Clinical Efficacy of Intravenous Iclaprim Versus Vancomycin in the Treatment of Hospital-Acquired, Ventilator-Associated, or Health-Care-Associated Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the clinical cure rates of two dosing regimens of iclaprim with vancomycin (every 12 hours \[q12h\]) in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP), or health-care-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

NCT00124020

Bacterial Pneumonia

COMPLETED PHASE3

Aerosolized Plus Intravenous vs. Intravenous Colistin for VAP Due to Pandrugs-resistant A. Baumannii in Neonates

NCT02806141

Pneumonia, Ventilator-Associated Colistin Adverse Reaction Infection Due to Multidrug Resistant Acinetobacter +1 more

TERMINATED PHASE3

Nebulized Ceftazidime and Amikacin in Ventilator Associated Pneumonia

NCT00786305

Pneumonia

COMPLETED PHASE2

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

NCT00050401

Pneumonia

COMPLETED PHASE3

Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus

NCT00107952

Bacterial Pneumonia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hospital-Acquired Pneumonia Ventilator-Associated Pneumonia Health-Care-Associated Pneumonia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Dose 1 iclaprim

Group Type EXPERIMENTAL

iclaprim

Intervention Type DRUG

2

Dose 2 iclaprim

Group Type EXPERIMENTAL

iclaprim

Intervention Type DRUG

3

vancomycin

Group Type ACTIVE_COMPARATOR

vancomycin

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

iclaprim

Intervention Type DRUG

vancomycin

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Suspected or confirmed acute bacterial pneumonia due to Gram-positive pathogens in one of the following subgroups:

* hospital-acquired pneumonia (HAP), i.e., pneumonia that occurs 48 hours or more after admission, which was not incubating at the time of admission; or
* ventilator-associated pneumonia (VAP), i.e., pneumonia that arises more than 48 hours after endotracheal intubation; or
* health-care-associated pneumonia (HCAP), i.e., pneumonia diagnosed within 48 hours of hospital admission, in a patient who fulfills at least one of the following criteria:

1. hospitalization for at least two days within 90 days of the current infection,
2. residence in a nursing home or long-term care facility,
3. recipient of intravenous antibiotic therapy, chemotherapy, or wound care within 30 days of the current infection

Exclusion Criteria

* Acute Physiology and Chronic Health Enquiry (APACHE) II score \< 8 or ≥ 25.
* Pneumonia not requiring empiric or targeted treatment effective against Gram-positive pathogens.
* Pulmonary infection due to Gram-positive organisms known to be resistant to either study medication prior to study entry.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No