Your session is about to expire
← Back to Search
Beta-lactamase inhibitor
Vabomere for Pediatric Bacterial Infections (TANGOKIDS Trial)
Phase 1
Recruiting
Research Sponsored by Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Sufficient intravascular access (peripheral or central) to receive study drug
Male or female from birth to < 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from assent / consent until day 7 safety follow up call
Awards & highlights
TANGOKIDS Trial Summary
This trial is testing a new drug, Vabomere, to see if it is safe and effective in children with serious bacterial infections.
Who is the study for?
This trial is for hospitalized children from birth to under 18 years with serious bacterial infections or needing peri-operative antibiotics. They must have stable vital signs, appropriate intravascular access, and not be at high risk of complications as judged by the investigator. Females in puberty must use birth control or abstain sexually; males also need to practice safe sex.Check my eligibility
What is being tested?
The study tests a single infusion dose of Vabomere (meropenem-vaborbactam) in young patients. It aims to find the right dosage, understand how the drug works in their bodies (pharmacokinetics), and assess its safety and tolerability.See study design
What are the potential side effects?
Potential side effects may include allergic reactions similar to other beta-lactam antibiotics, digestive issues like diarrhea or nausea, skin rashes, changes in blood test results indicating liver or kidney function alterations.
TANGOKIDS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a working IV line for receiving the study drug.
Select...
I am under 18 years old.
TANGOKIDS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from assent / consent until day 7 safety follow up call
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from assent / consent until day 7 safety follow up call
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pharmacokinetics: AUC0-∞
Pharmacokinetics: Cmax
Pharmacokinetics: Cmin
+8 moreSide effects data
From 2017 Phase 3 trial • 77 Patients • NCT0216894616%
Sepsis
16%
Septic Shock
16%
Diarrhea
12%
Renal Failure Acute
12%
Hypotension
8%
Nausea
8%
Abdominal Pain Upper
8%
Asthenia
8%
Hypokalemia
8%
Anemia
8%
Transaminases Increased
8%
Confusional State
8%
Restlessness
8%
Renal Impairment
8%
Thrombocytopenia
8%
Edema Peripheral
4%
Ascites
4%
Leukocytosis
4%
Parasthesia
4%
Skin Exfoliation
4%
Embolism
4%
Somnolence
4%
Hallucination
4%
Dyspnea
4%
Pleural Effusion
4%
Wound
4%
Rash Macular
4%
Perinephric Abscess
4%
Penile Hemorrhage
4%
Cardiac Failure Congestive
4%
Sickle Cell Anemia with Crisis
4%
Pneumothorax
4%
Alanine Aminotransferase Increased
4%
Delirium
4%
Salivary Hypersecretion
4%
Leukopenia
4%
Disorientation
4%
Hypomagnesemia
4%
Extremity Necrosis
4%
Renal Failure
4%
Electrocardiogram QT Prolonged
4%
Tremor
4%
Atrial Fibrillation
4%
Extrasystoles
4%
Generalized Edema
4%
Infusion Site Phlebitis
4%
Constipation
4%
Hematuria
4%
Clostridium difficile colitis
4%
Stomatitis
4%
Blood Bilirubin Increased
4%
Dizziness
4%
Blood Urea Increased
4%
Peritonitis
4%
Blood Fibrinogen Decreased
4%
Pruritus
4%
Paraesthesia Oral
4%
Tachycardia
4%
Cerebral Hemorrhage
4%
Convulsion
4%
Oral Candidiasis
4%
Candiduria
4%
Clostridium Difficile Colitis
4%
Bacteremia
4%
Pseudomonal Bacteremia
4%
Urinary Tract Infection
4%
Urinary Tract Infection Enterococcal
4%
Hypocalcemia
4%
Malnutrition
4%
Metabolic Acidosis
4%
Type 2 Diabetes Mellitus
4%
Vitamin B Complex Deficiency
4%
Pain
4%
Malaise
4%
Blood Alkaline Phosphatase Increased
4%
Incision Site Pain
4%
Adrenal Insufficiency
4%
Lipoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Best Available Therapy
Vabomere
TANGOKIDS Trial Design
1Treatment groups
Experimental Treatment
Group I: Single dose IV meropenem-vaborbactamExperimental Treatment1 Intervention
Vabomere (meropenem-vaborbactam) for IV injection will be administered as a single dose diluted in normal saline infused IV over 3 hours
Cohort 1 (n=8): 12 to < 18 years of age (40 mg/kg)
Cohort 2 (n=8): 6 to < 12 years of age (40 mg/kg)
Cohort 2b (n=4): 6 to < 12 years of age (60 mg/kg)
Cohort 3 (n=8): 2 to < 6 years of age (60 mg/kg)
Cohort 4 (n=8): 3 months to < 2 years of age (60 mg/kg)
Cohort 5 (n=24): Birth to < 3 months of age (dose TBD)
Group A: Gestational Age (GA) < 32 weeks, Postnatal Age (PNA) < 2 weeks (n=6)
Group B: GA < 32 weeks, PNA > 2 weeks (n=6)
Group C: GA > 32 weeks, PNA < 2 weeks (n=6)
Group D: GA > 32 weeks, PNA > 2 weeks (n=6)
Cohort 6 (n=7): 2 to < 12 years of age and ≤ 35 kg of weight (80 mg/kg)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meropenem
FDA approved
Find a Location
Who is running the clinical trial?
Rempex (a wholly owned subsidiary of Melinta Therapeutics, LLC)Lead Sponsor
Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)Lead Sponsor
6 Previous Clinical Trials
536 Total Patients Enrolled
Department of Health and Human ServicesFED
226 Previous Clinical Trials
928,882 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe liver disease or symptoms like confusion due to liver problems.I haven't taken meropenem 48 hours before or 12 hours after the study drug.I have a working IV line for receiving the study drug.I am not pregnant, breastfeeding, and my pregnancy tests are negative.I don't have any health issues that could make the study risky for me or affect the study drug's action.I am a male willing to use birth control or practice abstinence during the study.My kidney function, measured by creatinine clearance, is below normal.I have not taken valproic acid in the last 30 days.My BMI is not in the extreme high or low range for my age and height.I am under 18 years old.I will stay in the hospital for at least 6 hours after getting the study drug.I am using birth control or am not sexually active.I am in the hospital receiving antibiotics for an infection or as a preventive measure before surgery.I have severe infection signs, like shock, not improving with fluids.I am willing to use two forms of birth control or practice abstinence during the study.I have previously been treated with vaborbactam or Vabomere.I have not taken probenecid in the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Single dose IV meropenem-vaborbactam
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation the first of its kind?
"Since 2016, there has been a significant body of research dedicated to Vabomere. Rempex (a subsidiary of Melinta Therapeutics) launched the initial trial in 2016 which included 60 participants and led to its Phase 1 drug approval. At present, 10 different investigations are actively taking place internationally across 30 cities within 15 nations."
Answered by AI
Could you provide an exact figure of the participants enrolled in this research?
"To meet the requirements of this clinical trial, 60 participants must be recruited that fit specified inclusion criteria. Patients may take part in this medical study at Ronald Reagan UCLA Medical Center (Los Angeles) and Ann & Robert H. Lurie Children's Hospital of Chicago (Chicago)."
Answered by AI
What diseases typically respond positively to Vabomere?
"Vabomere is mainly used to treat urinary tract infections, yet can be also utilised for treating communicable diseases, klebsiella pneumoniae, meningitis and select bacterial illnesses."
Answered by AI
What precautions should be taken when utilizing Vabomere?
"At Power, we gave Vabomere a rating of 1 on our safety scale given the limited data from Phase 1 trials that suggests its efficacy and security."
Answered by AI
Are there additional experiments utilizing Vabomere that have been conducted?
"Vabomere was first studied at University of Nebraska Medical Center in 2016 and there are currently 70 completed studies. 10 research projects are actively recruiting subjects, a majority of which located in Los Angeles."
Answered by AI
How widely dispersed is the current clinical test?
"This clinical trial is taking place in multiple locations, including the Ronald Reagan UCLA Medical Center located in Los Angeles, California; Ann & Robert H. Lurie Children's Hospital of Chicago situated in Chicago, Illinois; and Rady Children's Hospital San Diego found in San Diego, New jersey , among other healthcare facilities."
Answered by AI
Are there any vacancies available in this research endeavor?
"According to clinicaltrials.gov, these experiments are ongoing and open for enrollment. The study was initially uploaded on July 1st 2016 with the most recent edit occurring August 9th 2021."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger