2012 10 12 participant information sheet v2_0


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2012 10 12 participant information sheet v2_0

  1. 1. ChildRen with Eczema, Antibiotic Management Study CREAM Information Sheet for Parents & GuardiansYour doctor or nurse has invited your child to take part in this medical study. Before you decide if you want yourchild to take part, please carefully read this information sheet.Why do we want to do the study?Eczema is a common condition, especially in young children. We know that people with eczema frequently havea bacteria called Staphylococcus aureus (S. aureus) on their skin. S. aureus can sometimes cause an obviousskin infection that needs treatment with antibiotics, but is often present without any signs of infection. Eczemasometimes gets worse, or ‘flares’, and having this bacterium on the skin may contribute to causing some ofthese flares. However, we do not know whether a child with a flare of eczema, that a GP or nurse believesmay be triggered by infection, will benefit from additional treatment with antibiotics. We also do not knowif taking an antibiotic by mouth (oral) or using an antibiotic cream on the skin (topical) might be better.We want to answer these questions by testing the use of oral antibiotics (flucloxacillin or erythromycin if allergicto penicillin) and a topical antibiotic (fusidic acid) in a research study. The study will be based in Wales,Scotland and England.Why has my child been asked to take part?Your child’s general practitioner (GP) or practice nurse thinks that your child’s eczema may be infected, and hasidentified that they could be eligible for the CREAM study.What happens if he/she takes part? While you are at your GP surgery: If you agree to consider having your child take part in the study your GP or practice nurse will ask you for permission to send your contact details and some basic clinical information including whether your child is allergic to penicillin to the research team. A research nurse will then call you to arrange a convenient time to see you and your child at home. At the first visit (baseline):  The research nurse will ask you some questions to see if your child is suitable for the study.  If your child is suitable, and you are happy for them to take part, the research nurse will ask you to sign a consent form. If you are happy to go ahead, the research nurse will provide you with oral medicine (for your child to take by mouth) and topical medicine (to be applied to your child’s skin) to be used over the next week.  Your child will be assigned at random to receive one of the following three treatments: an oral antibiotic (flucloxacillin or erythromycin if allergic to penicillin) and a placebo cream¹, an oral placebo and an antibiotic cream (fusidic acid), or an oral placebo and a placebo cream. Flucloxacillin is an antibiotic (liquid and given by mouth in this study) that is commonly used for skin and other infections. Possible side effects from flucloxacillin include nausea (feeling sick), vomiting (being sick), diarrhoea, and developing a rash. Erythromycin is an antibiotic (liquid and given by mouth in this study) that is commonly used for many infections, including skin infections. Possible side effects from erythromycin include nausea (feeling sick), vomiting (being sick), diarrhoea, and developing a rash. Fusidic acid (Fucidin) is an antibiotic cream (or ointment) that is commonly used for skin infections. Possible side effects from fusidic acid include increased itching or soreness of the skin. ¹A placebo is a substance that appears to be identical to the medication but that has no medical effects in the body. CREAM Patient Information Sheet v2.0 12/10/2012 Page 1 of 4
  2. 2.  In addition, you will be asked to treat your child’s eczema with an emollient (moisturiser) and steroid cream (standard eczema treatment), and the research nurse will talk to you about other things that you can do to help care for your child’s eczema. The research nurse will also: o Ask you some questions about your child’s eczema and examine your child’s skin, in order to complete a questionnaire (this should take between 15-45 minutes). o Take clinical photographs of the part of your child’s eczema that may be infected. o Take swabs from their mouth, nose and skin. o Provide you with a diary to complete over the next 4 weeks.The photographs will be used to assess the severity and features of your child’s eczema, will include onlythe area with the infected eczema, and will be kept confidential. We will ensure that your child cannot beidentified from the photographs. We will not use the photographs for other purposes (teaching or researchpresentations) unless you give us specific permission to do so.The swabs will be used to look for the type of bacteria present in these locations (it is normal to havebacteria in all of these locations) and to see if they are resistant to any antibiotics. The whole processshould not take longer than two hours to complete.You will be asked to complete the diary every day (over the next 4 weeks) to record your child’s symptomsand all the medication used by your child for this flare of eczema. This should take less than 10 minutes tocomplete each day.The research nurse will return to your home to assess your child at the end of the first, second, and fourthweeks:At the second visit (Week 1):The research nurse will check how your child is doing, collect any unused study medication, and ask you tocomplete a brief questionnaire (less than 5 minutes).At the third visit (Week 2):The research nurse will check how your child is doing, ask you to complete a questionnaire, and collect thefirst 2 weeks of the symptom diary from you. The research nurse will also collect swabs from your child’sCREAM Patient Information Sheet v2.0 12/10/2012 Page 2 of 4
  3. 3. infected eczema, nose and mouth and show you how to take the swabs so that you can take them at 3 months and 12 months. The whole process should take less than 30 minutes. At the fourth visit (Week 4): The research nurse will check how your child is doing, ask you to complete a questionnaire, and collect the final two weeks of the symptom diary from you (this should take less than 30 minutes). At 3 months after your child joined the study: We will send you a brief questionnaire, and ask you to take some more swabs (the research nurse will have shown you how to do this) and return them to the laboratory by post using the container provided with the swabs (this should take less than 20 minutes). At 12 months after your child joined the study: Finally, twelve months after your child joined the study we will look at their general practice medical record to see if they have had further infections or any complications during this time. We will also ask you to take a final set of swabs and return them to the laboratory by post using the container provided (this should take less than 15 minutes).Ethical ApprovalThe study has been approved by an NHS Research Ethics Committee. The committee makes sure that thestudy is conducted ethically and in accordance with the requirements of the Clinical Trials Regulations.Study RecordsAll the information, including any personal information, will be kept completely confidential. Your GPwill know that you have agreed to participate in the study, and will provide us with follow-upinformation. However, your GP will not see your answers to the questionnaires or your diary. Neitheryour name nor your child’s name will given out or appear on any publications. Swab samples andphotographs will be anonymised, analysed and stored securely. The swabs will not be processed forDNA. The swab samples will be sent to a Cardiff University nominated laboratory for processing and storage.We will store the information collected during this research study including your child’s details, for 15 years.This information will be stored securely and confidentially by the research team at Cardiff University.Does my child have to take part?Your child does not have to take part in this study. Participation in the study is entirely voluntary and you andyour child are free to refuse to take part or withdraw from the study at any time without having to give a reason.If you do decide not to take part or to withdraw from the study, this will not affect the care that your childreceives.What are the possible disadvantages and risks of taking part?Taking part in the study will mean that we ask you to give up some of your time. There is a chance that yourchild might develop side effects from the study medication. However, the antibiotics used in this study are thesame types of antibiotics GPs prescribe every day to treat infected eczema, and the risk of side effects will beno greater than normal. Side effects are uncommon with these medications, and are not usually serious. Moredetails of the study medication will be provided at the time the research nurse shows you how to give your childtheir medication. If your child experiences any problems with the medication you should contact your GP andthe Trial Manager (details at the end of this leaflet). Whether or not your child enters this study there is a chancethat their eczema may get better or worse.What are the possible advantages about taking part?By participating in this study you will receive additional advice and support from the research nurse about caringfor eczema and using standard eczema treatments (emollients and steroid creams). The research nurse willalso monitor your child over the next four weeks. In addition, you will be helping us answer questions about thetreatment of eczema in children that should result in better care for children with eczema in the future. As atoken of appreciation for your time spent participating in the study, we will give you a total of £20 in gift vouchersduring the study (£10 at the start of the study, £5 at 3 months and £5 at 12 months).Will my taking part be kept confidential?All information collected about you and your child during the course of the study will be kept strictly confidential. CREAM Patient Information Sheet v2.0 12/10/2012 Page 3 of 4
  4. 4. What if I, or my child, do not want to carry on being part of the study?You can decide for your child to stop taking part in the study at any time and without needing to give a reason. Ifyou wish, you can contact the study manager or let the research nurse know next time they contact you. Inorder for us to understand the reasons why parents withdraw their children from the study, we may ask you whyyou have decided to withdraw. However, you do not have to give any reasons.If you decide to stop taking part, your child’s medical care and the legal rights of either you or your child will notbe affected in any way.What will happen to the results of the research study?At the end of the study, the results will be published in medical journals and presented at medical conferences.The results will also be provided to the UK National Eczema Society and NICE. This will allow us to tell otherdoctors and healthcare professionals about the results of the study.Information that identifies you or your child will not be presented. We will provide you with information of whereto access the published study. We will also update you with newsletters during, and at the end of, the study.Who has funded and approved the study?This study has been funded by the Department of Health’s Health Technology Assessment Programme and isbeing managed by Cardiff, Bristol and Dundee Universities.It has been approved by an independent NHS Research Ethics Committee. Their job is to protect your safety,rights, wellbeing and dignity.What if there is a problem?If at any point you are unhappy with any aspect of the study, please advise the South East Wales Trials Unit(SEWTU) research team (contact numbers below), or your general practitioner. If you remain unhappy andwish to formally complain, you can do this through the normal NHS complaints procedure.What do I need to do now?If you agree to consider having your child take part in the study please tell your doctor or nurse whether or notyou are happy for your child to take part. If your child is old enough you will probably want to discuss the studywith them. The research nurse can help you discuss the study with your child.Thank you for reading this information sheet and considering participation of your child in this study. Our team isexperienced, enthusiastic, dedicated and excited by the possibility of doing this important study to the highestinternational standards, and helping to improve the future care of children with eczema.Should you have any further questions or require further information about your child taking part youcan contact (during normal working hours): CREAM Study Manager, South East Wales Trials Unit (SEWTU), th 7 Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS Tel: +44 (0)29 20687665 E-mail: CREAM@cf.ac.uk Please note that this number is only for queries regarding the study; if you have an urgent medical problem please contact your doctor in the normal way. Alternatively you can visit our study website on: http://www.cream-study.co.uk CREAM Patient Information Sheet v2.0 12/10/2012 Page 4 of 4