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Renal Biomarker
Optimized Beta-lactam Dosing for Bacterial Infections
Phase 4
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-2
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
"This trial aims to compare different methods of assessing kidney function in critically ill adult patients with certain infections. The study will use Cystatin C and Cystatin C-based estimated Glomerular Filtr
Who is the study for?
This trial is for critically ill adults with suspected or confirmed antibiotic-resistant Gram-negative bacterial infections. Participants must have kidney function that can be measured and agree to take the study drug, Iohexol.
What is being tested?
The study tests if Cystatin C (CysC) and equations based on it are better than traditional methods at predicting how drugs like meropenem and cefepime work in patients' bodies. Iohexol is used as a reference to measure kidney function accurately.
What are the potential side effects?
Iohexol may cause side effects such as allergic reactions, nausea, vomiting, headache, or dizziness. Kidney function will be closely monitored due to the critical condition of participants.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1-2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-2
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Akaike's information criterion (AIC) of cefepime
Akaike's information criterion (AIC) of iohexol
Akaike's information criterion (AIC) of meropenem
+3 moreSecondary study objectives
Pharmacokinetic/pharmacodynamics (PK/PD) optimized meropenem and cefepime dosing schemes
Side effects data
From 2016 Phase 4 trial • 72 Patients • NCT0224699831%
DIARRHOEA
19%
GONORRHOEA
19%
NASOPHARYNGITIS
19%
OCULAR ICTERUS
13%
RASH
13%
NAUSEA
13%
JAUNDICE
13%
BLOOD CREATINE PHOSPHOKINASE INCREASED
6%
DEPRESSED MOOD
6%
SPIDER VEIN
6%
NASAL CONGESTION
6%
HEAD DISCOMFORT
6%
DIZZINESS
6%
HYPOTENSION
6%
TERMINAL INSOMNIA
6%
OVERDOSE
6%
FATIGUE
6%
INFLUENZA LIKE ILLNESS
6%
ANAL CHLAMYDIA INFECTION
6%
EYE ABSCESS
6%
ONYCHOMYCOSIS
6%
RESPIRATORY TRACT INFECTION
6%
UPPER RESPIRATORY TRACT INFECTION
6%
ACUTE KIDNEY INJURY
6%
LIVER FUNCTION TEST ABNORMAL
6%
HEADACHE
6%
DYSPEPSIA
6%
INCREASED APPETITE
6%
PYREXIA
6%
LIVER INJURY
6%
LETHARGY
6%
ABNORMAL BEHAVIOUR
100%
80%
60%
40%
20%
0%
Study treatment Arm
TVD + ATV/r + Iohexol
ATR + Iohexol
ABC/3TC + ATV/r + Iohexol
STB + Iohexol
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
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.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1Experimental Treatment1 Intervention
Adult patients in the ICU receiving either meropenem or cefepime as part of their clinical management will receive one dose of IV iohexol 1500 mgI (5 mL) via slow push administration on Study Days 1 and 2 prior to the start of first or second daily meropenem or cefepime dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iohexol
2016
Completed Phase 4
~1920
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,327 Previous Clinical Trials
5,365,839 Total Patients Enrolled