Studies

Antibiotic Prophylaxis versus Placebo in Infants Diagnosed with Hydronephrosis Antenatally: A Prospective, Randomized Controlled Trial

Principal Investigator: Dr. Luis Braga

Funded By: HHS New Investigator Fund (NIF), McMaster Surgical Associates, and The Physicians’ Services Incorporated (PSI) Foundation

Current Enrollment Number: 146

Study Status: ​Completed

STUDY SUMMARY

The overall objective of this randomized controlled trial is to determine the effect of continuous antibiotic prophylaxis (CAP) compared to placebo in reducing the number of febrile urinary tract infections in infants with prenatally detected hydronephrosis over the first year of life. The trial is currently being conducted in the 2G Pediatric clinic at McMaster Children's Hospital. This is a multicentre RCT in collaboration with The Hospital for Sick Children (Toronto) and Children's Hospital of Eastern Ontario (Ottawa).

NEWS

Data Safety Monitoring Board (DSMB)

The sixth DSMB meeting took place on June 18, 2015. At the meeting a total of 51 adverse events were reviewed. After a thorough evaluation, it was concluded that there were no concerns for the safety of the patients enrolled in the ALPHA study since none of the events were related to the study drug. A copy of the meeting report is attached below.

[DSMB Meeting #6 Report]

Participating Centers

1 . SickKids Hospital (Toronto)

The Hospital for Sick Children has became our first participating centre in 2013 to officially enroll a patient into the ALPHA Trial. Thus far, 10 patients have been enrolled from SickKids.

2. Childrens's Hospital of Eastern Ontario (Ottawa)

CHEO has recently joined as our 3rd recruiting site for the ALPHA trial. This site will begin recruitment in September 2015.

This marks an important leap forward for ALPHA and the collaboration between SickKids, McMaster and CHEO.

CONTACT US

For more information on the ALPHA study or if would like to join the study as a recruiting center please contact the ALPHA Research Coordinator:

Melissa McGrath, BASc. (Hons)
phone: 905-521-2100 x. 73654
email: mcgram2@mcmaster.ca

Participating Centre Resources

• Clinical Trial Registry Number: NCT01140516
• Health Canada No Objection Letter
• Protocol Version 2.5 (password protected)
• Ethics Approval: REB 09-255
• Case Report Forms V2.4
• CRF Completion Guide V7.0
• ALPHA REDCap SOP1.1: Data Completion, Queries, and Data Locking
• Study Newsletter (Volume 5)
• Next Steering Committee Meeting: October 2015
• To randomize a patient, please click below:Randomization Request
• To enter a patient into the REDCap database for the ALPHA study, please click the link below

PUBLICATIONS 

Peer Reviewed Journal Publications

• Tu HYV, Pemberton J, Lorenzo AJ, Braga LH. Economic Analysis of Continuous Antibiotic Prophylaxis of Prevention of Urinary Tract Infections in Infants with High Grade Hydronephrosis. J Pediatr Urol. 2015 Oct;11(5):246.e1-8.[Link to full text article on PubMed]
• Braga LH, Pemberton J, Heaman J, Demaria J, Lorenzo AJ. Pilot randomized, placebo controlled trial to investigate the effect of antibiotic prophylaxis on the rate of urinary tract infection in infants with prenatal hydronephrosis. J Urol. 2014 May;191(5 Suppl):1501-7. [Link to full text article on PubMed]
• Braga LH, Ruzhynsky V, Pemberton J, Farrokhyar F, DeMaria J, Lorenzo A. Evaluating practice patterns in the postnatal management of antenatal hydronephrosis: A national survey of pediatric urologists and nephrologists. Urology. 2014; 83 (4): 909-14. [Link to full text article on PubMed]
• Braga LH, Mijovic H, Farrokhyar F, Pemberton J, Demaria J, Lorenzo AJ. Antibiotic Prophylaxis for Urinary Tract Infections in Antenatal Hydronephrosis. Pediatrics. 2013; 131(1):e251-e261. [Link to full text article on PubMed]

Peer-Reviewed Abstracts

• Braga LH, Pemberton J, Heaman J, DeMaria J, Lorenzo A. Feasibility of Conducting a Prospective Blinded Randomized Placebo Controlled Trial to Investigate the Effect of Antibiotic Prophylaxis (AP) on the Rate of Urinary Tract Infection (UTI) in Infants with Antenatal Hydronephrosis (AHN): The ALPHA Pilot Study. Can Urol Assoc J. 2013 May-June; 7(5-6Suppl2): S91. http://www.spuonline.org/abstracts/2013/17.cgi.
• Braga LH, Heaman J, Pemberton J, DeMaria J on behalf of the ALPHA Steering Committee. Society of Fetal Urology (SFU) Grading System Compared To Anteroposterior Diameter (APD) Measurement For Monitoring Infants With High Grade Hydronephrosis: Preliminary Analysis From The Alpha Pilot Trial. Can Urol Assoc J. 2013 May-June; 7(5-6Suppl2): S91. http://www.multiwebcast.com/cua/2013/68th/31360/
• Mijovic H, Lorenzo A, Pemberton J, DeMaria J, Soojin K, Braga LH. Does Antibiotic Prophylaxis Prevent Urinary Tract Infections in Infants With Antenatally Detected Hydronephrosis? A Systematic Review. CUAJ. 2012; 6(3suppl1): S7. http://pediatrics.aappublications.org/content/131/1/e251.full.pdf
• Braga LH, Pemberton J, DeMaria J, Lorenzo AJ, Dave S, Cappolichio JP, Lau K. Evaluating Practice Patterns in the Treatment of Antenatal Hydronephrosis: A National Survey of Pediatric Urologists and Nephrologists. CUAJ. 2011;5(3Suppl1):59. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3125591/

Conference Abstracts

• Pemberton J, Lorenzo A, Braga LH. Cost Analysis Of Prophylactic Antibiotics Vs. Placebo To Prevent Urinary Tract Infections In Infants With High Grade Hydronephrosis. SPU Pediatric Urology Fall Congress. Las Vegas, Nevada. 
  2013-9-20. Published online September 2013
  http://fallcongress.spuonline.org/abstracts/2013/23.cgi
• Braga LH, Pemberton J, Heaman J, DeMaria J, Lorenzo A. Feasibility of Conducting a Prospective Blinded Randomized Placebo Controlled Trial to Investigate the Effect of Antibiotic Prophylaxis (AP) on the Rate of Urinary Tract Infection (UTI) in Infants with Antenatal Hydronephrosis (AHN): The ALPHA Pilot Study. American Urological Association (AUA) 2013 Annual Meeting. San Diego, USA. 2013-05-04.  Published online May 2013. http://spuonline.org/abstracts/2013/17.cgi
• Mijovic H, Lorenzo A, Pemberton J, Soojin K, Demaria J, Braga LH. Role Of Antibiotic Prophylaxis In Preventing Urinary Tract Infections In Infants With Antenatally Detected Hydronephrosis? A Systematic Review And Meta-Analysis. European Society of Urology (ESPU) Annual Meeting. Zurich, Switzerland. 2012-05-09. http://www.espu.org/events/previous-events/abstracts.

Presentations

• Pemberton J, Lorenzo A, Braga LH. Cost Analysis Of Prophylactic Antibiotics Vs. Placebo To Prevent Urinary Tract Infections In Infants With High Grade Hydronephrosis. SPU Pediatric Urology Fall Congress. Las Vegas, Nevada. 
  2013-9-20.
• Braga LH, Pemberton J, Heaman J, DeMaria J, Lorenzo A. Feasibility of Conducting a Prospective Blinded Randomized Placebo Controlled Trial to Investigate the Effect of Antibiotic Prophylaxis (AP) on the Rate of Urinary Tract Infection (UTI) in Infants with Antenatal Hydronephrosis (AHN): The ALPHA Pilot Study. American Urological Association (AUA) 2013 Annual Meeting. San Diego, USA. 2013-05-04.
• Mijovic H, Lorenzo A, Pemberton J, DeMaria J, Soojin K, Braga LH. Does Antibiotic Prophylaxis Prevent Urinary Tract Infections in Infants With Antenatally Detected Hydronephrosis? A Systematic Review. Canadian Urological Association (CUA) Annual Meeting. Banff, Canada. 2012-06-24.
• Mijovic H, Lorenzo A, Pemberton J, Soojin K, Demaria J, Braga L. Role of Antibiotic Prophylaxis In Preventing Urinary Tract Infections in Infants With Antenatally Detected Hydronephrosis? A Systematic Review and Meta-Analysis. European Society of Urology (ESPU) Annual Meeting. Zurich, Switzerland. 2012-05-09. 

Poster Presentations

• Braga LH, Pemberton J, Heaman J, DeMaria J, Lorenzo A. Feasibility of Conducting a Prospective Blinded Randomized Placebo Controlled Trial to Investigate the Effect of Antibiotic Prophylaxis (AP) on the Rate of Urinary Tract Infection (UTI) in Infants with Antenatal Hydronephrosis (AHN): The ALPHA Pilot Study. Canadian Urological Association (CUA) 2013 Annual Meeting. Niagara Falls, Ontario. 2013-06-25.
• Braga LH, Heaman J, Pemberton J, DeMaria J on behalf of the ALPHA Steering Committee. Society Of Fetal Urology (SFU) Grading System Compared To Anteroposterior Diameter (APD) Measurement For Monitoring Infants With High Grade Hydronephrosis: Preliminary Analysis From The Alpha Pilot Trial. Canadian Urological Association (CUA) 2013 Annual Meeting. Niagara Falls, Ontario. 2013-06-25.