Ventilator-Associated Pneumonia/Hospital-Acquired Pneumon... | NCT00050401

Studies
Ventilator-Associated Pneumonia/Hospital-Acquired Pneumonia Requiring Mechanical Ventilatory Support

NCT00050401

Sponsor

Pfizer

Status

Completed

Last Update Posted

Sep 1, 2017Actual

Enrollment

500

Phase

Phase 3

Conditions

Pneumonia

Interventions

MERREM I.V. 2g as a 3 hour infusion every 8 hours
vancomycin I.V. 1 g every 12 hours
tobramycin I.V. 5 mg/kg every 24 hours
MERREM I.V. 1g as a 30 minute infusion every 8 hours
MERREM I.V. 500 mg as a 3 hour infusion every 8 hours

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2002

Primary Completion Date

Sep 2004Actual

Completion Date

Sep 2004Actual

First Submitted Date

Dec 8, 2002

First Submission Date that Met QC Criteria

Dec 9, 2002

First Posted Date

Dec 10, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2017

Last Update Posted Date

Sep 1, 2017Actual

Description Module

Brief Summary

The purpose of the study is to find out if high dose antibiotic (meropenem, MERREM® I.V.), along with another drug called an aminoglycoside (a different type of antibiotic) is effective in decreasing or reducing the rate of antibiotic resistant Pseudomonas aeruginosa, Acinetobacter (germs that can cause pneumonia), and the rate of resistance in other difficult to treat germs which may cause hospital-acquired pneumonia requiring mechanical ventilatory support. The study hopes to show that by increasing the amount of meropenem administered and increasing the duration of infusion (release of the drug into the bloodstream), levels of the drug will stay at target levels in the bloodstream and decrease the ability of difficult to treat germs to resist, or not be killed by, the treatment using this antibiotic (meropenem) or other antibiotics.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

500

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Onset or exacerbation of pneumonia at least 72 hours after admission to an acute care facility or onset of pneumonia in a nursing home or rehabilitation facility with subsequent transfer to an acute care facility
Diagnosis of hospital-acquired pneumonia requiring mechanical ventilatory support
Patient or Patient's legal guardian must sign written informed consent for study participation, pretreatment, and Day 7 bronchoscopy

Exclusion Criteria:

Patients with hospital-acquired pneumonia caused by pathogens resistant to MERREM
Patients with allergies to cephalosporins, penicillins and carbapenems
Patients taking anticonvulsant therapy for a known seizure disorder
Patients with lung cancer
Patients with cystic fibrosis, acquired immune deficiency syndrome (AIDS), neutropenia, active tuberculosis, or patients taking immunosuppressive therapy in preparation for or following an organ transplant.
Patients who are pregnant or breast feeding
Patients who are unlikely to survive
Patients with certain infections in another area requiring treatment with additional antibiotics
Patients with other underlying conditions that would make it difficult to interpret response to study drug.
Patients who have been part of another clinical study 30 days before entry into this study.
Patients with hypotension (systolic BP < 85mmHg) or acidosis (arterial pH <7.25 or serum bicarbonate <15 mg/dl) despite attempts at fluid resuscitation
Patients with profound hypoxia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Type	Description	Arm Group Labels	Other Names
MERREM I.V. 2g as a 3 hour infusion every 8 hours	Drug
vancomycin I.V. 1 g every 12 hours	Drug
tobramycin I.V. 5 mg/kg every 24 hours	Drug
MERREM I.V. 1g as a 30 minute infusion every 8 hours	Drug
MERREM I.V. 500 mg as a 3 hour infusion every 8 hours	Drug

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D013845	Thienamycins
D015780	Carbapenems
D047090	beta-Lactams
D007769	Lactams
D000577	Amides
D009930	Organic Chemicals
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds