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
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).
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]
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.
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