REVISIT: 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.

• Sponsor: Pfizer (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT03329092
• Collaborator: Innovative Medicines Initiative (IMI) COMBACTE-CARE (EU) (Other), Biomedical Advanced Research and Development Authority (U.S. Fed)
• Enrollment: 375
• Locations: 157
• Arms: 2
• Anticipated Duration (Months): 56.4
• Patients Per Site: 2.4
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Complicated Intra-abdominal Infection; Hosptial Acquired Pneumonia; Ventilator Associated Pneumonia	Drug: ATM-AVI; Drug: MTZ; Drug: MER; Drug: COL	Phase 3

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 375 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Prospective, Randomized, Multicenter, Open Label, Central Assessor Blinded, Parallel Group, Comparative StudyProspective, Randomized, Multicenter, Open Label, Central Assessor Blinded, Parallel Group, Comparative Study
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 5, 2018
• Anticipated Primary Completion Date: Dec 16, 2022
• Anticipated Study Completion Date: Dec 16, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aztreonam-Avibactam ± Metronidazole All patients randomised to this arm will receive ATM-AVI; all patients with cIAI will receive MTZ for anaerobic cover	Drug: 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; Drug: MTZ; For cIAI only; 500 mg/100 mL metronidazole iv infusion over 1hr q8h
Active Comparator: 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	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; 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

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects with clinical cure in the ITT and CE analysis sets [Test of Cure (TOC) visit, Day 28 +/- 3 days]

   Proportion of subjects meeting the criteria for clinical cure

Secondary Outcome Measures

1. Proportion of subjects with clinical cure in the m-ITT and ME analysis sets [Test of Cure (TOC) visit, Day 28 (+/- 3 days)]

   Proportion of subjects meeting the criteria for clinical cure

2. Proportion of subjects with clinical cure by infection type in the ITT and CE analysis sets. [Test of Cure (TOC) visit, Day 28 (+/- 3 days)]

   Proportion of subjects meeting the criteria for clinical cure

3. Proportion of subjects with clinical cure for subjects with MBL positive pathogens in the micro ITT and ME analysis sets. [Test of Cure (TOC) visit, Day 28 (+/- 3 days)]

   Proportion of subjects meeting the criteria for clinical cure

4. Proportion of subjects with a favorable per subject microbiological response in the micro ITT and ME analysis sets. [Test of Cure (TOC) visit, Day 28 (+/- 3 days)]

   Proportion of subjects with a favourable microbiological response (aggregate of eradication + presumed eradication)

5. Proportion of subjects who died [Day 28]

   Daily mortality assessment

6. PK of ATM [Days 1 and 4]

   Plasma concentration of ATM

7. PK/PD relationship between exposure and clinical response for ATM AVI±MTZ in the popPK analysis set [Test of Cure (TOC) visit, Day 28 (+/- 3 days)]

   Correlation between plasma concentration of ATM and clinical cure

8. PK of AVI [Days 1 and 4]

   Plasma concentration of AVI

9. PK/PD relationship between exposure and clinical response for ATM/AVI +/- MTZ in the popPK analysis set [Test of Cure (TOC) days 28 (+/- 3 days)]

   Correlation between concentration of AVI and clinical cure

10. PK/PD relationship between exposure and microbiological response for ATM/AVI+/-MTZ in the popPK analysis set [Test of Cure (TOC) visit, Days 28 (+/- 3 days)]

    Correlation between plasma concentration of ATM and microbiological response

11. PK/PD relationship between exposure and microbiological response for ATM/AVI+/-MTZ in the popPK analysis set [Test of Cure (TOC) visit, day 28 (+/- 3 days)]

    Correlation between plasma concentration of AVI and microbiological response

12. Description of safety in terms of adverse events [Throughout study to Late Follow Up visit (Day 45 +/- 3 days)]

    Descriptive summary of adverse events

Other Outcome Measures

1. Proportion of subjects with clinical cure in the ITT, micro ITT, CE and ME analysis sets [End of Treatment (EOT) visit (variable, between Days 1 and 15)]

   Proportion of subjects meeting the criteria for clinical cure

2. Proportion of subjects with clinical cure by infection type in the ITT and CE analysis sets [End of Treatment (EOT) visit (variable, between Days 1 and 15)]

   Proportion of subjects meeting the criteria for clinical cure

3. Proportion of subjects with a favorable per subject microbiological response in the the micro ITT and ME analysis sets [End of Treatment (EOT) visit (variable, between Days 1 and 15)]

   Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)

4. Proportion of subjects with a favorable per pathogen microbiological response in the micro ITT and ME analysis sets [End of Treatment (EOT), (variable between Days 1 and 15)]

   Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)

5. Proportion of subjects with a favorable per subject microbiological response by pathogen resistance type (eg, ATM resistant, ESBL positive, carbapenamase positive, MBL positive) in the micro ITT and ME analysis sets [End of Treatment (EOT), (variable, between Days 1 and 15)]

   Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)

6. Proportion of subjects with a favorable per pathogen microbiological response by pathogen resistance type in the micro ITT and ME analysis sets [End of Treatment (EOT) visits, (variable between Days 1 and 15)]

   Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)

7. Proportion of subjects with clinical cure using objective clinical measures [Test of Cure (TOC) visit, Day 28 +/- 3 days)]

   Proportion of subjects with clinical cure

8. Proportion of subjects who died [Day 14]

   Daily mortality assessment

9. Health resource utilization in terms of length of hospital stay [Test of Cure (TOC), Day 28 +/- 3 days]

   Length of hospital stay (days), including any readmissions

10. Relationship between (as yet undetermined) biomarkers and liver transaminase elevations in response to exposure to ATM-AVI [Day 1 and 4]

    Correlation between (yet to be determined) plasma biomarkers and elevated liver transaminases

11. Proportion of subjects with a favorable per pathogen microbiological response in the micro ITT and ME analysis sets [Test of Cure (TOC) visit (Day 28 +/- 3 days)]

    Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)

12. Proportion of subjects with a favorable per subject microbiological response by pathogen resistance type (eg, ATM resistant, ESBL positive, carbapenamase positive, MBL positive) in the micro ITT and ME analysis sets [Test of Cure (TOC) visits, Day 28 +/- 3 days]

    Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)

13. Proportion of subjects with a favorable per pathogen microbiological response by pathogen resistance type in the micro ITT and ME analysis sets [Test of Cure (TOC) visits, Day 28 +/- 3 days]

    Proportion of subjects with a favourable microbiological response (aggregate of eradication and presumed eradication)

14. Health resource utilization in terms of treatment duration [Test of Cure (TOC), Day 28 +/- 3 days]

    Length of study treatment (days)

15. Health resource utilization in terms of length of ICU stay [Test of Cure (TOC), Day 28 +/- 3 days]

    Length of intensive care unit (ICU) stay (days)

16. Health resource utilization in terms of transfer to ICU [Test of Cure (TOC), Day 28 +/- 3 days]

    Transfer to the ICU (Yes/No)

17. Health resource utilization in terms of use of mechanical ventilation [Test of Cure (TOC), Day 28 +/- 3 days]

    Mechanical ventilation (Yes/No) for HAP/VAP subjects

18. Health resource utilization in terms of duration of mechanical ventilation [Test of Cure (TOC), Day 28 +/- 3 days]

    Length of mechanical ventilation (days) for HAP/VAP subjects

19. Health resource utilization in terms of subsequent unplanned surgical intervention [Test of Cure (TOC), Day 28 +/- 3 days]

    Subsequent unplanned surgical intervention (YES/NO) for cIAI subjects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banner University Medical Center - Tucson	Tucson	Arizona	United States	85719
2	Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Torrance	California	United States	90502
3	Harbor-UCLA Medical Center	Torrance	California	United States	90509
4	Southern Illinois University School of Medicine	Springfield	Illinois	United States	62702
5	Memorial Medical Center	Springfield	Illinois	United States	62781
6	Sanatorio Britanico	Rosario	Santa FE	Argentina	2000
7	Sanatorio Servicios Medicos SM	Santo Tome	Santa FE	Argentina	S3016
8	Hospital San Roque	Córdoba		Argentina	5000
9	University Hospital Alexandrovska, Clinic of Anesthesiology and Intensive Care	Sofia		Bulgaria	1431
10	University Hospital Queen Joanna ISUL, Clinic of Surgery	Sofia		Bulgaria	1527
11	University Multiprofile Hospital for Active Treatment ''Prof.Dr Stoyan Kirkovich''AD	Stara Zagora		Bulgaria	6003
12	Peking University Third Hospital	Beijing	Beijing	China	100191
13	Zhangzhou Municipal Hospital of Fujian Province	Zhangzhou	Fujian	China	363000
14	ZhuJiang Hospital of Southern Medical University	Guangzhou	Guangdong	China	510280
15	The First Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong	China	515041
16	The Second People's Hospital of Shenzhen	Shenzhen	Guangdong	China	518035
17	Nanning First People's Hospital	Nanning	Guangxi Zhuang Autonomous Region	China	530022
18	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi	China	541001
19	Changsha Third Hospital	Changsha	Hunan	China	410000
20	Hunan Province People's Hospital	Changsha	Hunan	China	410005
21	Baotou Central Hospital	Baotou	Inner Mongolia Autonomous Region	China	014000
22	Jiangyin People's Hospital	Jiangyin	Jiangsu	China	214400
23	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu	China	212001
24	Huashan Hospital Fudan University	Shanghai	Shanghai	China	200040
25	Shanghai Pulmonary Hospital	Shanghai	Shanghai	China	200433
26	The First people's Hospital of Kunming	Kunming	Yunnan	China	650034
27	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003
28	Taizhou Hospital of Zhejiang Province	Linhai	Zhejiang	China	317000
29	Lishui People's Hospital	Lishui	Zhejiang	China	323000
30	Quzhou People's Hospital	Quzhou	Zhejiang	China	324000
31	Peking University People's Hospital	Beijing		China	100044
32	Tianjin Union Medical Center	Tianjin		China	300000
33	Klinicka bolnica Merkur	Zagreb	GRAD Zagreb	Croatia	10000
34	Klinicki bolnicki centar Rijeka	Rijeka	Primorsko-goranska Zupanija	Croatia	51000
35	University Hospital Centre Osijek	Osijek		Croatia	31000
36	General Hospital "Dr. Josip Bencevic" Slavonski Brod	Slavonski Brod		Croatia	35000
37	Clinical Hospital Dubrava	Zagreb		Croatia	10000
38	University Hospital Centre Zagreb	Zagreb		Croatia	10000
39	Fakultni nemocnice Brno	Brno		Czechia	625 00
40	Krajska zdravotni, a.s. - Nemocnice Decin, o.z.	Decin		Czechia	40599
41	Lekarna Nemocnice Decin, Krajska zdravotni, a.s.- Nemocnice Decin, o.z.	Decin		Czechia	40599
42	Public Hospital Kolin, a.s.	Kolin III		Czechia	280 02
43	Nemocnice Kyjov, prispevkova organizace	Kyjov		Czechia	697 01
44	Fakultni nemocnice Kralovske Vinohrady	Praha 10		Czechia	100 34
45	General Hospital of Athens "Evangelismos"	Athens		Greece	10676
46	General and Chest Diseases Hospital "Sotiria"	Athens		Greece	11527
47	General Hospital of Athens "Laiko"	Athens		Greece	11527
48	University General Hospital "ATTIKON"	Athens		Greece	12462
49	University General Hospital of Heraklion	Heraklion, Crete		Greece	71110
50	University General Hospital of Larissa	Larissa		Greece	41110
51	Koutlimbaneio and Triantafylleio General Hospital of Larissa	Larissa		Greece	41221
52	King George Hospital	Visakhapatnam	Andhra Pradesh	India	530002
53	Artemis hospital	Gurugram	Haryana	India	122001
54	Victoria Hospital, Bangalore Medical College and Research Institute	Bangalore	Karnataka	India	560002
55	M S Ramaiah Medical College and Hospitals	Bangalore	Karnataka	India	560054
56	Kasturba Medical College and Hospital	Manipal	Karnataka	India	576104
57	JSS Hospital	Mysuru	Karnataka	India	570004
58	Amrita Institute of Medical Sciences & Research Centre	Kochi	Kerala	India	682041
59	Government Medical College, Kozhikode	Kozhikode	Kerala	India	673008
60	Deenanath Mangeshkar Hospital And Research Centre	Pune	Maharashtra	India	411004
61	S.R. Kalla Memorial Gastro & General Hospital	Jaipur	Rajasthan	India	302001
62	Apollo Hospitals	Chennai	Tamil NADU	India	600006
63	King George's Medical University	Lucknow	Uttar Pradesh	India	226003
64	Dayanand Medical College and Hospital	Ludhiana		India	141001
65	Sahyadri Specialty Hospital	Pune		India
66	Ha'Emek Medical Center	Afula		Israel	1834111
67	Assuta Ashdod University Hospital	Ashdod		Israel	7747629
68	Rambam Health Care Campus	Haifa		Israel	3109601
69	Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem	Jerusalem		Israel	9112001
70	Rabin Medical Center, Beilinson Hospital	Petah Tikva		Israel	4941492
71	Tel Aviv Sourasky Medical Center	Tel Aviv		Israel	6423906
72	The Chaim Sheba Medical Center	Tel-Hashomer		Israel	5265601
73	Shamir Medical Center, Infectious Diseases Unit	Zerifin		Israel	7030000
74	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milano	Milan	Italy	20122
75	Azienda Ospedaliero-Universitaria Ospedali Riuniti	Foggia		Italy	71122
76	Azienda Ospedaliero Universitaria di Modena	Modena		Italy	41124
77	Farmacia Ospedaliera - Direzione Assistenza Farmaceutica	Modena		Italy	41124
78	SC di Radiologia - Azienda Ospedaliera Universitaria di Modena	Modena		Italy	41124
79	Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello	Pisa		Italy	56100
80	UO Radiognastostica 2 Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello	Pisa		Italy	56100
81	UO Farmaceutica Azienda Ospedaliero-Universitaria Pisana	Pisa		Italy	56126
82	Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa	Udine		Italy	33100
83	Gachon University Gil Medical Center - Infectious Disease	Incheon	Incheon Gwang'yeogsiv	Korea, Republic of	21565
84	Dong-A University Hospital	Busan		Korea, Republic of	49201
85	Seoul National University Hospital	Seoul		Korea, Republic of	03080
86	The Catholic University of Korea, Eunpyeong St. Mary's Hospital	Seoul		Korea, Republic of	03312
87	Hallym University Kangnam Sacred Heart Hospital	Seoul		Korea, Republic of	07441
88	Hospital Seberang Jaya	Seberang Jaya	Pulau Pinang	Malaysia	13700
89	Hospital Sultanah Nur Zahirah	Kuala Terengganu	Terengganu	Malaysia	20400
90	University Malaya Medical Centre	Kuala Lumpur		Malaysia	59100
91	Hospital Civil Fray Antonio Alcalde	Guadalajara	Jalisco	Mexico	44280
92	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo LEON	Mexico	64460
93	Hospital General 450	Durango		Mexico	34217
94	De La Salle Medical and Health Sciences Institute	City Of Dasmarinas	Cavite	Philippines	4114
95	Baguio General Hospital and Medical Center	Baguio City		Philippines	2600
96	Davao Doctors Hospital	Davao City		Philippines	8000
97	St. Paul's Hospital of Iloilo, Inc.	Iloilo City		Philippines	5000
98	West Visayas State University Medical Center	Iloilo City		Philippines	5000
99	Makati Medical Center	Makati City		Philippines	1229
100	Philippine General Hospital, Central Intensive Care Unit	Manila		Philippines	1000
101	Asian Hospital and Medical Center	Muntinlupa City		Philippines	1780
102	Quirino Memorial Medical Center	Quezon City		Philippines	1109
103	St. Luke's Medical Center	Quezon City		Philippines	1112
104	Institutul National de Boli Infectioase "Prof. Dr. Matei Bals"	Bucuresti		Romania	021105
105	Spitalul Clinic de Boli Infectioase si tropicale "Dr. Victor Babes"	Bucuresti		Romania	030303
106	Spitalul Clinic de Boli Infectioase Cluj-Napoca	Cluj-Napoca		Romania	400348
107	Spitalul Clinic de Boli Infectioase "Sf. Parascheva" Iasi	Iasi		Romania	700116
108	Spitalul Clinic Judetean de Urgenta "Pius Brinzeu"	Timisoara		Romania	300723
109	Private Healthcare Institution "Clinical Hospital 'Russian Railroad Medicine, Chelyabinsk'"	Chelyabinsk		Russian Federation	454048
110	State Budgetary Healthcare Institution "Regional Clinical Hospital No. 2" of the Ministry of Health	Krasnodar		Russian Federation	350012
111	GBUZ of Novosibirsk region "City Clinical Hospital # 2"	Novosibirsk		Russian Federation	630051
112	State autonomous institution of healthcare of the Perm Region" City clinical hospital #4"	Perm		Russian Federation	614107
113	FGBOU VO "The First St. Petersburg state medical university n. a. I.P. Pavlova"	Saint-Petersburg		Russian Federation	197022
114	OGBUZ "Smolensk Regional Clinical Hospital"	Smolensk		Russian Federation	214018
115	FSBEI of HE "Smolensk State Medical University" of the Ministry of Health of the RF	Smolensk		Russian Federation	214019
116	Scientific Research Institute of Antimicrobial Chemotherapy	Smolensk		Russian Federation	214019
117	Hospital Universitari Germans Trias i Pujol	Badalona	Barcelona	Spain	08916
118	Hospital Universitario Mutua de Terrassa	Terrassa	Barcelona	Spain	08221
119	Complejo Hospitalario Universitario de Vigo. Area Sanitaria de Vigo. Hospital Alvaro Cunqueiro	Vigo	Pontevedra	Spain	36312
120	Parc de Salut Mar- Hospital del Mar	Barcelona		Spain	08003
121	Hospital de la Santa Creu i Sant Pau	Barcelona		Spain	08041
122	Hospital Universitario Reina Sofia	Cordoba		Spain	14004
123	Hospital Universitario Ramon y Cajal	Madrid		Spain	28034
124	Hospital Regional Universitario de Malaga	Malaga		Spain	29010
125	Hospital Universitario Virgen Macarena	Sevilla		Spain	41009
126	Hospital Universitario Virgen del Rocio	Sevilla		Spain	41013
127	Hospital Universitari i Politecnic la Fe	Valencia		Spain	46026
128	Hospital Universitario Miguel Servet	Zaragoza		Spain	50009
129	National Taiwan University Hospital Yun-Lin Branch	Douliou	Yunlin	Taiwan	64041
130	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City		Taiwan	807
131	Kaohsiung Veterans General Hospital	Kaohsiung		Taiwan	81362
132	Taichung Veterans General Hospital	Taichung City		Taiwan	40705
133	National Taiwan University Hospital	Taipei City		Taiwan	10002
134	Taipei Municipal Wanfang Hospital	Taipei		Taiwan	116
135	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok	Thailand	10700
136	Srinagarind Hospital, Division of Infectious Disease and Tropical Medicine	Muang	Khon Kaen	Thailand	40002
137	Bamrasnaradura Infectious Disease Institute (BIDI)	Muang	Nonthaburi	Thailand	11000
138	Songklanagarind Hospital, Prince of Songkla University	Hat Yai	Songkhla	Thailand	90110
139	Hacettepe Universitesi Tip Fakultesi	Ankara		Turkey	06100
140	T.C. Saglik Bakanligi Ankara Sehir Hastanesi	Ankara		Turkey	06800
141	Acibadem Atakent Hospital	Istanbul		Turkey	34303
142	Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi	Istanbul		Turkey	34899
143	Ege University Faculty of Medicine	Izmir		Turkey	35040
144	Kocaeli University Medical Faculty	Kocaeli		Turkey	41380
145	Karadeniz Technical University Medical Faculty Farabi Hospital	Trabzon		Turkey	61080
146	OKU "Chernivetska oblasna klinichna likarnia", khirurhichne viddilennia	Chernivtsi		Ukraine	58001
147	KZ "Dnipropetrovska oblasna klinichna likarnia im. I.I. Mechnykova", viddilennia khirurhii №2	Dnipro		Ukraine	49005
148	Komunalnyi zaklad "Miska klinichna likarnia No.4" Dniprovskoi miskoi rady, viddilennia profpatolohii	Dnipro		Ukraine	49102
149	Oblasna klinichna likarnia, viddilennia anesteziolohii ta intensyvnoi terapii	Ivano-Frankivsk		Ukraine	76008
150	Ivano-Frankivska tsentralna miska klin likarnia, viddilennia khirurhii,	Ivano-Frankivsk		Ukraine	76018
151	DU "Instytut zahalnoi ta nevidkladnoi khirurhii imeni V.T. Zaitseva Natsionalnoi akademii medychnykh	Kharkiv		Ukraine	61103
152	Kyivska miska klinichna likarnia No. 3, khirurhichne viddilennia	Kyiv		Ukraine	02125
153	Kyivska miska klinichna likarnia #4, khirurhichne viddilennia #1	Kyiv		Ukraine	03110
154	Komunalne nekomertsiine pidpryiemstvo Lvivskoi oblasnoi rady Lvivska oblasna klinichna likarnia	Lviv		Ukraine	79010
155	Odeska klinichna likarnia na zaliznychnomu transporti filii "Tsentr okhorony zdorovia" aktsionernoho	Odesa		Ukraine	65059
156	Komunalne pidpryiemstvo "1-a miska klinichna likarnia Poltavskoi miskoi rady",	Poltava		Ukraine	36039
157	Vinnytska oblasna klinichna likarnia im. M.I. Pyrohova	Vinnytsia		Ukraine	21018

Sponsors and Collaborators

• Pfizer
• Innovative Medicines Initiative (IMI) COMBACTE-CARE (EU)
• Biomedical Advanced Research and Development Authority

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT03329092
• Other Study ID Numbers: C3601002; D4910C00004; 2017-002742-68
• First Posted: Nov 1, 2017
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Pfizer: Complicated intra-abdominal infection; Hosptial acquired pneumonia; Ventilator associated pneumonia; Gram negative infections; Metallo-beta lactamase; Multi drug resistant pathogens
• Additional relevant MeSH terms: Infections; Communicable Diseases; Pneumonia; Pneumonia, Ventilator-Associated; Intraabdominal Infections

Study Results

No Results Posted as of Aug 19, 2022