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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
Must not have
Evidence of significant hepatic disease or dysfunction, including known acute viral hepatitis or hepatic encephalopathy
Use of meropenem within 48 hours of administration of study drug or 12 hours after study drug administration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from assent / consent until day 7 safety follow up call
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
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.
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.
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.
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.
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I am under 18 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have severe liver disease or symptoms like confusion due to liver problems.
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I haven't taken meropenem 48 hours before or 12 hours after the study drug.
Select...
I am not pregnant, breastfeeding, and my pregnancy tests are negative.
Select...
I am a male willing to use birth control or practice abstinence during the study.
Select...
My kidney function, measured by creatinine clearance, is below normal.
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I have not taken valproic acid in the last 30 days.
Select...
My BMI is not in the extreme high or low range for my age and height.
Select...
I have severe infection signs, like shock, not improving with fluids.
Select...
I am willing to use two forms of birth control or practice abstinence during the study.
Select...
I have previously been treated with vaborbactam or Vabomere.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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%
Hypotension
12%
Renal Failure Acute
8%
Nausea
8%
Abdominal Pain Upper
8%
Anemia
8%
Thrombocytopenia
8%
Hypokalemia
8%
Asthenia
8%
Transaminases Increased
8%
Renal Impairment
8%
Confusional State
8%
Restlessness
8%
Edema Peripheral
4%
Atrial Fibrillation
4%
Extrasystoles
4%
Cardiac Failure Congestive
4%
Clostridium difficile colitis
4%
Peritonitis
4%
Constipation
4%
Stomatitis
4%
Ascites
4%
Paraesthesia Oral
4%
Salivary Hypersecretion
4%
Leukopenia
4%
Leukocytosis
4%
Sickle Cell Anemia with Crisis
4%
Perinephric Abscess
4%
Hypomagnesemia
4%
Penile Hemorrhage
4%
Embolism
4%
Extremity Necrosis
4%
Generalized Edema
4%
Infusion Site Phlebitis
4%
Alanine Aminotransferase Increased
4%
Blood Bilirubin Increased
4%
Blood Fibrinogen Decreased
4%
Blood Urea Increased
4%
Electrocardiogram QT Prolonged
4%
Tremor
4%
Dizziness
4%
Parasthesia
4%
Somnolence
4%
Hematuria
4%
Renal Failure
4%
Tachycardia
4%
Delirium
4%
Disorientation
4%
Hallucination
4%
Dyspnea
4%
Pleural Effusion
4%
Pneumothorax
4%
Pruritus
4%
Rash Macular
4%
Skin Exfoliation
4%
Wound
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
Awards & Highlights
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.
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
232 Previous Clinical Trials
935,860 Total Patients Enrolled
Study DirectorStudy DirectorMelinta Therapeutics, Inc.
1,289 Previous Clinical Trials
502,306 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.