A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia

NCT00515034 | Completed Phase 2 Results

• 2 other identifiers: CR012934DORINOS2001
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the safety and tolerability of doripenem compared to imipenem in Ventilator-assisted pneumonia and complicated Intra-abdominal Infection. The study population will include hospitalized patients (or patients resident in a chronic health care facility) who have a diagnosis of either Ventilator associated pneumonia or complicated Intra-abdominal Infection.

Conditions

Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Pneumonia; Abdominal Abscess; Bacterial Infections

Keywords

Doripenem; Imipenem; Cilastatin; Vancomycin; DORIBAX, DORIPREX, FINIBAX, DURAPTA, PRIMAXIN, Anti Bacterial Agents; Ileus; Hospitalized; Fever

Outcome Measures

Primary Outcomes (1)

• Patients With Incidence of Treatment-emergent Adverse Events (TEAEs).

  Treatment-emergent adverse events (TEAEs) are defined as AEs with onset dates on or after the date of the start of the infusion of first dose of study therapy and within 30 days after administration of the last dose of study therapy.

  from the initiation of the first infusion of study drug therapy and up to 30 days after the completion of study drug therapy

Secondary Outcomes (2)

• Patients With VAP Who Were Clinically Cured

  7 to 14 days after the end of IV therapy

• Patients With cIAI Who Were Clinically Cured

  7 to 14 days after the end of IV therapy

Study Arms (4)

001

EXPERIMENTAL

Doripenem 1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion

Drug: Doripenem

002

ACTIVE COMPARATOR

Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion

Drug: Imipenem/cilastatin

003

EXPERIMENTAL

Doripenem 1 gram infused over 4 hours at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion

Drug: Doripenem

004

ACTIVE COMPARATOR

Imipenem/cilastatin 1 gram infused over 1 hour at 8 hour intervals for patients with complicated intrabdominal infections (cIAI) for 5 to 14 days Vancomycin may be added as adjunctive therapy as per investigator discretion

Drug: Imipenem/cilastatin

Interventions

Imipenem/cilastatin DRUG

Vancomycin and/or amikacin may be added as adjunctive therapy as per investigator discretion

002

Doripenem DRUG

1 gram infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7 to 14 days

001

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be hospitalized with a diagnosis of Ventilator-Assisted Pneumonia (VAP) or complicated Intra-Abdominal Infection (cIAI)
• Patients with VAP must have been hospitalized (or been in a chronic care facility) for \>= 5 days, have received mechanical ventilation for \>= 48 hours, have a Clinical Pulmonary Infection Score (CPIS) of \>= 5, have new or progressive radiographic infiltrates (not related to another disease process)
• Patients with cIAI must have clinical evidence of intra-abdominal infection, abdominal pain or tenderness, localized or diffuse abdominal wall rigidity, mass, ileus or have a requirement for surgical intervention (e.g., laparotomy, laparoscopic surgery, or percutaneous draining of an abscess) within 24 hours of study entry

You may not qualify if:

• Patients with a history of acute hepatic failure or acute decompensation of chronic hepatic failure, history of severe impairment of renal function, history of immunocompromising illness, acquired immunodeficiency syndrome (AIDS), or human immunodeficiency virus (HIV) with a CD4 count less than 200 cells/mL within the past 6 months
• organ (including bone marrow) transplant recipients
• hematologic malignancy
• use of immunosuppressive therapy at screening, including use of high dose corticosteroids (e.g., \> 40 mg prednisone or equivalent per day for \> 2 weeks)
• history of any rapidly progressing disease or immediately life-threatening illness (including acute hepatic failure and septic shock)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated; Pneumonia, Bacterial; Pneumonia; Abdominal Abscess; Bacterial Infections; Ileus; Fever

Interventions

Cilastatin, Imipenem Drug Combination; Doripenem

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections and Mycoses; Abscess; Suppuration; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Body Temperature Changes; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imipenem; Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Cilastatin; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

open-label study design and limited number of subjects in the comparator group

Results Point of Contact

• Title: Senior Director of Clinical Development
• Organization: Johnson and Johnson Pharmaceutical Research and Development L.L.C.

510 248-2310

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2007
• First Posted: August 13, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 19, 2019
• Results First Posted: June 22, 2010

Record last verified: 2011-05