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.
REVISIT
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 MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS
3 other identifiers
interventional
422
21 countries
157
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2018
Longer than P75 for phase_3
157 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2017
CompletedFirst Posted
Study publicly available on registry
November 1, 2017
CompletedStudy Start
First participant enrolled
April 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2023
CompletedResults Posted
Study results publicly available
May 7, 2024
CompletedDecember 10, 2024
November 1, 2024
4.9 years
October 6, 2017
February 21, 2024
November 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Clinical Cure at Test of Cure (TOC) Visit: Intent-To-Treat (ITT) Analysis Set
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.
At TOC visit (Day 28)
Percentage of Participants With Clinical Cure at TOC Visit: Clinically Evaluable (CE) Analysis Set
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.
At TOC visit (Day 28)
Secondary Outcomes (30)
Percentage of Participants With Clinical Cure at TOC Visit: Microbiological Intent-To-Treat (Micro-ITT) Analysis Set
At TOC visit (Day 28)
Percentage of Participants With Clinical Cure at TOC Visit: Microbiologically Evaluable (ME) Analysis Set
At TOC visit (Day 28)
Percentage of Participants With Clinical Cure at TOC Visit by Type of Infection: ITT Analysis Set
At TOC visit (Day 28)
Percentage of Participants With Clinical Cure at TOC Visit by Type of Infection: CE Analysis Set
At TOC visit (Day 28)
Percentage of Participants With Clinical Cure in Participants With Metallo-beta-lactamase (MBL) Positive Pathogen at TOC Visit: Micro-ITT Analysis Set
At TOC visit (Day 28)
- +25 more secondary outcomes
Other Outcomes (40)
Percentage of Participants With Clinical Cure at End of Treatment (EOT) Visit: ITT Analysis Set
At EOT visit (Within 24 hours after last infusion on Day 14)
Percentage of Participants With Clinical Cure at EOT Visit: Micro-ITT Analysis Set
At EOT visit (Within 24 hours after last infusion on Day 14)
Percentage of Participants With Clinical Cure at EOT Visit: CE Analysis Set
At EOT visit (Within 24 hours after last infusion on Day 14)
- +37 more other outcomes
Study Arms (2)
Aztreonam-Avibactam ± Metronidazole
EXPERIMENTALAll patients randomised to this arm will receive ATM-AVI; all patients with cIAI will receive MTZ for anaerobic cover
Meropenem ± Colistin
ACTIVE COMPARATORAll patients randomised to this arm will receive MER; addition of COL will be at investigator's discretion in line with local practice
Interventions
(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
For cIAI only; 500 mg/100 mL metronidazole iv infusion over 1hr q8h
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
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
Eligibility Criteria
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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Innovative Medicines Initiativecollaborator
- Biomedical Advanced Research and Development Authoritycollaborator
Study Sites (157)
Banner University Medical Center - Tucson
Tucson, Arizona, 85719, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502, United States
Harbor-UCLA Medical Center
Torrance, California, 90509, United States
Southern Illinois University School of Medicine
Springfield, Illinois, 62702, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Sanatorio Britanico
Rosario, Santa Fe Province, 2000, Argentina
Sanatorio Servicios Medicos SM
Santo Tomé, Santa Fe Province, S3016, Argentina
Hospital San Roque
Córdoba, 5000, Argentina
University Hospital Alexandrovska, Clinic of Anesthesiology and Intensive Care
Sofia, 1431, Bulgaria
University Hospital Queen Joanna ISUL, Clinic of Surgery
Sofia, 1527, Bulgaria
University Multiprofile Hospital for Active Treatment ''Prof.Dr Stoyan Kirkovich''AD
Stara Zagora, 6003, Bulgaria
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363000, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541001, China
Nanning First People's Hospital
Nanning, Guangxi, 530022, China
Changsha Third Hospital
Changsha, Hunan, 410000, China
Hunan Province People's Hospital
Changsha, Hunan, 410005, China
Baotou Central Hospital
Baotou, Inner Mongolia, 014000, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, 214400, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433, China
The First people's Hospital of Kunming
Kunming, Yunnan, 650034, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Taizhou Hospital of Zhejiang Province
Linhai, Zhejiang, 317000, China
Lishui People's Hospital
Lishui, Zhejiang, 323000, China
Quzhou People's Hospital
Quzhou, Zhejiang, 324000, China
Peking University People's Hospital
Beijing, 100044, China
Jiangyin People's Hospital
Jiangyin, 214400, China
Tianjin Union Medical Center
Tianjin, 300000, China
Klinicka bolnica Merkur
Zagreb, City of Zagreb, 10000, Croatia
Klinicki bolnicki centar Rijeka
Rijeka, Primorje-Gorski Kotar County, 51000, Croatia
University Hospital Centre Osijek
Osijek, 31000, Croatia
General Hospital "Dr. Josip Bencevic" Slavonski Brod
Slavonski Brod, 35000, Croatia
Clinical Hospital Dubrava
Zagreb, 10000, Croatia
Fakultni nemocnice Brno
Brno, 625 00, Czechia
Krajska zdravotni, a.s. - Nemocnice Decin, o.z.
Děčín, 40599, Czechia
Lekarna Nemocnice Decin, Krajska zdravotni, a.s.- Nemocnice Decin, o.z.
Děčín, 40599, Czechia
Public Hospital Kolin, a.s.
Kolin III, 280 02, Czechia
Nemocnice Kyjov, prispevkova organizace
Kyjov, 697 01, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
General Hospital of Athens "Evangelismos"
Athens, 10676, Greece
General and Chest Diseases Hospital "Sotiria"
Athens, 11527, Greece
General Hospital of Athens "Laiko"
Athens, 11527, Greece
University General Hospital "ATTIKON"
Athens, 12462, Greece
University General Hospital of Heraklion
Heraklion, Crete, 71110, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
Koutlimbaneio and Triantafylleio General Hospital of Larissa
Larissa, 41221, Greece
King George Hospital
Visakhapatnam, Andhra Pradesh, 530002, India
Victoria Hospital, Bangalore Medical College and Research Institute
Bangalore, Karnataka, 560002, India
M S Ramaiah Medical College and Hospitals
Bangalore, Karnataka, 560054, India
Kasturba Medical College and Hospital
Manipal, Karnataka, 576104, India
JSS Hospital
Mysuru, Karnataka, 570004, India
Amrita Institute of Medical Sciences & Research Centre
Kochi, Kerala, 682041, India
Government Medical College, Kozhikode
Kozhikode, Kerala, 673008, India
Deenanath Mangeshkar Hospital And Research Centre
Pune, Maharashtra, 411004, India
Sahyadri Super Speciality Hospital
Pune, Maharashtra, 411004, India
Sahyadri Super Specialty Hospital
Pune, Maharashtra, 411004, India
S.R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001, India
Apollo Hospitals
Chennai, Tamil Nadu, 600006, India
King George's Medical University
Lucknow, Uttar Pradesh, 226003, India
Dayanand Medical College and Hospital
Ludhiana, 141001, India
Sahyadri Clinical Research & Development Center
Pune, 411004, India
Sahyadri Specialty Hospital
Pune, India
Assuta Ashdod University Hospital
Ashdod, 7747629, Israel
Rambam Health Care Campus
Haifa, 3109601, Israel
Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
Jerusalem, 9112001, Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 5265601, Israel
Shamir Medical Center, Infectious Diseases Unit
Ẕerifin, 7030000, Israel
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Milan, 20122, Italy
Azienda Ospedaliero-Universitaria Ospedali Riuniti
Foggia, 71122, Italy
Azienda Ospedaliero Universitaria di Modena
Modena, 41124, Italy
Farmacia Ospedaliera - Direzione Assistenza Farmaceutica
Modena, 41124, Italy
SC di Radiologia - Azienda Ospedaliera Universitaria di Modena
Modena, 41124, Italy
Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello
Pisa, 56100, Italy
UO Radiognastostica 2 Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello
Pisa, 56100, Italy
UO Farmaceutica Azienda Ospedaliero-Universitaria Pisana
Pisa, 56126, Italy
Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa
Udine, 33100, Italy
Hospital Seberang Jaya
Seberang Jaya, Pulau Pinang, 13700, Malaysia
Hospital Sultanah Nur Zahirah
Kuala Terengganu, Terengganu, 20400, Malaysia
University Malaya Medical Centre
Kuala Lumpur, 59100, Malaysia
Hospital Civil Fray Antonio Alcalde
Guadalajara, Jalisco, 44280, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
De La Salle Medical and Health Sciences Institute
City of Dasmarinas, Cavite, 4114, Philippines
Baguio General Hospital and Medical Center
Baguio City, 2600, Philippines
Asian Hospital and Medical Center
City of Muntinlupa, 1780, Philippines
Davao Doctors Hospital
Davao City, 8000, Philippines
St. Paul's Hospital of Iloilo, Inc.
Iloilo City, 5000, Philippines
West Visayas State University Medical Center
Iloilo City, 5000, Philippines
Makati Medical Center
Makati City, 1229, Philippines
Philippine General Hospital, Central Intensive Care Unit
Manila, 1000, Philippines
Quirino Memorial Medical Center
Quezon City, 1109, Philippines
St. Luke's Medical Center
Quezon City, 1112, Philippines
Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"
Bucharest, 021105, Romania
Spitalul Clinic de Boli Infectioase si tropicale "Dr. Victor Babes"
Bucharest, 030303, Romania
Spitalul Clinic de Boli Infectioase Cluj-Napoca
Cluj-Napoca, 400348, Romania
Spitalul Clinic de Boli Infectioase "Sf. Parascheva" Iasi
Iași, 700116, Romania
Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"
Timișoara, 300723, Romania
Private Healthcare Institution "Clinical Hospital 'Russian Railroad Medicine, Chelyabinsk'"
Chelyabinsk, 454048, Russia
State Budgetary Healthcare Institution "Regional Clinical Hospital No. 2" of the Ministry of Health
Krasnodar, 350012, Russia
GBUZ of Novosibirsk region "City Clinical Hospital # 2"
Novosibirsk, 630051, Russia
State autonomous institution of healthcare of the Perm Region" City clinical hospital #4"
Perm, 614107, Russia
FGBOU VO "The First St. Petersburg state medical university n. a. I.P. Pavlova"
Saint Petersburg, 197022, Russia
OGBUZ "Smolensk Regional Clinical Hospital"
Smolensk, 214018, Russia
FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF
Smolensk, 214019, Russia
Scientific Research Institute of Antimicrobial Chemotherapy
Smolensk, 214019, Russia
Gachon University Gil Medical Center - Infectious Disease
Incheon, Incheon Gwang'yeogsiv, 21565, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, 07441, South Korea
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916, Spain
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, 08221, Spain
Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro
Vigo, Pontevedra, 36312, Spain
Parc de Salut Mar- Hospital del Mar
Barcelona, 08003, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034, Spain
Hospital Regional Universitario de Malaga
Málaga, 29010, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Universitario Virgen del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic la Fe
Valencia, 46026, Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009, Spain
National Taiwan University Hospital Yun-Lin Branch
Douliu, Yunlin, 64041, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, 81362, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Taipei Municipal Wanfang Hospital
Taipei, 116, Taiwan
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
Srinagarind Hospital, Division of Infectious Disease and Tropical Medicine
Muang, Changwat Khon Kaen, 40002, Thailand
Bamrasnaradura Infectious Disease Institute (BIDI)
Muang, Changwat Nonthaburi, 11000, Thailand
Songklanagarind Hospital, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110, Thailand
Hacettepe Universitesi Tip Fakultesi
Ankara, 06100, Turkey (Türkiye)
Ankara University Faculty of Medicine
Ankara, 06230, Turkey (Türkiye)
T.C. Saglik Bakanligi Ankara Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Acibadem Atakent Hospital
Istanbul, 34303, Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34899, Turkey (Türkiye)
Ege University Faculty of Medicine
Izmir, 35040, Turkey (Türkiye)
Kocaeli University Medical Faculty
Kocaeli, 41380, Turkey (Türkiye)
Karadeniz Technical University Medical Faculty Farabi Hospital
Trabzon, 61080, Turkey (Türkiye)
OKU "Chernivetska oblasna klinichna likarnia", khirurhichne viddilennia
Chernivtsi, 58001, Ukraine
KZ "Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova", viddilennia khirurhii №2
Dnipro, 49005, Ukraine
Komunalnyi zaklad "Miska klinichna likarnia No.4" Dniprovskoi miskoi rady, viddilennia profpatolohii
Dnipro, 49102, Ukraine
Oblasna klinichna likarnia, viddilennia anesteziolohii ta intensyvnoi terapii
Ivano-Frankivsk, 76008, Ukraine
Ivano-Frankivska tsentralna miska klin likarnia, viddilennia khirurhii,
Ivano-Frankivsk, 76018, Ukraine
DU "Instytut zahalnoi ta nevidkladnoi khirurhii imeni V.T. Zaitseva Natsionalnoi akademii medychnykh
Kharkiv, 61103, Ukraine
Kyivska miska klinichna likarnia No. 3, khirurhichne viddilennia
Kyiv, 02125, Ukraine
Kyivska miska klinichna likarnia #4, khirurhichne viddilennia #1
Kyiv, 03110, Ukraine
Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia
Lviv, 79010, Ukraine
Odeska klinichna likarnia na zaliznychnomu transporti filii "Tsentr okhorony zdorovia" aktsionernoho
Odesa, 65059, Ukraine
Komunalne pidpryiemstvo "1-a miska klinichna likarnia Poltavskoi miskoi rady",
Poltava, 36039, Ukraine
Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova
Vinnytsia, 21018, Ukraine
Related Publications (4)
Raber SR, Xie R, Rogers H, Soto E, Arhin FF, Stone GG, Leister-Tebbe H, Chow JW. Microbiological, Clinical, and Pharmacokinetic/Pharmacodynamic Data to Support EUCAST Aztreonam-Avibactam Minimum Inhibitory Concentration Susceptibility Breakpoints Against Enterobacterales. Infect Dis Ther. 2026 Jan;15(1):183-195. doi: 10.1007/s40121-025-01267-3. Epub 2025 Nov 21.
PMID: 41269522DERIVEDXie R, Rogers H, Chow JW, Soto E, Raber SR. Population pharmacokinetic/pharmacodynamic modeling to optimize aztreonam-avibactam dose regimens for adult patients. Antimicrob Agents Chemother. 2025 Aug 6;69(8):e0195024. doi: 10.1128/aac.01950-24. Epub 2025 Jun 18.
PMID: 40530972DERIVEDCarmeli Y, Cisneros JM, Paul M, Daikos GL, Wang M, Torre-Cisneros J, Singer G, Titov I, Gumenchuk I, Zhao Y, Jimenez-Rodriguez RM, Liang L, Chen G, Pyptiuk O, Aksoy F, Rogers H, Wible M, Arhin FF, Luckey A, Leaney JL, Pypstra R, Chow JW; COMBACTE-CARE consortium REVISIT study group. Aztreonam-avibactam versus meropenem for the treatment of serious infections caused by Gram-negative bacteria (REVISIT): a descriptive, multinational, open-label, phase 3, randomised trial. Lancet Infect Dis. 2025 Feb;25(2):218-230. doi: 10.1016/S1473-3099(24)00499-7. Epub 2024 Oct 7.
PMID: 39389071DERIVEDDas S, Riccobene T, Carrothers TJ, Wright JG, MacPherson M, Cristinacce A, McFadyen L, Xie R, Luckey A, Raber S. Dose selection for aztreonam-avibactam, including adjustments for renal impairment, for Phase IIa and Phase III evaluation. Eur J Clin Pharmacol. 2024 Apr;80(4):529-543. doi: 10.1007/s00228-023-03609-x. Epub 2024 Jan 22.
PMID: 38252170DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- An independent adjudication committee (central blinded assessor) will be convened at regular intervals during the study. The adjudication committee will be blinded to study treatment and will review the clinical response assessments at each visit. In case of a discrepancy with the Investigator's assignment of clinical response, the adjudication committee's assessment will prevail. In addition, for cIAI subjects classified as a clinical failure, and all cIAI subjects classified as a cure who undergo another procedure (eg, another surgical procedure) subsequent to randomization, the expert panel will review the adequacy of the surgical source control.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2017
First Posted
November 1, 2017
Study Start
April 5, 2018
Primary Completion
February 23, 2023
Study Completion
February 23, 2023
Last Updated
December 10, 2024
Results First Posted
May 7, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.