and sign log (countersignature voluntary)

• Instruct in storage of reconstituted medicine (in bag).

• If consented

- Take blood sample. Note on ARTIC PC on-line database.

- Take throat swab. Note on ARTIC PC on-line database.

- Refer to radiology. Note on ARTIC PC on-line database.

• Give child sticker and certificate.

• Note on recruitment pack if used and if will need Spirometry at day 28.

• Make day 28 appointment.

Day 28

• Collect unused IMP. Estimate IMP usage.

• Collect diary (ask to post back if not given) or complete replacement pro forma.

• Perform Spirometry or Peak Flow Expiratory Rate if child >6 years, transfer to on-line ASAP after recruitment.

If you are interested please contact us and we can see if your region is already helping and who your contact is.

Reimbursement
Reimbursement is mainly by Research Costs, payable on completion of elements of the project. If all supporting Clinical Research Networks agree the Service Support Costs and all elements are completed the study will provide a reimbursement of about £100 per child, the trial about £140 per child.

Our database for data entry is hosted by the Julius Centre in Utrecht who we have worked with many times before. 

The dummy database can be accessed via the Web site https://researchonline.org/

This works best in the web browsers of Chrome or Firefox.

Use the Username: ARTICtest1

And Password: ARTICtest1

If you would like to help please use the contact us page.

 

 

Please take a moment to view our YouTube videos providing useful information from Research Staff involved in the project.

 

ARTIC PC Training video Rationale for undertaking ARTIC-PC

 

ARTIC PC Training Video Successful recruitment approach

 

ARTIC PC Successful recruitment approach 2

 

ARTIC PC Study document and sample taking

Processes - for a flow diagram of recruitment please see our 'Useful downloads' section below.

Discontinuation / withdrawal of participants from trial

Each participant has the right to discontinue their study medication or withdraw from the study at any time. In addition, the investigator may discontinue a participant’s study medication or withdraw a participant from the study at any time if the investigator considers it necessary (e.g. the participant experiences an adverse drug reaction, the participant’s parent or guardian withdraws consent, or the investigator considers that further participation in the study would not be appropriate due to the personal circumstances of the participant or the participant’s parent or guardian).

Discontinuation of study medication

Clinicians will be advised to discontinue a participant’s study medication if he/she experiences an adverse drug reaction related to the study medication. In addition, clinicians will be advised to prescribe an appropriate non beta-lactam antibiotic if antibiotic treatment is indicated. Parents/guardians of participants whose study medication is discontinued will still be required to complete their study diaries and questionnaires and will still receive telephone follow-up calls unless they choose to withdraw consent for these.

Withdrawal

Once a participant withdraws or is withdrawn from the study, no actions will be taken to obtain data other than to monitor adverse events. Consent to proceed with reviewing the medical notes will be specifically confirmed for participants withdrawn from the study.

Unblinding and Adverse Events processes

Unblinding

Every recruit in the RCT will be given an unblinding card at recruitment containing their start date of the trial, the Medicine ID, a local contact telephone number and the unblinding telephone number.

Unblinding is available 24 hours a day 7 days a week via the telephone number 0031 88 75 67999, please have the Medicine ID (found on the medicine bottle and / or unblinding card) available.

We do not expect unblinding to be common. Unblinding can occur if requested by clinicians for clinical reasons – for example where adverse events occurred (e.g. anaphylaxis, admission to hospital with life threatening illness (e.g. septicaemia; meningitis; severe pneumonia requiring ICU admission) and death).

Clinical deterioration will not necessarily require unblinding but a prescription of a non-beta lactam antibiotic is advised.

Adverse Events

We would prefer the reporting of these to be on line as then we have an email alert. If you use paper copy (provided at set up) please alert the project team by email artic-pc@soton.ac.uk or by fax 023 8000 2380.

Amoxicillin is a licensed medicine whose most common side-effects are mucocutaneous candidosis (thrush), diarrhoea, nausea, vomiting and rash (occurrence >=1/100 to <1/10). If these occur and are non-serious and of mild to moderate severity (based on clinician’s assessment) an Adverse Event Report form will not be necessary. We will collect data on events such as severe reactions to the antibiotics such as anaphylaxis, severe allergy requiring steroid administration, emergency hospitalization for chest problems and severe Clostridium (antibiotic related diarrhoea).

Unexpected adverse reactions to beta-lactam antibiotics will be highly unlikely amongst trial participants, as the vast majority of children will have previously received beta-lactams to treat other infections. For non-serious adverse reactions to trial medication, the Chief Investigator or a designated alternative study clinician will assess the urgency with which the participant’s treatment allocation should be unblinded.

Useful Downloads

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Useful Downloads

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Useful Downloads

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Useful Downloads

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