RecruitingPhase 2

A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)

United States, Argentina, India48 participantsStarted 2024-09-25

Plain-language summary

The purpose of this study is to learn about the safety and effects of ATM-AVI for the possible treatment of infections caused by a type of bacteria called gram-negative bacteria. The study medicine is a combination of an antibiotic, aztreonam (ATM), and another medicine, avibactam (AVI), which is used to help stop bacteria from being resistant to antibiotics. Antibiotics are medicines that fights bacteria and infections. The study will include newborns and infants up to 9 months of age who are admitted in the hospital. The study is conducted in 2 parts: Part A and Part B. In Part A, all participants will receive a single intravenous (injected directly into a vein) infusion of ATM-AVI. This is to study the safety and effects of a single amount. In Part B, all participants will receive multiple intravenous infusions of ATM-AVI as treatment for a possible or confirmed infection with gram-negative bacteria.

Who can participate

Age range

39 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Hospitalized with age from birth \<9 months, including preterm birth
. Part A: Receiving IV antibiotics for treatment of suspected or confirmed bacterial infection, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
. Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
. Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment.
. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI

Timeframe: Up to Day 15

Area under the Concentration-Time Curve (AUC) of ATM-AVI

Timeframe: Up to Day 15

Plasma Elimination Half-Life (t1/2)

Timeframe: Up to Day 15

Apparent Clearance (CL)

Timeframe: Up to Day 15

Plasma concentrations of ATM and AVI by nominal sampling time

Timeframe: Up to Day 15

Proportion of Participants reporting Adverse Events (AE)

Timeframe: Baseline up to Day 50

Proportion of Participants reporting Serious Adverse Events (SAE)

Timeframe: Baseline up to Day 50

Trial details

NCT IDNCT06462235

SponsorPfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-25

Contact for this trial

Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

View on ClinicalTrials.gov More Gram-negative Bacterial Infection trials

Plain-language summary

Who can participate

Age range

39 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Hospitalized with age from birth \<9 months, including preterm birth
. Part A: Receiving IV antibiotics for treatment of suspected or confirmed bacterial infection, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
. Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis.
. Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment.
. Any medical or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
. 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.

What they're measuring

Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI

Timeframe: Up to Day 15

Area under the Concentration-Time Curve (AUC) of ATM-AVI

Timeframe: Up to Day 15

Plasma Elimination Half-Life (t1/2)

Timeframe: Up to Day 15

Apparent Clearance (CL)

Timeframe: Up to Day 15

Plasma concentrations of ATM and AVI by nominal sampling time

Timeframe: Up to Day 15

Proportion of Participants reporting Adverse Events (AE)

Timeframe: Baseline up to Day 50

Proportion of Participants reporting Serious Adverse Events (SAE)

Timeframe: Baseline up to Day 50