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.

NCT ID: NCT03329092

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 422 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2023-02-23

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.

Detailed 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 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

Conditions

Complicated Intra-abdominal Infection; Hosptial Acquired Pneumonia; Ventilator Associated Pneumonia

Keywords

Complicated intra-abdominal infection; Hosptial acquired pneumonia; Ventilator associated pneumonia; Gram negative infections; Metallo-beta lactamase; Multi drug resistant pathogens

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aztreonam-Avibactam ± Metronidazole

All patients randomised to this arm will receive ATM-AVI; all patients with cIAI will receive MTZ for anaerobic cover

Group Type: EXPERIMENTAL

ATM-AVI

Intervention Type: 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

Intervention Type: DRUG

For cIAI only; 500 mg/100 mL metronidazole iv infusion over 1hr q8h

Meropenem ± Colistin

All patients randomised to this arm will receive MER; addition of COL will be at investigator's discretion in line with local practice

Group Type: ACTIVE_COMPARATOR

MER

Intervention Type: 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

Intervention Type: 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

Interventions

ATM-AVI

(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

Intervention Type: DRUG

MTZ

For cIAI only; 500 mg/100 mL metronidazole iv infusion over 1hr q8h

Intervention Type: DRUG

MER

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

Intervention Type: DRUG

COL

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

Intervention Type: DRUG

Eligibility Criteria

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 stated in the protocol are met and negative pregnancy test

Additional for cIAI:

1. 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

2. Surgical intervention within 24 hours (before or after) the administration of the first dose of study drug

Additional for HAP/VAP:

1. Onset symptoms > 48h after admission to or <7 days after discharge from an inpatient care facility

2. New or worsening infiltrate on CXR or CT scan

3. Clinical signs and symptoms and laboratory findings consistent with HAP/VAP

4. Respiratory specimen obtained for Gram stain and culture following onset of symptoms and prior to randomisation

Exclusion Criteria

All subjects:

1. APACHE II score > 30

2. Confirmed or suspected infection caused by Gram-negative species not expected to respond to study drug, or Gram-positive species

3. Receipt of >24 hr systemic antibiotic within 48h prior to randomisation (exception in case of treatment failure)

4. 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

5. Known Clostridium difficle associated diarrhoea

6. Requirement for effective concomitant systemic antibacterials or antifungals

7. Creatinine clearance ≤15 ml/min or requirement or expectation for renal replacement therapy

8. Acute hepatitis, cirrhosis, acute hepatic failure, chronic hepatic failure

9. 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

10. Patient has a total bilirubin >2 × ULN, unless isolated hyperbilirubinemia is directly related to infectious process or due to known Gilbert's disease

11. 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

12. Absolute neutrophil count <500/mm3

13. Pregnant or breastfeeding or if of child bearing potential, not using a medically accepted effective method of birth control.

14. Any other condition that may confound the results of the study or pose additional risks to the subject

15. Unlikely to comply with protocol

16. History of epilepsy or seizure disorders excluding febrile seizures of childhood

Additional for cIAI

1. 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

2. Simple cholecystitis, gangrenous cholecystitis without rupture, simple appendicitis, acute suppurative cholangitis, infected necrotizing pancreatitis, pancreatic abscess

3. Prior liver, pancreas or small-bowel transplant

4. Staged abdominal repair (STAR), open abdomen technique or marsupialisation

Additional for HAP/VAP

1. APACHE II score < 10

2. Known or high likelihood of Gram-positive monomicrobial infection

3. Lung abscess, pleural empyema, post-obstructive pneumonia

4. Lung or heart transplant

5. Myasthenia gravis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovative Medicines Initiative

OTHER

Sponsor Role: collaborator

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Banner University Medical Center - Tucson

Tucson, Arizona, United States

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

The First people's Hospital of Kunming

Kunming, Yunnan, China

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, China

Lishui People's Hospital

Lishui, Zhejiang, China

Quzhou People's Hospital

Quzhou, Zhejiang, China

Peking University People's Hospital

Beijing, , China

Jiangyin People's Hospital

Jiangyin, , China

Tianjin Union Medical Center

Tianjin, , China

Klinicka bolnica Merkur

Zagreb, City of Zagreb, Croatia

Klinicki bolnicki centar Rijeka

Rijeka, Primorje-Gorski Kotar County, Croatia

University Hospital Centre Osijek

Osijek, , Croatia

General Hospital "Dr. Josip Bencevic" Slavonski Brod

Slavonski Brod, , Croatia

Clinical Hospital Dubrava

Zagreb, , Croatia

Fakultni nemocnice Brno

Brno, , Czechia

Krajska zdravotni, a.s. - Nemocnice Decin, o.z.

Děčín, , Czechia

Lekarna Nemocnice Decin, Krajska zdravotni, a.s.- Nemocnice Decin, o.z.

Děčín, , Czechia

Public Hospital Kolin, a.s.

Kolin III, , Czechia

Nemocnice Kyjov, prispevkova organizace

Kyjov, , Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, , Czechia

General Hospital of Athens "Evangelismos"

Athens, , Greece

General and Chest Diseases Hospital "Sotiria"

Athens, , Greece

General Hospital of Athens "Laiko"

Athens, , Greece

University General Hospital "ATTIKON"

Athens, , Greece

University General Hospital of Heraklion

Heraklion, Crete, , Greece

University General Hospital of Larissa

Larissa, , Greece

Koutlimbaneio and Triantafylleio General Hospital of Larissa

Larissa, , Greece

King George Hospital

Visakhapatnam, Andhra Pradesh, India

Victoria Hospital, Bangalore Medical College and Research Institute

Bangalore, Karnataka, India

M S Ramaiah Medical College and Hospitals

Bangalore, Karnataka, India

Kasturba Medical College and Hospital

Manipal, Karnataka, India

JSS Hospital

Mysuru, Karnataka, India

Amrita Institute of Medical Sciences & Research Centre

Kochi, Kerala, India

Government Medical College, Kozhikode

Kozhikode, Kerala, India

Deenanath Mangeshkar Hospital And Research Centre

Pune, Maharashtra, India

Sahyadri Super Speciality Hospital

Pune, Maharashtra, India

Sahyadri Super Specialty Hospital

Pune, Maharashtra, India

S.R. Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, India

Apollo Hospitals

Chennai, Tamil Nadu, India

King George's Medical University

Lucknow, Uttar Pradesh, India

Dayanand Medical College and Hospital

Ludhiana, , India

Sahyadri Clinical Research & Development Center

Pune, , India

Sahyadri Specialty Hospital

Pune, , India

Assuta Ashdod University Hospital

Ashdod, , Israel

Rambam Health Care Campus

Haifa, , Israel

Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

Jerusalem, , Israel

Rabin Medical Center, Beilinson Hospital

Petah Tikva, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

The Chaim Sheba Medical Center

Tel Litwinsky, , Israel

Shamir Medical Center, Infectious Diseases Unit

Ẕerifin, , Israel

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, Milan, Italy

Azienda Ospedaliero-Universitaria Ospedali Riuniti

Foggia, , Italy

Azienda Ospedaliero Universitaria di Modena

Modena, , Italy

Farmacia Ospedaliera - Direzione Assistenza Farmaceutica

Modena, , Italy

SC di Radiologia - Azienda Ospedaliera Universitaria di Modena

Modena, , Italy

Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello

Pisa, , Italy

UO Radiognastostica 2 Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello

Pisa, , Italy

UO Farmaceutica Azienda Ospedaliero-Universitaria Pisana

Pisa, , Italy

Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa

Udine, , Italy

Hospital Seberang Jaya

Seberang Jaya, Pulau Pinang, Malaysia

Hospital Sultanah Nur Zahirah

Kuala Terengganu, Terengganu, Malaysia

University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

Monterrey, Nuevo León, Mexico

De La Salle Medical and Health Sciences Institute

City of Dasmarinas, Cavite, Philippines

Baguio General Hospital and Medical Center

Baguio City, , Philippines

Asian Hospital and Medical Center

City of Muntinlupa, , Philippines

Davao Doctors Hospital

Davao City, , Philippines

St. Paul's Hospital of Iloilo, Inc.

Iloilo City, , Philippines

West Visayas State University Medical Center

Iloilo City, , Philippines

Makati Medical Center

Makati City, , Philippines

Philippine General Hospital, Central Intensive Care Unit

Manila, , Philippines

Quirino Memorial Medical Center

Quezon City, , Philippines

St. Luke's Medical Center

Quezon City, , Philippines

Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"

Bucharest, , Romania

Spitalul Clinic de Boli Infectioase si tropicale "Dr. Victor Babes"

Bucharest, , Romania

Spitalul Clinic de Boli Infectioase Cluj-Napoca

Cluj-Napoca, , Romania

Spitalul Clinic de Boli Infectioase "Sf. Parascheva" Iasi

Iași, , Romania

Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"

Timișoara, , Romania

Private Healthcare Institution "Clinical Hospital 'Russian Railroad Medicine, Chelyabinsk'"

Chelyabinsk, , Russia

State Budgetary Healthcare Institution "Regional Clinical Hospital No. 2" of the Ministry of Health

Krasnodar, , Russia

GBUZ of Novosibirsk region "City Clinical Hospital # 2"

Novosibirsk, , Russia

State autonomous institution of healthcare of the Perm Region" City clinical hospital #4"

Perm, , Russia

FGBOU VO "The First St. Petersburg state medical university n. a. I.P. Pavlova"

Saint Petersburg, , Russia

OGBUZ "Smolensk Regional Clinical Hospital"

Smolensk, , Russia

FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF

Smolensk, , Russia

Scientific Research Institute of Antimicrobial Chemotherapy

Smolensk, , Russia

Gachon University Gil Medical Center - Infectious Disease

Incheon, Incheon Gwang'yeogsiv, South Korea

Seoul National University Hospital

Seoul, , South Korea

The Catholic University of Korea, Eunpyeong St. Mary's Hospital

Seoul, , South Korea

Hallym University Kangnam Sacred Heart Hospital

Seoul, , South Korea

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Mutua de Terrassa

Terrassa, Barcelona, Spain

Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Parc de Salut Mar- Hospital del Mar

Barcelona, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Regional Universitario de Malaga

Málaga, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Universitario Virgen del Rocio

Seville, , Spain

Hospital Universitari i Politecnic la Fe

Valencia, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

National Taiwan University Hospital Yun-Lin Branch

Douliu, Yunlin, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Municipal Wanfang Hospital

Taipei, , Taiwan

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Srinagarind Hospital, Division of Infectious Disease and Tropical Medicine

Muang, Changwat Khon Kaen, Thailand

Bamrasnaradura Infectious Disease Institute (BIDI)

Muang, Changwat Nonthaburi, Thailand

Songklanagarind Hospital, Prince of Songkla University

Hat Yai, Changwat Songkhla, Thailand

Hacettepe Universitesi Tip Fakultesi

Ankara, , Turkey (Türkiye)

Ankara University Faculty of Medicine

Ankara, , Turkey (Türkiye)

T.C. Saglik Bakanligi Ankara Sehir Hastanesi

Ankara, , Turkey (Türkiye)

Acibadem Atakent Hospital

Istanbul, , Turkey (Türkiye)

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

Ege University Faculty of Medicine

Izmir, , Turkey (Türkiye)

Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Karadeniz Technical University Medical Faculty Farabi Hospital

Trabzon, , Turkey (Türkiye)

OKU "Chernivetska oblasna klinichna likarnia", khirurhichne viddilennia

Chernivtsi, , Ukraine

KZ "Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova", viddilennia khirurhii №2

Dnipro, , Ukraine

Komunalnyi zaklad "Miska klinichna likarnia No.4" Dniprovskoi miskoi rady, viddilennia profpatolohii

Dnipro, , Ukraine

Oblasna klinichna likarnia, viddilennia anesteziolohii ta intensyvnoi terapii

Ivano-Frankivsk, , Ukraine

Ivano-Frankivska tsentralna miska klin likarnia, viddilennia khirurhii,

Ivano-Frankivsk, , Ukraine

DU "Instytut zahalnoi ta nevidkladnoi khirurhii imeni V.T. Zaitseva Natsionalnoi akademii medychnykh

Kharkiv, , Ukraine

Kyivska miska klinichna likarnia No. 3, khirurhichne viddilennia

Kyiv, , Ukraine

Kyivska miska klinichna likarnia #4, khirurhichne viddilennia #1

Kyiv, , Ukraine

Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia

Lviv, , Ukraine

Odeska klinichna likarnia na zaliznychnomu transporti filii "Tsentr okhorony zdorovia" aktsionernoho

Odesa, , Ukraine

Komunalne pidpryiemstvo "1-a miska klinichna likarnia Poltavskoi miskoi rady",

Poltava, , Ukraine

Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova

Vinnytsia, , Ukraine

Countries

Chile; Hungary; Peru; South Africa; Vietnam; United States; Argentina; Bulgaria; China; Croatia; Czechia; Greece; India; Israel; Italy; Malaysia; Mexico; Philippines; Romania; Russia; South Korea; Spain; Taiwan; Thailand; Turkey (Türkiye); Ukraine

References

Xie 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.

Reference Type: DERIVED

PMID: 40530972 (View on PubMed)

Carmeli 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.

Reference Type: DERIVED

PMID: 39389071 (View on PubMed)

Das 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.

Reference Type: DERIVED

PMID: 38252170 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pmiform.com/clinical-trial-info-request?StudyID=C3601002

To obtain contact information for a study center near you, click here.

Other Identifiers

D4910C00004

Identifier Type: OTHER

Identifier Source: secondary_id

2017-002742-68

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C3601002

Identifier Type: -

Identifier Source: org_study_id