Vabomere for Bacterial Infection

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Nebraska Medical Center, Omaha, NEBacterial InfectionVabomere - Drug
Eligibility
< 18
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug, Vabomere, to see if it is safe and effective in children with serious bacterial infections.

Eligible Conditions
  • Bacterial Infection

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

11 Primary · 0 Secondary · Reporting Duration: From assent / consent until day 7 safety follow up call

Day 7
Safety and tolerability: AEs/SAEs
Safety and tolerability: ECGs
Safety and tolerability: clinical safety laboratory results
Safety and tolerability: vital signs
Hour 6
Pharmacokinetics: AUC0-∞
Pharmacokinetics: Cmax
Pharmacokinetics: Cmin
Pharmacokinetics: Vss
Pharmacokinetics: drug clearance (CL)
Pharmacokinetics: t1/2
Pharmacokinetics: time to maximum plasma concentration (Tmax)

Trial Safety

Safety Progress

1 of 3

Side Effects for

Vabomere
12%Diarrhea
10%Hypokalemia
10%Anemia
8%Hypotension
8%Vomiting
8%Hypoglycemia
6%Hypomagnesemia
6%Systemic Candida
6%Tremor
4%Cardiac Arrest
4%General Physical Health Deterioration
4%Hypertension
4%Sepsis
4%Constipation
4%Melaena
4%Abdominal Distension
4%Leukopenia
4%Thrombocytopenia
4%Abdominal Pain
4%Rectal Hemorrhage
4%Nausea
4%Hypothermia
4%Urine Output Decreased
4%Oral Candidiasis
4%Back Pain
4%Headache
4%Dyspnea
4%Hyperbilirubinaemia
4%Myalgia
2%Gastrointestinal Hemorrhage
2%Multi-organ Failure
2%Renal Impairment
2%Extrasystoles
2%Blood Alkaline Phosphatase Increased
2%Generalized Edema
2%Septic Shock
2%Klebsiella Bacteremia
2%Superinfection Bacterial
2%Pneumonia Aspiration
2%Gangrene
2%Enterococcal bacteremia
2%Urosepsis
2%Pulmonary Embolism
2%Glioblastoma
2%Pulmonary Edema
2%Abdominal Pain Upper
2%Pain
2%Arterial Hemorrhage
2%Shock Hemorrhagic
2%Infusion Site Phlebitis
2%Leukocytosis
2%Stomatitis
2%Candiduria
2%Clostridium Difficile Colitis
2%Atrial Fibrillation
2%Hematuria
2%Renal Failure Acute
2%Tachycardia
2%Pruritus
2%Wound
This histogram enumerates side effects from a completed 2017 Phase 3 trial (NCT02168946) in the Vabomere ARM group. Side effects include: Diarrhea with 12%, Hypokalemia with 10%, Anemia with 10%, Hypotension with 8%, Vomiting with 8%.

Trial Design

1 Treatment Group

Single dose IV meropenem-vaborbactam
1 of 1

Experimental Treatment

67 Total Participants · 1 Treatment Group

Primary Treatment: Vabomere · No Placebo Group · Phase 1

Single dose IV meropenem-vaborbactam
Drug
Experimental Group · 1 Intervention: Vabomere · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Meropenem
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from assent / consent until day 7 safety follow up call

Who is running the clinical trial?

Rempex (a wholly owned subsidiary of Melinta Therapeutics, Inc.)Lead Sponsor
6 Previous Clinical Trials
528 Total Patients Enrolled
Department of Health and Human ServicesFED
204 Previous Clinical Trials
469,255 Total Patients Enrolled
Study DirectorStudy DirectorMelinta Therapeutics, Inc.
1,087 Previous Clinical Trials
483,507 Total Patients Enrolled

Eligibility Criteria

Age < 18 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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)." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.