Condition category
Urological and Genital Diseases
Date applied
24/02/2011
Date assigned
10/03/2011
Last edited
10/03/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof JOSE UBEROS

ORCID ID

Contact details

Servicio de Pediatría
Hospital Clínico San cecilio
Avda Dr. Oloriz 16
Granada
18012
Spain

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 Committe Clinical San Cecilio Hospital-dalucía (Spain) approved on 4th January 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 below 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 measures

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

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

Servicio de Pediatría
Granada
18012
Spain

Sponsor information

Organisation

Carlos III Institute of Health (Instituto de Salud Carlos III) (Spain)

Sponsor details

Subdirección General Evaluación y Fomento de la Investigación.
Instituto de Salud Carlos III.
C/ Sinesio Delgado
6
28029 Madrid
Madrid
28029
Spain

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes