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PRIVENT: Study Information for Health ProfessionalsWhat is PRIVENT? | Eligibility Criteria | FAQ | Trial Flowchart What is PRIVENT?PRIVENT (Prevention of Recurrent urinary Infection in children with VEsicoureteric reflux and Normal renal Tracts), a NHMRC funded randomised placebo-controlled trial of antibiotics to prevent recurrent urinary tract infection in children. The Trial Procedure?Approximately 750 children who have had at least one incident of confirmed, symptomatic urinary tract infection (UTI) will be enrolled. Routine imaging tests will be carried out (MCU, ultrasound and DMSA) where clinically appropriate. Approximately 30% of these children will have vesicoureteric reflux (VUR) and 40% will have kidney damage. Children will be randomised to receive either antibiotic or placebo. The investigators will remain blinded to their allocation. Children will be seen at three monthly intervals for 12 months. If a child develops further UTI's, the code will be broken and appropriate clinical treatment given. The outcomes of interest are further UTI's, adverse reactions to the antibiotics and other illness events. Why is this trial necessary?As you know, routine 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 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:
Significance of UTIUTI in childhood is common. About one in ten Australian children develop at least one UTI by the age of 15 (approximately 88,000 each year). UTI is an unpleasant, acute illness in children and also has the potential to seriously damage the kidneys. Benefits of the Trial
Definition of UTI
Eligibility Criteria
TreatmentCotrimoxazole (2mls/kg/day of trimethoprim) or placebo will be given as a single daily dose in the same volume. Height, weight, blood pressure and medication side effects will be recorded at each follow-up visit. Children who develop further UTI's will have their randomisation code broken and routine clinical care given. Trial ProcessTo view the flowchart of the trial process click here Flowchart Frequently Asked QuestionsWhat happens if the child becomes unwell?If the child has a UTI during the study, they will be taken off the trial medication and be given appropriate antibiotics for the infection. If the child develops another infection (ie. not a UTI), antibiotics can still be prescribed if appropriate. The child must still continue on the trial medication. Can the trial be stopped 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 parents have consented, their 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 the 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 look 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 expected to give ongoing care. More QuestionsAlison Lowe Dr Yashwant Sinha |