Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ATM-AVI · 4 trials · 6 indications
Clinical cure was defined as improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally, for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by the Independent Clinical Adjudication Committee. 95% confidence interval (CI) was based on Jeffrey's method.
Clinical cure = improvement in baseline signs and symptoms such that after study treatment, no further antimicrobial treatment for the index infection (i.e., cIAI or HAP/VAP) was required. Additionally for cIAI participants, no unplanned drainage or surgical intervention was necessary since the initial procedure. Clinical cure was determined by Independent Clinical Adjudication Committee. 95% CI was based on Jeffrey's method. CE analysis set:all participants in ITT analysis set; met criteria for cIAI, or HAP/VAP; received at least 48 hours of study treatment or \<48 hours of treatment before discontinuing study drug due to AE; no concomitant antibiotics for any baseline pathogens between first dose and TOC (except protocol-allowed antibiotics); no prior antibiotics other than allowed per protocol; no important protocol deviations; no clinical outcome of indeterminate at TOC; no monomicrobial infections due to non-eligible pathogens and did not have only Gram-positive pathogens.
Cmax is the maximum plasma concentration of ATM and AVI as population pharmacokinetic (popPK) analysis predicts.
AUC is a measure of the plasma concentration of ATM and AVI overtime as popPK analysis predicts.
Half-life is the time measured for the plasma concentration of ATM and AVI to decrease by one half as popPK analysis predicts.
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 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 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 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 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 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 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.
Cmin is the minimum trough plasma concentration of ATM and AVI as popPK analysis predicts.
Half-life is the time measured for the plasma concentration of ATM and AVI to decrease by one half as popPK analysis predicts.
Proportion of Participants reporting AEs leading to discontinuation 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 liver injury and acute kidney injury of ATM-AVI relative to Best Available Therapy (BAT) 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
All participants were to have sparse pharmacokinetics (PK) sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above lower limit of quantification (LLOQ). LLOQ for ATM was 0.1 microgram per milliliter (mcg/ml).
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 nanogram per milliliter (ng/ml).
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for ATM was 0.1 mcg/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
All participants were to have sparse PK sampling on Day 1; the first sequentially enrolled 25 participants in study were to have intensive PK sampling on Day 4 while the remaining participants were to have sparse sampling on Day 4. Data was summarized only for observations above LLOQ. LLOQ for AVI was 10 ng/ml.
AUC(0-6) was defined as the area under the plasma concentration-time curve from time zero up to the six hours postdose.
AUC(0-6) was defined as the area under the plasma concentration-time curve from time zero up to the six hours postdose.
AUC(0-last) was defined as the area under the plasma concentration-time curve from time zero up to the time of the last measurable concentration.
AUC(0-last) was defined as the area under the plasma concentration-time curve from time zero up to the time of the last measurable concentration.
Plasma elimination half-life was defined as time measured for the plasma concentration of ATM and AVI to decrease by one half of its initial concentration.
Apparent volume of distribution at steady state was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Clearance of a drug was measure of the rate at which a drug was metabolized or eliminated by normal biological processes.
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAEs was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; or was an important medical event which may jeopardise the participants or require medical intervention to prevent one of the above outcomes. Treatment-emergent were events between first infusion of study drug and up to late follow-up (LFU) visit (20 to 24 days after last infusion). AEs included both non-serious AEs and SAEs.
Criteria for ECG abnormalities: QT value: greater than or equal to (\>=) 450 milliseconds (msec), \>=480 msec, \>=500 msec, \>=500 and increase from baseline \>=60 msec. Increase from baseline in QT: \>=30 msec, \>=60 msec. Decrease from baseline in QT: \>=30 msec, \>=60 msec. QTcB value: \>=450 msec, \>=480 msec, \>=500 msec, \>=500 and increase from baseline \>=60 msec. Increase from baseline in QT interval using Bazett's correction (QTcB) value: \>=30 msec, \>=60 msec. Decrease from baseline in QTcB: \>=30 msec, \>=60 msec. QT interval using Fridericia's correction (QTcF) value: \>=450 msec, \>=480 msec, \>=500 msec, \>=500 and increase from baseline \>=60 msec. Increase from baseline in QTcF value: \>=30 msec, \>=60 msec. Decrease from baseline in QTcF value: \>=30 msec, \>=60 msec. EOT (end of treatment) visit occurred within 24 hours after last infusion.
Criteria for abnormality: Hemoglobin, hematocrit, erythrocytes less than(\<) 0.7\*lower limit of normal \[LLN\] and (\&) greater than (\>) 30 percent (%) below baseline \[BB\]; \>1.3\*upper limit of normal \[ULN\] \& \>30% above baseline \[AB\], leukocytes \<0.65\*LLN \& \>60% BB; \>1.6\* ULN \& \>100% AB; platelets \<0.65\*LLN \& \>50% BB; \>1.5\*ULN \& \>100% AB; neutrophils \<0.65\*LLN \& \>75% BB; \>1.6\*ULN \& \>100% AB, lymphocytes \<0.25\*LLN \& \>75%BB; \>1.5\*ULN \& \>100% AB, basophils, eosinophils, monocytes\>4.0\*ULN \& \>300% AB. LFU visit occurred within 20 to 24 days after last infusion.
Criteria for abnormality: aspartate aminotransferase, alanine aminotransferase \>3.0\*ULN \& \>100% AB, alkaline phosphatase \<0.5 \*LLN \& \>80% BB\&; \>3.0\*ULN \& \>100% AB; bilirubin \>1.5\*ULN \& \>100% AB; direct bilirubin \>2.0\*ULN \& \>150% AB; protein \<0.5\*LLN \& \>50%BB; \>1.5\*ULN \& \>50% AB, albumin \<0.5\*LLN \& \>50% BB; \>1.5\*ULN \& \>50% AB, urea nitrogen \<0.2\* LLN \& \>100% BB; \>3.0\*ULN \& \>200% AB, creatinine \>2.0\*ULN \& \>100% AB, sodium \<0.85\*LLN \& \>10% BB;\>1.1\*ULN \&\>10% AB; potassium \<0.8\*LLN \&\>20% BB; \>1.2\*ULN \&\>20% AB, chloride \<0.8\*LLN \&\>20% BB;\>1.2\*ULN \& \>20% AB, calcium \<0.7\*LLN \& \>30% BB; \>1.3\*ULN \& \>30% AB, phosphate \<0.5\*LLN \& \>50% BB; \>3.0\*ULN \& \>200% AB, bicarbonate \<0.7\*LLN \& \>40% BB; \>1.3\*ULN \& \>40% AB, glucose \<0.6\*LLN \& \>40% BB, \>3.0\*ULN \& \>200% AB. LFU visit occurred within 20 to 24 days after last infusion.
Vital sign parameters included: Supine systolic blood pressure (millimeters of mercury \[mmHg\]), Supine diastolic blood pressure (mmHg), Heart rate (beats per minute), Respiratory rate (breaths per minute) and body temperature (degree celsius). Criteria for clinical significance in vital signs was based on investigator's assessment. LFU visit occurred within 20 to 24 days after last infusion.
Physical examinations included an assessment of abdomen, cardiovascular, general appearance, head, eyes, ears, nose, lymph nodes, skin, musculoskeletal, neurological, respiratory systems and other (edemas). Clinically significant abnormality in physical examination was based on investigator's assessment. LFU visit occured within 20 to 24 days after last infusion.
| Arm | Type | Description |
|---|---|---|
| Aztreonam-Avibactam ± Metronidazole | EXPERIMENTAL | All patients randomised to this arm will receive ATM-AVI; all patients with cIAI will receive MTZ for anaerobic cover |
| Meropenem ± Colistin | ACTIVE_COMPARATOR | All patients randomised to this arm will receive MER; addition of COL will be at investigator's discretion in line with local practice |
| Part A, Cohorts 1-4 | EXPERIMENTAL | Single dose pharmacokinetics. |
| Part B, Cohorts 1-4 | EXPERIMENTAL | Multi-dose pharmacokinetics and treatment |
| ATM-AVI | EXPERIMENTAL | ATM-AVI administered iv every 6 or 8 hours and dosed according to participant's weight and kidney function for up to 14 days depending on response. At the investigator's discretion, the participant may be switched to oral therapy after 3 days of iv ATM-AVI therapy |
| Best available therapy (BAT) | ACTIVE_COMPARATOR | BAT will be selected by the investigator and administered iv. At the investigator's discretion, the participant may be switched to oral therapy after 3 days of iv BAT |
| ATM-AVI + Metronidazole | EXPERIMENTAL | Aztreonam-avibactam + metronidazole |
| Name | Type | Description |
|---|---|---|
| ATM-AVI | DRUG | (Creatinine clearance \> 50 mL/min) 6500 mg ATM/2167 mg (loading dose, extended loading dose and maintenance dose) by iv infusion on Day 1 followed by a total daily dose of 6000 mg ATM/2000 mg AVI (Creatinine clearance 31 - 50 mL/min) 4250 mg ATM/1417 mg AVI on Day 1 (loading dose, extended loading dose, maintenance dose) followed by total daily dose 3000 mg ATM/1000 mg AVI (Creatinine clearance 16 - 30 mL/min) 2700 mg ATM/900 mg AVI on Day 1 (loading dose, extended loading dose maintenance dose), followed by total daily dose 2025 mg ATM/675 mg AVI |
| MTZ | DRUG | For cIAI only; 500 mg/100 mL metronidazole iv infusion over 1hr q8h |
| MER | DRUG | Where pathogen initially not suspected of being MER-resistant: (Creatinine clearance \> 50 mL/min) 1000 mg meropenem by 30 min iv infusion q8h (Creatinine clearance 26 - 50 mL/min) 1000mg meropenem by 30 min iv infusion q12h (Creatinine clearance 16 - 25 mL/min) 500 mg meropenem by 30 min iv infusion q12h Where pathogen initially suspected of being MER-resistant (Creatinine clearance \> 50 mL/min) 2000 mg meropenem by 180 min iv infusion q8h (Creatinine clearance 26 - 50 mL/min) 2000 mg meropenem by 180 min iv infusion q12h (Creatinine clearance 16 - 25 mL/min) 1000 mg meropenem by 180 min iv infusion q12h |
| COL | DRUG | Loading dose 9 million IU by 30 -60 min iv infusion (6 million IU where weight \< 60 kg) followed by one of the following maintenance doses: (Creatinine clearance \> 50 mL/min) after a 12h interval, commence maintenance dosing 9 million IU daily in 2 or 3 divided doses by 30 -60 min iv infusions. (Creatinine clearance 31 - 50 mL/min) After a 24 hr interval, commence maintenance dosing of 6 million IU daily in 2 divided doses by 30 -60 min iv infusion (Creatinine clearance 21 - 30 mL/min) After a 24 hr interval, commence maintenance dosing 5 million IU daily in 2 divided doses by 30 -60 min iv infusion (Creatinine clearance 16 - 20 mL/min) after a 24 hr interval, commence maintenance dosing 4 million IU daily in 2 divided doses by 30 -60 min iv infusion |
| 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. |
| BAT | DRUG | BAT will be selected by the investigator and administered iv as appropriate for the selected drug(s) |
| Metronidazole | DRUG | Metronidazole 500mg infused over 1 hour every 8 hours |
Inclusion Criteria: All subjects: 1. Male or female from 18 years of age 2. Provision of informed consent 3. Confirmed diagnosis of HAP/VAP or cIAI requiring iv antibiotic treatment 4. Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance s...
ATM-AVI is an investigational antibiotic combination of aztreonam and avibactam being developed by Pfizer for serious Gram-negative bacterial infections. It is a small molecule therapy studied in hospitalized patients, including adults, infants, and newborns, and is designed to treat infections caused by Gram-negative bacteria. It is not yet approved and remains in clinical development.
ATM-AVI is being studied for the treatment of complicated intra-abdominal infections, or cIAIs, in hospitalized adults. It has also been evaluated in serious Gram-negative infections including hospital acquired pneumonia and ventilator associated pneumonia. The program targets infections caused by Gram-negative bacteria, a group that includes multidrug-resistant pathogens.
ATM-AVI is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsors the clinical trial program evaluating the aztreonam-avibactam combination across adult and pediatric populations. The asset sits within Pfizer's infectious disease portfolio.
ATM-AVI is in Phase 2 development, with active Phase 2 trials currently recruiting. A completed Phase 3 trial, NCT03329092, evaluated aztreonam-avibactam with or without metronidazole versus meropenem with or without colistin in 422 adults with serious Gram-negative infections. ATM-AVI is investigational and has not been approved by the FDA.
Two active Phase 2 trials are recruiting. NCT06462235, called CHERISH, studies ATM-AVI in infants and newborns hospitalized with bacterial infection across the United States, Argentina, Bulgaria, Greece, India, Israel, Italy, Spain, and Taiwan. NCT05639647 compares aztreonam and avibactam to best available therapy for serious Gram-negative infections in patients as young as 9 months.
Yes, Part A: ATM-AVI Single Dose, Cohorts 1-4 refers to the same aztreonam-avibactam combination, abbreviated ATM-AVI. The longer name describes a single-dose portion of the pediatric study design, where cohorts of infants and newborns receive one dose of the study medicine. Both names point to the same Pfizer investigational antibiotic asset.