A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.

Completed · Phase 3

Conditions studied: Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia, Ventilator Associated Pneumonia

In brief

A Phase 3 comparative study to determine the efficacy, safety and tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) versus Meropenem (MER) ± Colistin (COL) for the treatment of serious infections due to Gram negative bacteria.

Key facts

Study ID

NCT03329092

Run by

Pfizer

People needed

422

Starts

2018-04-05

Expected to finish

2023-02-23

Last updated by the study team

2024-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All subjects:
• Male or female from 18 years of age
• Provision of informed consent
• Confirmed diagnosis of HAP/VAP or cIAI requiring iv antibiotic treatment
• Female patients are authorized to participate in this clinical study if criteria concerning pregnancy avoidance stated in the protocol are met and negative pregnancy test
• Additional for cIAI:
• Diagnosis of cIAI, EITHER:
• Intra-operative/postoperative enrolment with visual confirmation of cIAI. OR Preoperative enrollment with evidence of systemic inflammatory response, physical and radiological findings consistent with cIAI; confirmation of cIAI at time of surgery within 24 hours of study entry
• Surgical intervention within 24 hours (before or after) the administration of the first dose of study drug
• Additional for HAP/VAP:
• Onset symptoms > 48h after admission to or <7 days after discharge from an inpatient care facility
• New or worsening infiltrate on CXR or CT scan
• Clinical signs and symptoms and laboratory findings consistent with HAP/VAP
• Respiratory specimen obtained for Gram stain and culture following onset of symptoms and prior to randomisation

You may not qualify if…

• All subjects:
• APACHE II score > 30
• Confirmed or suspected infection caused by Gram-negative species not expected to respond to study drug, or Gram-positive species
• Receipt of >24 hr systemic antibiotic within 48h prior to randomisation (exception in case of treatment failure)
• History of serious allergy, hypersensitivity (eg, anaphylaxis), or any serious reaction to aztreonam, carbapenem,monobactam or other β-lactam antibiotics, avibactam, nitroimidazoles or metronidazole, or any of the excipients of the study drugs
• Known Clostridium difficle associated diarrhoea
• Requirement for effective concomitant systemic antibacterials or antifungals
• Creatinine clearance ≤15 ml/min or requirement or expectation for renal replacement therapy
• Acute hepatitis, cirrhosis, acute hepatic failure, chronic hepatic failure
• Hepatic disease as indicated by AST or ALT >3 × ULN. Patients with AST and/or ALT up to 5 × ULN are eligible if acute and documented by the investigator as being directly related infectious process
• Patient has a total bilirubin >2 × ULN, unless isolated hyperbilirubinemia is directly related to infectious process or due to known Gilbert's disease
• ALP >3 × ULN. Patients with values >3 × ULN and <5 x ULN are eligible if acute and directly related to the infectious process being treated
• Absolute neutrophil count <500/mm3
• Pregnant or breastfeeding or if of child bearing potential, not using a medically accepted effective method of birth control.
• Any other condition that may confound the results of the study or pose additional risks to the subject
• Unlikely to comply with protocol
• History of epilepsy or seizure disorders excluding febrile seizures of childhood
• Additional for cIAI
• Diagnosis of abdominal wall abscess; small bowel obstruction or ischemic bowel disease without perforation; traumatic bowel perforation with surgery within 12 hours of diagnosis; perforation of gastroduodenal ulcer with surgery < 24 hours of diagnosis primary etiology is not likely to be infectious
• Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess
• Prior liver, pancreas or small-bowel transplant
• Staged abdominal repair (STAR), open abdomen technique or marsupialisation
• Additional for HAP/VAP
• APACHE II score < 10
• Known or high likelihood of Gram-positive monomicrobial infection

Where it is running

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Memorial Medical Center — Springfield, Illinois, United States
• Sanatorio Britanico — Rosario, Santa Fe Province, Argentina
• Sanatorio Servicios Medicos SM — Santo Tomé, Santa Fe Province, Argentina
• Hospital San Roque — Córdoba, Argentina
• University Hospital Alexandrovska, Clinic of Anesthesiology and Intensive Care — Sofia, Bulgaria
• University Hospital Queen Joanna ISUL, Clinic of Surgery — Sofia, Bulgaria
• University Multiprofile Hospital for Active Treatment ''Prof.Dr Stoyan Kirkovich''AD — Stara Zagora, Bulgaria
• Peking University Third Hospital — Beijing, Beijing Municipality, China
• Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou, Fujian, China
• ZhuJiang Hospital of Southern Medical University — Guangzhou, Guangdong, China
• The First Affiliated Hospital of Shantou University Medical College — Shantou, Guangdong, China
• The Second People's Hospital of Shenzhen — Shenzhen, Guangdong, China
• Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China
• Nanning First People's Hospital — Nanning, Guangxi, China
• Changsha Third Hospital — Changsha, Hunan, China
• Hunan Province People's Hospital — Changsha, Hunan, China
• Baotou Central Hospital — Baotou, Inner Mongolia, China
• Jiangyin People's Hospital — Jiangyin, Jiangsu, China
• Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China
• Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China
• Banner University Medical Center - Tucson — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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