A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit (0787B-092)

NCT00445094 | Completed Phase 4

• 2 other identifiers: 0787B-0922007_004
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is a comparison between MK0787B and standard therapy.

Conditions

Infection; Pneumonia

Outcome Measures

Primary Outcomes (1)

• A 30-day-survival rate in the intensive care unit evaluated by Acute Physiology and Chronic Health (APACH II) Disease Classification System II score

Interventions

MK0787B, imipenem/cilastatin sodium / Duration of Treatment: 7 Days DRUG

Comparator: amikacin / Duration of Treatment: 3 Days DRUG

Comparator: tazocin / Duration of Treatment: 3 Days DRUG

Comparator: vancomycin / Duration of Treatment: 3 Days DRUG

Eligibility Criteria

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

You may qualify if:

• Greater than 18 years of age
• Patient is diagnosed with nosocomial pneumonia

You may not qualify if:

• Immunological deficient patients
• Pregnant women and nursing mothers
• A fungus is identified before the study enrollment
• Received vancomycin or imipenem for more than 5 days before icu admission

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Links

• Click here to access a synopsis of the study results.

MeSH Terms

Conditions

Infections; Pneumonia

Interventions

Imipenem; Cilastatin; Duration of Therapy

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2007
• First Posted: March 8, 2007
• Study Start: November 1, 2006
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: February 17, 2017

Record last verified: 2017-02