Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI070274
Study information
Scientific title
Randomised, double-blind analysis of the usefulness of cranberry syrup versus antibiotic prophylaxis with trimethoprim in infantile recurrent urinary tract infection
Acronym
CSRTUI
Study hypothesis
Given the state of uncertainty about the usefulness of antibiotic prophylaxis in children with vesicoureteral reflux we propose the following hypothesis:
1. How effective is the cranberry syrup in preventing recurrent urinary tract infections in children?
2. What organisms are mainly responsible for recurrent urinary tract infections in patients receiving prophylaxis with cranberry syrup?
Ethics approval
Ethical Committee Clinical San Cecilio Hospital-dalucía (Spain), 04/01/2008
Study design
Randomised double-blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Recurrent urinary tract infection
Intervention
Experimental group receive an evening dose of 3 ml of cranberry syrup which ensures a fixed concentration of 36 mg of proanthocyanidins. The administration is done before dinner. If vomiting occurs within 30 minutes after administration, the dose is repeated in full.
Standard treatment group receive an standard treatment with trimethoprim at 0.2 ml/kg and masked with red cochineal. Management should be before dinner. If vomiting occur within 30 minutes after administration, the dose is repeated in full.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Recurrence of urinary tract infection
Secondary outcome measures
Secondary resistance to antibiotics
Overall trial start date
01/01/2009
Overall trial end date
31/12/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Children 0 to 5 years consulting for any of the points 2, 3 and 4 of this paragraph, on any visits to specialists of the Hospital Virgen de las Nieves, Clínico San Cecilio de Granada and Baza County Hospitals and Motril
2. More than a urinary tract infection confirmed by urine culture (> 100,000 colonies/ml) and sediment with more than 20 leukocytes per field, in a urine sample collected on the prowl or urine collection bag after urethral meatus asepsis with chlorhexidine
3. Existence of any degree vesicoureteral reflux confirmed by cystography or dilatation of the renal pelvis or urinary tract confirmed by ultrasound
4. Existence of any anatomical abnormality of the urinary tract that current protocols of action to justify continued antibiotic prophylaxis
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
210
Participant exclusion criteria
1. Coexistence of other infectious diseases
2. Coexistence of metabolic diseases
3. Renal failure
4. Hepatic impairment
5. Existence of allergy or intolerance to any component of cranberry or trimethoprim
6. I want to show the legal responsibility not to participate in the study
Recruitment start date
01/01/2009
Recruitment end date
31/12/2010
Locations
Countries of recruitment
Spain
Trial participating centre
Hospital Clínico San cecilio
Granada
18012
Spain
Sponsor information
Funders
Funder type
Hospital/treatment centre
Funder name
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)- Health Research Fund (Fondo de Investigaciones Sanitarias)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/25300782