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

NCT00543608 | Terminated Phase 2 DMC

• 1 other identifier: ICLA-20-PNE1
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Keywords

pneumonia; nosocomial pneumonia

Outcome Measures

Primary Outcomes (3)

• Efficacy: Clinical cure rate - comparison of the two iclaprim dosing regimens versus vancomycin

  at test of cure (TOC) visit

• Efficacy: Iclaprim clinical cure rates

  at TOC and end of therapy (EOT)

• Safety

Study Arms (3)

1

EXPERIMENTAL

Dose 1 iclaprim

Drug: iclaprim

2

EXPERIMENTAL

Dose 2 iclaprim

Drug: iclaprim

3

ACTIVE COMPARATOR

vancomycin

Drug: vancomycin

Interventions

iclaprim DRUG

1; 2

vancomycin DRUG

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arpida AG: lead

MeSH Terms

Conditions

Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Pneumonia

Interventions

iclaprim; Vancomycin

Condition Hierarchy (Ancestors)

Cross Infection; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• David Willms, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 11, 2007
• First Posted: October 15, 2007
• Study Start: November 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: February 13, 2009

Record last verified: 2009-02