REVISIT

Not Applicable

• Conditions: -A048 Other specified bacterial intestinal infections-J168 Pneumonia due to other specified infectious organisms; Other specified bacterial intestinal infections; Pneumonia due to other specified infectious organisms; A048; J168

• Registration Number: PER-014-18
• Lead Sponsor: Pfizer Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-02
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Intent To Treat and Clinically Evaluable analysis sets<br>Measure:Proportion of subjects with clinical cure at Test of Cure visit in the Intent-To-Treat<br>Timepoints:During the Test of Cure visit<br>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)<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:the microbiological Intent To Treat and microbiologically Evaluable analysis sets.<br>Measure:Proportion of subjects with clinical cure at the Test of Cure visit in the microbiological Intent To Treat and microbiologically Evaluable analysis sets.<br>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.<br>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”<br><br>For more details please see the protocol<br>