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Antibiotic

Antibiotics for Fetal Hydronephrosis (ALPHA Trial)

N/A
Waitlist Available
Led By Luis H Braga, MD, MSc, PhD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Infants with AHN (one to seven months of age) confirmed postnatally with renal-bladder ultrasound and/or a dilated ureter ≥ 7mm
Patients without grades II to V VUR determined by voiding cystogram (includes UPJO-like and primary megaureter (hydroureteronephrosis) only)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the outcome measures will be assessed at 12 months
Awards & highlights

ALPHA Trial Summary

This trial looks at whether giving antibiotics to pregnant women who have a fetus with hydronephrosis can help prevent urinary tract infections in the child.

Who is the study for?
This trial is for infants aged 1-7 months with severe antenatal hydronephrosis, confirmed postnatally. They must not have previous kidney failure, be in another study, or have certain urinary tract conditions like high-grade VUR or Prune-Belly syndrome. Infants allergic to trimethoprim or needing chronic antibiotics for other issues can't join.Check my eligibility
What is being tested?
The study tests if antibiotic prophylaxis (using Trimethoprim) reduces urinary infections in infants with severe prenatal hydronephrosis compared to a placebo (Simple Syrup). It aims to guide treatment for the most common fetal abnormality detected by ultrasounds.See study design
What are the potential side effects?
Trimethoprim may cause side effects such as rash, itching, nausea, vomiting and an increased risk of sunburn. Serious but rare side effects include blood disorders and liver inflammation.

ALPHA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My infant has a confirmed kidney issue with a dilated ureter.
Select...
My bladder and kidneys do not have severe reflux.
Select...
My kidney swelling is severe.

ALPHA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the outcome measures will be assessed at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and the outcome measures will be assessed at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine whether antibiotics (ATB) prophylaxis prevents urinary tract infection (UTI) in infants with antenatal hydronephrosis (AHN).

ALPHA Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TrimethoprimActive Control1 Intervention
Prophylactic Antibiotics
Group II: Simple syrupPlacebo Group1 Intervention
2mg/kg,orally until febrile UTI occurs or until completion of the study if the patients do not develop any UTI.

Find a Location

Who is running the clinical trial?

McMaster Surgical AssociatesOTHER
16 Previous Clinical Trials
46,359 Total Patients Enrolled
Hamilton Health Sciences CorporationOTHER
365 Previous Clinical Trials
300,643 Total Patients Enrolled
McMaster UniversityLead Sponsor
876 Previous Clinical Trials
2,595,840 Total Patients Enrolled

Media Library

Trimethoprim (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT01140516 — N/A
Hydronephrosis Research Study Groups: Trimethoprim, Simple syrup
Hydronephrosis Clinical Trial 2023: Trimethoprim Highlights & Side Effects. Trial Name: NCT01140516 — N/A
Trimethoprim (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01140516 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this research endeavor?

"At present, this trial is not accepting new candidates. The study was posted on July 1st of 2010 and last updated on April 4th 2022. However, if you are interested in other trials, there are 92 that involve hydronephrosis and 16 studies focusing upon Trimethoprim presently enrolling patients."

Answered by AI

Is my profile suited to participate in this clinical experiment?

"This clinical trial welcomes 160 participants who have hydronephrosis and are between 1 month to 7 months of age."

Answered by AI

To what ailments is Trimethoprim commonly prescribed?

"Trimethoprim is traditionally used to combat shigella-induced enteritis, however it has been successfully employed in the treatment of otitis media, cholera, and other forms of shigellosis."

Answered by AI

Is there space for additional participants in this trial?

"Recruiting for this trial has ceased; it was initially posted on July 1st 2010 and most recently amended April 4th 2022. If you are searching for other trials, there currently exist 92 studies with hydronephrosis accepting patients, as well as 16 studies utilizing Trimethoprim in their research actively admitting individuals."

Answered by AI

What precedent has been established regarding Trimethoprim through medical experimentation?

"At the moment, a total of 16 Trimethoprim trials are currently ongoing with 3 in their final stage. Participants can be found at 39 distinct sites with Montreal, Quebec being the primary area for these clinical experiments."

Answered by AI

Is this trial open to individuals aged twenty-five and over?

"This trial is recruiting infants that are between 1 and 7 months of age."

Answered by AI
~5 spots leftby Sep 2024