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Anti-bacterial

ATM-AVI for Bacterial Infections in Infants (CHERISH Trial)

Phase 2
Recruiting
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
Severe renal impairment or known significant renal disease, as evidenced by elevated serum creatinine at screening, or urinary output <0.5 mL/kg/h for 6 consecutive hours or requirement for dialysis.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7-14 days after the last study treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test the safety and effectiveness of a new medication called ATM-AVI for treating infections caused by a type of bacteria called gram-negative bacteria. The medication is a combination of two drugs,

Who is the study for?
The CHERISH trial is for hospitalized newborns and infants up to 9 months old, including preterm babies. It's for those with suspected or confirmed bacterial infections caused by gram-negative bacteria. Babies already on antibiotics for over 24 hours may join Part B unless they're not improving after 48 hours of treatment.
What is being tested?
This study tests ATM-AVI, a combination antibiotic therapy given via IV (in the vein). Part A involves a single dose to check safety and effects, while Part B gives multiple doses to treat actual infections.
What are the potential side effects?
Potential side effects aren't detailed here but can include typical antibiotic reactions such as allergic responses, digestive upset, rash, or changes in blood tests that monitor liver and kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have severe kidney problems or need dialysis.
Select...
I am currently on IV antibiotics for a suspected or confirmed bacterial infection.
Select...
My baby is hospitalized and under 9 months old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7-14 days after the last study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7-14 days after the last study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apparent Clearance (CL)
Area under the Concentration-Time Curve (AUC) of ATM-AVI
Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI
+7 more
Secondary study objectives
Part B: Counts and proportions of participants with emergent infections (new infections or superinfections) during the study
Part B: Counts and proportions of pathogens with each per-pathogen microbiological response at EOIV/EOT
Part B: Counts and proportions of pathogens with each per-pathogen microbiological response at TOC
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B, Cohorts 1-4Experimental Treatment1 Intervention
Multi-dose pharmacokinetics and treatment
Group II: Part A, Cohorts 1-4Experimental Treatment1 Intervention
Single dose pharmacokinetics.

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,646 Previous Clinical Trials
17,743,463 Total Patients Enrolled
AbbVieIndustry Sponsor
1,017 Previous Clinical Trials
519,987 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,534 Previous Clinical Trials
14,914,830 Total Patients Enrolled
~32 spots leftby Sep 2027
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