|
Where we are What's new? |
 |
What is PRIVENT? Information for parents:Is this your child?Case 1: Case 2: What the research showsA review was published by the Children's Hospital at Westmead looking at all the available studies of the use of antibiotics in the prevention of recurrent urinary tract infections in children. It concluded that previous studies were poorly done and that there still remains uncertainty about whether antibiotics prevent recurrent urinary tract infections. A study is currently running called PRIVENT, which is aimed at conclusively answering this question. What is PRIVENT?A research project looking at the effectiveness of long-term antibiotics for the prevention of recurrent urinary tract infection in children The recruitment for PRIVENT has now ceased and the study results will be known in April 2008. Why is this study necessary?Rountine clinical practice for children with UTI is to treat them with antibiotics and investigate their renal tracts using ultrasound, MCU and DMSA. Children found to have vesicoureteric reflux(VUR) are placed on long-term antibiotics in the hope of preventing further infections. This practice is unproven and accumulating evidence suggests that long-term antibiotic treatment does not prevent recurrent infections in children with VUR. Up to 30% of these patients have break-through infections. Children with normal renal tracts are not usually given prophylactic antibiotics but approximately 15% will develop a further infection. This study is designed to answer two questions: 1. Are prophylactic antibiotics in patients with VUR effective in the prevention of further infections? 2. Is there a group of UTI patients with normal renal tracts who are at a risk of recurrent infections and who might benefit from antibiotic prophylaxis? Who can be involved?Children who have had one or more urine infections who might benefit from long-term antibiotics. Children with spina bifida and spinal injuries who need regular catheterisation and children with renal tract obstruction can not be part of this project. What is involved?After your child has received the standard clinical treatment and tests for their UTI, your doctor will give you information about the study. When you have had time to think about it, you will be asked if you would like to participate. If you would like to be involved, you will be asked to sign a consent form. A copy of this will be made for you. If you do not wish your child to be involved, it will not affect your treatment in anyway. Participants will be given a 2-week prescription for medication. There is no cost involved; we provide the medication for free. Two weeks later we will telephone you to see how you are going. If you and your child are happy to continue, we will phone the trial centre, who will randomly allocate you to either antibiotics or a similar inactive medication. To save you a trip to the hospital we will have your prescription filled and send it to you by courier. We will also post some patient diaries for you to fill in each time your child visits their doctor. A letter will be sent to your doctor and paediatrician, informing them of the test results and your involvement in the study. Another appointment will be made for you at our clinic in 3 months time. At each check-up visit you will be given your next supply of medicine. How many visits?A check-up every three months, so one at the start, then 3, 6, 9 and 12 months later. After 12 monthsAt the end of the study some children will require a second DMSA test, which will be organised for you. Your child may need to continue seeing a paediatrician for checkups after the trial. Some children will not need continuing visits. You can call us during or any time after the study if you have questions. Will I know what medicine my child is taking?During the 12 months, you will not know which medicine your child takes. At the end of 12 months you will receive a letter from Sandra Puckeridge telling you what medication your child had been taking. Trial ProcessTo view the trial process click on the following link CHART Frequently Asked QuestionsWhat if my child is sick between appointments?You can take your child to your local doctor, medical clinic or you can bring them in to the Emergency Department here at the Children’s Hospital at Westmead. If your child has a UTI during the study, they will be taken off the trial medication and be given appropriate antibiotics for the infection. If your child develops another infection (ie. not a UTI), your GP can prescribe your child another antibiotic if appropriate. Your child must still continue on the trial medication. Can I stop the trial before the one year is up?The study is voluntary meaning that children can be withdrawn from the study at any stage. Although we do prefer that once you have consented, your participation is expected for the duration of the trial. Is it possible to find out what trial medication my child was given before the one year is up?If there are no further UTI's by the end of the study, you will receive a letter telling you what was in the trial medication. If your child develops a UTI during the study period, you will also be sent a letter telling you what was in the trial medication. It is also possible to find out what was given in rare circumstances of medical interest. What results do you have so far?As a rule we do not peek at the results before the study is complete so we can not give you any information on this. What happens at the end of the study?Once the year is complete, there is no need to give further trial medication. You will find out what trial medication was given by post and you will be referred back to your GP or paediatrician for ongoing care. Will the care of my child differ in any way if on the trial?No. We assure you that your child receives the same quality of care as any other child seen in this hospital. More QuestionsPhone: Alison Lowe +61 2 9845 1468 or Dr Yashwant Sinha +61 2 9845 1483 |