--- title: A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH) nct_id: NCT06462235 overall_status: RECRUITING phase: PHASE2 sponsor: Pfizer study_type: INTERVENTIONAL primary_condition: Gram-negative Bacterial Infection countries: United States, Argentina, India, Israel, Taiwan canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06462235.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06462235" ct_last_update_post_date: 2026-05-05 last_seen_at: "2026-05-12T07:34:40.176Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH) **Official Title:** A PHASE 2A, 2-PART, OPEN-LABEL, NON-RANDOMIZED, MULTICENTER, SINGLE AND MULTIPLE DOSE TRIAL TO EVALUATE PHARMACOKINETICS, SAFETY AND TOLERABILITY OF AZTREONAM AND AVIBACTAM ± METRONIDAZOLE IN NEONATES AND INFANTS FROM BIRTH TO LESS THAN 9 MONTHS OF AGE WITH SUSPECTED OR CONFIRMED INFECTIONS DUE TO GRAM-NEGATIVE PATHOGENS REQUIRING INTRAVENOUS ANTIBIOTIC TREATMENT **NCT ID:** [NCT06462235](https://clinicaltrials.gov/study/NCT06462235) ## Key Facts - **Status:** RECRUITING - **Phase:** PHASE2 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 48 - **Lead Sponsor:** Pfizer - **Collaborators:** AbbVie - **Conditions:** Gram-negative Bacterial Infection - **Start Date:** 2024-09-25 - **Completion Date:** 2027-04-25 - **CT.gov Last Update:** 2026-05-05 ## Brief 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. ## Detailed Description This is a 2-part Phase 2a, non-randomized, multicenter, open-label, single and multi-dose study to assess pharmacokinetics (PK), safety, and tolerability of ATM-AVI in hospitalized neonates and infants aged birth, including preterm birth, to \<9 months. A total of 48 participants will be enrolled in 4 age cohorts of 12 each, 6 Part A and 6 Part B. Part A will begin enrolling before Part B and no infant may participate in both parts. Cohort 1 will include full term infants age ≥13 weeks to \<39 weeks and preterm infants postmenstrual age ≥50 weeks to \<75 weeks. Cohort 2 will include full term infants age ≥28 weeks to \<13 weeks and preterm infants postmenstrual age ≥40 weeks to \<50 weeks and ≥28 days of age. Cohort 3 will include full term infants age birth to \<28 days. Cohort 4 will include preterm infants age birth to \<28 days or postmenstrual age \<40 weeks. Participants in Part A must be hospitalized and receiving intravenous antibiotic treatment for a suspected or confirmed bacterial infection. Participants will receive a single 3 hour intravenous infusion of ATM-AVI and have 3 ATM-AVI blood level assessments during and up to 5 hour after the infusion. Participants will be observed for 48 hours following the infusion to assess safety and toleration and will have a final follow-up safety assessment which may be conducted by telephone 4-5 weeks following the infusion. The single infusion of ATM-AVI is administered to assess the safety, tolerability, and pharmacokinetics of a single dose of ATM-AVI and is not intended as treatment for the bacterial infection. The total duration of study participation in Part A is expected to be 5 weeks through the end of the final safety follow-up. Participants in Part B must be hospitalized with suspected or confirmed aerobic gram-negative bacterial infection requiring intravenous antibacterial therapy. Part B participants will receive multiple 3 hour intravenous infusions of ATM-AVI every 6 hour (8 hours for preterm infants) for 3-14 days as treatment for their bacterial infection and to assess ATM-AVI pharmacokinetics, safety, tolerability, and efficacy. Participants with complicated intra-abdominal infection (cIAI) will also receive intravenous metronidazole and all participants will have the option to receive other intravenous antibiotic treatment for gram-positive bacteria, as appropriate. Participants who have a good clinical response after 72 hours of intravenous ATM-AVI treatment may be switched to a different orally administered antibiotic, if clinically appropriate. Part B participants will have a total of 5 ATM-AVI blood level assessments over the first 2 or more days following the start of ATM-AVI infusions and will have their clinical response assessed at the End of Treatment (intravenous and oral, if applicable), and at a Test-of-Cure (TOC) evaluation 7 to 14 days after the last antibiotic treatment (intravenous or oral). A final safety assessment which may be conducted by telephone will occur 4-5 weeks after the last dose of ATM-AVI. The total duration of study participation in Part B is expected to be up to 7 weeks through the end of the final safety follow-up. Additional safety monitoring will be provided by an independent external Data Monitoring Committee (DMC). Enrollment for the study will begin with Part A, single dose, cohorts 1-3. Part A Cohort 4 (preterm neonates) will commence enrollment after sponsor and DMC review of plasma drug levels and safety for a least 2 participants in Part A Cohort 3 and review of ATM-AVI safety and tolerability for all participants enrolled at that time. Enrollment in the multidose Part B cohorts will be delayed until preliminary information is obtained regarding ATM-AVI multidose safety, tolerability, and drug levels for the participants 9 months to 2 years of age in the separate ongoing ATM-AVI pediatric study C3601008 \[NCT05639647\]. ## Eligibility - **Maximum age:** 39 Weeks - **Sex:** ALL - **Healthy Volunteers:** No ``` Inclusion Criteria Participants must meet the following key inclusion criteria to be eligible for enrollment into the study: 1. Hospitalized with age from birth \<9 months, including preterm birth 2. 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. 3. Part B: Suspected or confirmed gram-negative bacterial infection requiring IV antibiotics, including but not limited to cIAI, cUTI, HAP/VAP, BSI, or sepsis. Participants with any of the following characteristics/conditions will be excluded: 1. Received any other investigational medicinal product within the longer of 30 days or 5 half-lives before enrollment. 2. 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. 3. 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. 4. Part B Only: Received \>24 hours of systemic antibiotic treatment for gram-negative organisms at time of enrollment, unless documented treatment failure or lack of improvement in at least one objective sign or symptom of infection after ≥48 hours of antibiotics. ``` ## Arms - **Part A, Cohorts 1-4** (EXPERIMENTAL) — Single dose pharmacokinetics. - **Part B, Cohorts 1-4** (EXPERIMENTAL) — Multi-dose pharmacokinetics and treatment ## Interventions - **Part A: ATM-AVI Single Dose, Cohorts 1-4** (DRUG) — Single intravenous infusion of aztreonam-avibactam over 3 hours to assess pharmacokinetics, safety, and toleration. - **Part B: Multiple-dose ATM-AVI, Cohorts 1-4** (DRUG) — Multiple intravenous infusions of aztreonam-avibactam over 3 hours, repeated every 6-8 hours up to 14 days to assess pharmacokinetics, safety, toleration, and efficacy. ## Primary Outcomes - **Maximum Predicted Plasma Concentration (Cmax) of ATM and AVI** _(time frame: Up to Day 15)_ — Cmax is the maximum plasma concentration of ATM and AVI as population pharmacokinetic (popPK) analysis predicts. - **Area under the Concentration-Time Curve (AUC) of ATM-AVI** _(time frame: Up to Day 15)_ — AUC is a measure of the plasma concentration of ATM and AVI overtime as popPK analysis predicts. - **Plasma Elimination Half-Life (t1/2)** _(time frame: Up to Day 15)_ — Half-life is the time measured for the plasma concentration of ATM and AVI to decrease by one half as popPK analysis predicts. - **Apparent Clearance (CL)** _(time frame: Up to Day 15)_ — ATM and AVI clearance is a quantitative measure of the rate at which ATM and AVI are removed from the blood (rate at which ATM and AVI are metabolized or eliminated by normal biological processes). Clearance obtained after intravenous infusion dose (apparent clearance) is influenced by the fraction of the dose absorbed. - **Plasma concentrations of ATM and AVI by nominal sampling time** _(time frame: Up to Day 15)_ — Plasma concentrations of ATM and AVI on Day 1 and at steady state (Day 2 or later) will be summarized by the nominal sampling time using descriptive statistics (eg number, mean, standard deviation). - **Proportion of Participants reporting Adverse Events (AE)** _(time frame: Baseline up to Day 50)_ — Proportion of participant AE reports of vital signs, physical examinations, and clinical laboratory tests overall and by age cohort. For each AE the last assessment made prior to the first dose of study drug will be defined as the baseline. - **Proportion of Participants reporting Serious Adverse Events (SAE)** _(time frame: Baseline up to Day 50)_ — Proportion of participant SAE reports of vital signs, physical examinations, and clinical laboratory tests overall and by age cohort. For each SAE the last assessment made prior to the first dose of study drug will be defined as the baseline. - **Proportion of Participants reporting AEs leading to discontinuation of study drug** _(time frame: Baseline up to Day 50)_ — Proportion of Participants reporting AEs leading to discontinuation of study drug from baseline. For each discontinuation the last assessment made prior to the first dose of study drug will be defined as the baseline. - **Proportion of Participants reporting AEs resulting in death** _(time frame: Baseline up to Day 50)_ — Proportion of Participants reporting AE resulting in death from baseline. For each death the last assessment made prior to the first dose of study drug will be defined as the baseline. - **Proportion of Participants reporting liver injury and acute kidney injury** _(time frame: Baseline up to Day 50)_ — Proportion of Participants reporting liver injury and acute kidney injury from baseline. For each report of liver and acute kidney injury the last assessment made prior to the first dose of study drug will be defined as the baseline. ## Secondary Outcomes - **Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at end of IV study treatment (EOIV)** _(time frame: Up to 15 days after start of IV study treatment)_ - **Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at end of treatment (EOT)** _(time frame: Within 48 hours after last dose of oral switch treatment)_ - **Part B: Proportion of participants with each clinical outcome and with a favorable clinical outcome at test of cure (TOC)** _(time frame: 7-14 days after the last study treatment)_ - **Part B: Proportion of participants with a favorable microbiological response at TOC** _(time frame: 7-14 days after the last study treatment)_ - **Part B: Counts and proportions of pathogens with each per-pathogen microbiological response at EOIV/EOT** _(time frame: Up to 15 days after start of IV study treatment)_ - **Part B: Counts and proportions of pathogens with each per-pathogen microbiological response at TOC** _(time frame: 7-14 days after the last study treatment)_ - **Part B: Counts and proportions of participants with emergent infections (new infections or superinfections) during the study** _(time frame: Through study completion, up to Day 50)_ ## Locations (29) - Children's Hospital of Orange County Southwest Tower, Orange, California, United States — _RECRUITING_ - Children's Hospital of Orange County, Orange, California, United States — _RECRUITING_ - Children's Hospital Colorado, Aurora, Colorado, United States — _RECRUITING_ - Riley Hospital for Children at Indiana University Health, Indianapolis, Indiana, United States — _RECRUITING_ - Norton Children's Hospital, Louisville, Kentucky, United States — _RECRUITING_ - Novak Center for Children's Health, Louisville, Kentucky, United States — _RECRUITING_ - University of Louisville, Norton Children's Research Institute, Louisville, Kentucky, United States — _RECRUITING_ - Tufts Medical Center, Boston, Massachusetts, United States — _RECRUITING_ - Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital, New Brunswick, New Jersey, United States — _RECRUITING_ - Rutgers University, New Brunswick, New Jersey, United States — _RECRUITING_ - Duke University - Main Hospital and Clinics, Durham, North Carolina, United States — _RECRUITING_ - Memorial Hermann Hospital - Texas Medical Center, Houston, Texas, United States — _RECRUITING_ - The University of Texas Health Science Center at Houston, Houston, Texas, United States — _RECRUITING_ - Sanatorio Sagrado Corazón, Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina — _RECRUITING_ - Clinica Del Niño Y La Madre, Mar del Plata, Buenos Aires, Argentina — _NOT_YET_RECRUITING_ - Clinica Privada del Sol S.A, Córdoba, Córdoba Province, Argentina — _RECRUITING_ - Hospital del Niño Jesús, San Miguel de Tucumán, Tucumán Province, Argentina — _RECRUITING_ - Nirmal Hospital Pvt Ltd., Surat, Gujarat, India — _RECRUITING_ - RajaRajeswari Medical College and Hospital, Bengaluru, Karnataka, India — _RECRUITING_ - Medanta Hospital Lucknow, Lucknow, Uttar Pradesh, India — _RECRUITING_ - Institute of Child Health, Kolkata, West Bengal, India — _RECRUITING_ - Schneider Children's Medical Center, Petah Tikva, Central District, Israel — _RECRUITING_ - Rambam Health Care Campus, Haifa, Northern District, Israel — _RECRUITING_ - Clalit Health Services through Schneider Children's Medical Center, Petah Tikva, Israel — _RECRUITING_ - Hsinchu Municipal Mackay Children's Hospital, Hsinchu, Hsinchu, Taiwan — _RECRUITING_ - Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Hualien City, Hualien, Taiwan — _RECRUITING_ - Taichung Veterans General Hospital, Taichung, Taiwan — _RECRUITING_ - National Taiwan University Hospital, Taipei, Taiwan — _RECRUITING_ - Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan — _RECRUITING_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `locations.novak center for children's health|louisville|kentucky|united states` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.children's hospital of orange county southwest tower|orange|california|united states` — added _(2026-05-12)_ - `locations.children's hospital of orange county|orange|california|united states` — added _(2026-05-12)_ - `locations.children's hospital colorado|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.riley hospital for children at indiana university health|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.norton children's hospital|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.university of louisville, norton children's research institute|louisville|kentucky|united states` — added _(2026-05-12)_ - `locations.tufts medical center|boston|massachusetts|united states` — added _(2026-05-12)_ - `locations.bristol myers squibb children's hospital at robert wood johnson university hospital|new brunswick|new jersey|united states` — added _(2026-05-12)_ - `locations.rutgers university|new brunswick|new jersey|united states` — added _(2026-05-12)_ - `locations.duke university - main hospital and clinics|durham|north carolina|united states` — added _(2026-05-12)_ - `locations.memorial hermann hospital - texas medical center|houston|texas|united states` — added _(2026-05-12)_ - `locations.the university of texas health science center at houston|houston|texas|united states` — added _(2026-05-12)_ - `locations.sanatorio sagrado corazón|ciudad autónoma de buenos aires|buenos aires|argentina` — added _(2026-05-12)_ - `locations.clinica del niño y la madre|mar del plata|buenos aires|argentina` — added _(2026-05-12)_ - `locations.clinica privada del sol s.a|córdoba|córdoba province|argentina` — added _(2026-05-12)_ - `locations.hospital del niño jesús|san miguel de tucumán|tucumán province|argentina` — added _(2026-05-12)_ - `locations.nirmal hospital pvt ltd.|surat|gujarat|india` — added _(2026-05-12)_ - `locations.rajarajeswari medical college and hospital|bengaluru|karnataka|india` — added _(2026-05-12)_ - `locations.medanta hospital lucknow|lucknow|uttar pradesh|india` — added _(2026-05-12)_ - `locations.institute of child health|kolkata|west bengal|india` — added _(2026-05-12)_ - `locations.schneider children's medical center|petah tikva|central district|israel` — added _(2026-05-12)_ - `locations.rambam health care campus|haifa|northern district|israel` — added _(2026-05-12)_ - `locations.clalit health services through schneider children's medical center|petah tikva||israel` — added _(2026-05-12)_ - `locations.hsinchu municipal mackay children's hospital|hsinchu|hsinchu|taiwan` — added _(2026-05-12)_ - `locations.hualien tzu chi hospital, buddhist tzu chi medical foundation|hualien city|hualien|taiwan` — added _(2026-05-12)_ - `locations.taichung veterans general hospital|taichung||taiwan` — added _(2026-05-12)_ - `locations.national taiwan university hospital|taipei||taiwan` — added _(2026-05-12)_ - `locations.chang gung medical foundation linkou chang gung memorial hospital|taoyuan||taiwan` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06462235.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06462235* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*