CIRCumcision and Urinary Tract Infections in Boys With Posterior Urethral Valves (CIRCUP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Centre Hospitalier Universitaire de la Réunion
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT01537601
First received: February 17, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

Children with posterior urethral valves (PUV) are at risk of presenting febrile urinary tract infections (UTI). Circumcision has been shown to decrease the number of febrile UTIs in healthy children. The effect of circumcision on the number of UTIs in boys with PUV has not yet been studied. Through a prospective randomised trial of children with posterior urethral valves the investigators wish to determine the effect of circumcision on the risk of presenting febrile UTIs. One group will be on antibiotic prophylaxis alone and the other will be on antibiotic prophylaxis plus circumcision performed at the time of valve resection. Both groups will be followed for two years, with clinical examination at 1, 3, 6, 12, 18 and 24 months. A DMSA scan will be performed at 1-2 and 24 months and biological renal function will also be monitored. The relative risk of presenting a febrile UTI in each group will be determined. Clinical, radiological and antenatal data concerning each child will be analysed.


Condition Intervention
Posterior Urethral Valves
Procedure: Circumcision
Other: Antibiotic prophylaxis alone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Circumcision on the Risk of Febrile Urinary Tract Infections in Children With Posterior Urethral Valves.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de la Réunion:

Primary Outcome Measures:
  • Relative risk of presenting a febrile UTI [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of children with febrile UTIs in each group at two years [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evolution of compliance to antibioprophylaxis. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Evolution of the grade of reflux [ Time Frame: At diagnosis and at 3 months ] [ Designated as safety issue: No ]
  • Comparison of the number of children who will show deterioration of their DMSA scan between children who have had UTIs and those who have not. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • number and type of adverse effects related to circumcision and antibiotic prophylaxis [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Identification of the responsible bacteria [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: August 2012
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Antibiotic prophylaxis alone
Children will be on antibioprophylaxis and will not have a circumcision.
Other: Antibiotic prophylaxis alone
Antibiotic prophylaxis alone
Experimental: Circumcision and antibiotic prophylaxis
Children will have a circumcision at the time of valve resection and will be on antibioprophylaxis
Procedure: Circumcision
Circumcision

Detailed Description:

After diagnosis of posterior urethral valves, children will be randomised either to antibioprophylaxis alone or antibioprophylaxis plus circumcision. Circumcision will be performed at the time of valve resection. Children will undergo a cystogram at three months to control valve resection. They will be followed for two years and the number of febrile UTIs in each group will be compared. The diagnosis of febrile UTI will be confirmed by urethral catheterisation or suprapubic aspiration. A DMSA scan will be performed at the beginning and end of the study to determine whether children who have presented febrile UTIs show deterioration of their DMSA as compared to those who did not present febrile UTIs.

  Eligibility

Ages Eligible for Study:   up to 28 Days
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male
  • aged 0 to 28 days
  • diagnosed with posterior urethral valves within the 28 first day of life
  • holders of parental authority affiliated to French national health insurance
  • informed consent signed by holders of parental authority

Exclusion Criteria:

  • boys with hypospadias or epispadias or any other anomaly rendering circumcision impossible
  • concomitant participation to another clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01537601

Contacts
Contact: Luke harper, MD +262 (0) 262 90 64 94 luke.harper@chu-reunion.fr
Contact: Vanessa Basque +262 (0) 262 35 95 25 vanessa.basque@chu-reunion.fr

Locations
France
Department of pediatric surgery, Regional Hospital Reunion Island - Felix Guyon Site Recruiting
Saint Denis de La Réunion, France, 97405
Contact: Luke Harper, MD    +262 (0) 262 90 64 94    luke.harper@chu-reunion.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de la Réunion
Investigators
Principal Investigator: Luke Harper, MD Regional Hospital Reunion Island - Felix Guyon Site
Principal Investigator: Eric Dobremez, MD CHU Bordeaux, Hôpital Pellegrin Enfants
Principal Investigator: Laurent Fourcade, MD CHU Limoges - Hôpital de la mère et de l'enfant
Principal Investigator: Nicolas Kalfa, MD CHU Montpellier - Hôpital Lapeyronie
Principal Investigator: Frédéric Aubert, MD CHU St Jacques - Besançon
Principal Investigator: Benjamin Frémond CHU Rennes
Principal Investigator: Al El Ghoneimi, MD CHU Robert Debré
Principal Investigator: Stephen Lortat-Jacob, MD CHU de Necker Enfants Malades
Principal Investigator: Jean Michel Guys, MD Hôpital d'enfants de la Timone, Marseille
Principal Investigator: Thierry Merrot, MD CHU Nord, Marseille
Principal Investigator: Marc David Leclair, MD CHU Nantes
Principal Investigator: Georges Audry, MD CHU Armand Trousseau, Paris
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier: NCT01537601     History of Changes
Other Study ID Numbers: 2012/CHR/01
Study First Received: February 17, 2012
Last Updated: June 11, 2014
Health Authority: France: Ministry of Health

Keywords provided by Centre Hospitalier Universitaire de la Réunion:
Posterior urethral valves
Febrile urinary tract infection
Circumcision
Antibioprophylaxis

Additional relevant MeSH terms:
Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 20, 2014