None listed
Conditions
Interventions
randomized subjects in a 2:1 ratio to receive 1 of the 2 IV dosing regimens of either the ATM-AVI±MTZ treatment arm or the MER±COL treatment arm. Type of group
The investigational products are test product Aztreonam-Avibactam (ATM-AVI), co-administered drug Metronidazole (MTZ), and comparators Meropenem (MER) and Colistin (COL). randomize subjects in a 2:1 ratio to receive 1 of the 2 IV dosing regimens of either the ATM-AVI±MTZ treatment arm or the MER±COL treatment arm. The duration of treatment with IV study treatment is 5 to 14 days for cIAI and 7 to 14 days for HAP/VAP. The precise duration of treatment will be determined by the Investigator based
Sponsors
Pfizer Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subject must be ≥18 years of age. 2. Evidence of a personally signed and dated informed consent document 3. Subjects must have a confirmed diagnosis of HAP/VAP, or presumed diagnosis of cIAI requiring administration of IV antibacterial treatmen 4. Female subject of childbearing potential must have a negative serum or urine pregnancy test, with sensitivity of at least 25 mIU/mL 5. Subject must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Please see the protocol to see the information detailed.
Exclusion criteria
Exclusion criteria: 1.Subject has an APACHE II score >30 2.At Screening the subject is found to have/or strongly suspected to have an infection caused by a Gram-negative species not expected to respond to either ATM-AVI and/or MER (eg, Acinetobacter baumannii), or an infection caused by only Gram-positive species. 3.Subject has received more than one day (>24 hours) of any systemic antibiotic within the 48 hours prior to randomization. 4.Subject has a history of serious allergy such as anaphylaxis, angioedema and bronchospasm, hypersensitivity or any serious reactions to any systemic antibacterial which is allowed per protocol 5.Subject is unlikely to respond to up to 14 days of study treatment. Please see the protocol to see the information detailed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Intent To Treat and Clinically Evaluable analysis sets Measure:Proportion of subjects with clinical cure at Test of Cure visit in the Intent-To-Treat Timepoints:During the Test of Cure visit Proportion of subjects with clinical cure at Test of Cure visit in the Intent-To-Treat and Clinically Evaluable analysis sets (Note: For non-United States countries, the Intent To Treat and Clinically Evaluable are considered co-primary analysis sets. For the US, the Intent To Treat is considered the primary analysis set, while Clinically Evaluable is secondary) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:the microbiological Intent To Treat and microbiologically Evaluable analysis sets. Measure:Proportion of subjects with clinical cure at the Test of Cure visit in the microbiological Intent To Treat and microbiologically Evaluable analysis sets. Proportion of subjects with a favorable per subject microbiological response at the Test of Cure visit in the microbiological Intent To Treat and microbiologically evaluable analysis sets. Timepoints:The time will vary with regards to the kind of secondary endpoints. Some of them could be obtained during the Test of Cure visit, others subjects who died on or before 28 days from randomization in the Intent To Treat and microbiological Intent To Treat analysis sets” For more details please see the protocol | — |
Countries
Argentina, Brazil, Bulgaria, Chile, China, Croatia, Czech Republic, Greece, Hungary, India, Israel, Italy, Korea South, Macedonia, Malasya, Mexico, Peru, Philippines, Poland, Russian Federation, South Africa, Spain, Taiwan, Turkey, Ukraine, United States, Vietnam
Contacts
Public ContactMaria del Pilar Cherre
PFIZER S.A.
Outcome results
None listed