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.

  • STATUS
    Recruiting
  • End date
    Dec 14, 2022
  • participants needed
    375
  • sponsor
    Pfizer
Updated on 30 November 2021
ct scan
antibiotic therapy
antibiotics
metronidazole
colistin
chest x-ray
meropenem
ATM

Summary

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.

Description

A Phase 3 Prospective, Randomized, Multicenter, Open Label, Central Assessor Blinded, Parallel Group, Comparative Study To Determine The Efficacy, Safety And Tolerability Of Aztreonam-Avibactam (ATM-AVI) Metronidazole (MTZ) Versus MeropenemColistin (MERCOL) For The Treatment Of Serious Infections Due To Gram Negative Bacteria, Including Metallo Lactamase (MBL) - Producing Multidrug Resistant Pathogens, For Which There Are Limited Or No Treatment Options

Details
Condition Pneumonia, Ventilator associated pneumonia, Pneumonia (Pediatric), Complicated Intra-abdominal Infection, Hosptial Acquired Pneumonia, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, ventilator-associated pneumonia, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection, Complicated Intra-abdominal Infection
Treatment ATM-AVI, MER, MTZ, COL, COL
Clinical Study IdentifierNCT03329092
SponsorPfizer
Last Modified on30 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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 -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
Lung abscess, pleural empyema, post-obstructive pneumonia
Lung or heart transplant
Myasthenia gravis
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