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Glycopeptide Antibiotic
Dalbavancin for Bacterial Skin Infections
Phase 3
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 48 - 72 hours
Awards & highlights
Study Summary
This trial will study the safety and effectiveness of dalbavancin in children with bacterial skin infections.
Who is the study for?
This trial is for children from birth to 17 years with serious skin infections, including those caused by MRSA. It's open to kids showing signs like fever or abnormal white blood cell counts and who need hospitalization. Babies under 3 months must meet additional criteria. Kids can't join if they have significant liver or kidney issues, recent investigational drug use, certain severe infections, immune problems, or are pregnant/nursing.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of dalbavancin in treating children's bacterial skin infections. Dalbavancin will be given either as a single dose or two doses to see which works better against Gram-positive bacteria like MRSA that cause these infections.See study design
What are the potential side effects?
Dalbavancin may cause side effects such as allergic reactions, digestive issues (like nausea and diarrhea), changes in liver enzymes (which might indicate liver irritation), infusion-related reactions (like rash or itching), and possibly blood disorders.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 48 - 72 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 48 - 72 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in number of patients with the presence of either Clostridium difficile (CD), vancomycin-resistant enterococci (VRE), or both CD and VRE in bowel flora
Number of patients with abnormal audiologic assessment
Secondary outcome measures
All-cause mortality: For patients age birth to < 3 months, all-cause mortality will be determined at test of cure (TOC) visit
Clinical response
Clinical response evaluated at follow-up visit: Cure
+11 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Dalbavancin, two dosesExperimental Treatment1 Intervention
Group II: Dalbavancin, single doseExperimental Treatment1 Intervention
Group III: ComparatorActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dalbavancin two dose
2017
Completed Phase 3
~200
Dalbavancin single dose
2017
Completed Phase 3
~200
Find a Location
Who is running the clinical trial?
AbbVieLead Sponsor
954 Previous Clinical Trials
500,906 Total Patients Enrolled
AllerganLead Sponsor
781 Previous Clinical Trials
276,370 Total Patients Enrolled
Rinal Patel, Pharm.D.Study DirectorAllergan, plc
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious liver problem.Children with serious kidney problems cannot participate, and babies under three months old with moderate or severe kidney problems also cannot participate.You have a skin infection with certain symptoms like fever, high or low white blood cell count, or infection involving deeper tissue that needs major surgery.You have severe infections that require long-term antibiotic treatment, specifically caused by certain types of bacteria or fungi, or infections related to medical devices.You have a severe skin infection, surgical wound infection, or a deep skin infection called cellulitis.You have had a severe drop in blood pressure, taken strong antibiotics, or had an infection caused by resistant germs within the last 96 hours.Babies under 3 months old with certain infections or blood poisoning, and who meet specific medical and lab test requirements.Children and teenagers up to 17 years old with a skin infection caused by certain types of bacteria.You have certain medical conditions, weak immune system, strong allergic reactions to specific antibiotics, very serious illness, or are pregnant or nursing.You have a simple skin infection and other health issues that might affect the study evaluation.You have a serious infection that requires hospitalization and intravenous antibiotics.You have a serious infection that affects deep tissue or needs major surgery to treat.You have a slow or fast heartbeat, or your heartbeat is not steady.You have a body temperature below 36°C or above 38.5°C.
Research Study Groups:
This trial has the following groups:- Group 1: Dalbavancin, single dose
- Group 2: Comparator
- Group 3: Dalbavancin, two doses
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
MRSA Patient Testimony for trial: Trial Name: NCT02814916 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this a new or different type of clinical trial?
"AbbVie's Dalbavancin single dose has completed Phase 3 drug approval and is currently being tested in 61 cities across 21 countries. The first study was completed in 2017 with 188 participants. As of now, 34 studies have been finished."
Answered by AI
How many different facilities are administering this trial?
"There are many locations recruiting patients for this study, including SUNY Upstate Medical University Hospital in Syracuse, SUNY Upstate Medical University /ID# 236831 in New Brunswick, Robert Wood Johnson University Hospital in Panama City, as well as 16 other sites."
Answered by AI
Might I be a candidate to join this clinical trial?
"Children aged 0 to 17 who suffer from bacterial infections are eligible for this 188-person clinical trial."
Answered by AI
Are there other examples of Dalbavancin's efficacy in treating patients?
"At the moment, there are 6 trials involving Dalbavancin single dose. Of these ongoing studies, 2 have progressed to Phase 3 testing. Although the majority of research is conducted in Aurora, Colorado; clinical trials for this treatment can be found at 157 different locations."
Answered by AI
Will this experiment involve any participants who are over the age of fifty?
"This particular trial is for patients that are 0-17 years old. Out of the 882 applicable studies, this one falls in the age bracket with the most trials available 219."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
California
What site did they apply to?
Cleveland Clinic
University of California, Los Angeles /ID# 237533
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
1
Why did patients apply to this trial?
No matter what use or how often I clean the affected area it will clear up for a bit, then come back unexpectedly.
PatientReceived 2+ prior treatments
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