The usefulness of cranberry syrup versus antibiotic prophylaxis with trimethoprim in infantile recurrent urinary tract infection
| ISRCTN | ISRCTN16968287 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16968287 |
| Secondary identifying numbers | PI070274 |
- Submission date
- 24/02/2011
- Registration date
- 10/03/2011
- Last edited
- 10/03/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Jose Uberos
Scientific
Scientific
Servicio de Pediatría
Hospital Clínico San cecilio
Avda Dr. Oloriz 16
Granada
18012
Spain
Study information
| Study design | Randomised double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised, double-blind analysis of the usefulness of cranberry syrup versus antibiotic prophylaxis with trimethoprim in infantile recurrent urinary tract infection |
| Study acronym | CSRTUI |
| Study objectives | 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(s) | Ethical Committee Clinical San Cecilio Hospital-dalucía (Spain), 04/01/2008 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Recurrence of urinary tract infection |
| Secondary outcome measures | Secondary resistance to antibiotics |
| Overall study start date | 01/01/2009 |
| Completion date | 31/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 210 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2009 |
| Date of final enrolment | 31/12/2010 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Clínico San cecilio
Granada
18012
Spain
18012
Spain
Sponsor information
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)
Hospital/treatment centre
Hospital/treatment centre
Subdirección General Evaluación y Fomento de la Investigación.
Instituto de Salud Carlos III.
C/ Sinesio Delgado, 6
28029 Madrid
Madrid
28029
Spain
"ROR" |
https://ror.org/00ca2c886 |
|---|
Funders
Funder type
Hospital/treatment centre
Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)- Health Research Fund (Fondo de Investigaciones Sanitarias)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2015 | Yes | No |
Editorial Notes
10/03/2017: Publication reference added.
