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| ID | Type | Description | Link |
|---|---|---|---|
| DORIINI2002 | Other Identifier | PriCara, Unit of Ortho-McNeil, Inc. |
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The purpose of this study is to evaluate the effectiveness and safety of doripenem monohydrate in the treatment of patients with nosocomial (hospital-acquired) pneumonia.
Nosocomial pneumonia (NP) accounts for approximately 15% of all hospital-acquired infections. The incidence of NP rises in patients who are on breathing machines. The death rate for NP can be as high as 30%. NP caused by bacteria, such as Pseudomonas aeruginosa, has been associated with an increased death rate compared to other pathogens. Prompt use of appropriate antibiotics is essential. Compounding the issue of nosocomial infections is the increasing rate to which bacteria develop resistance to antibiotics. This hospital based trial is studying doripenem in patients who have nosocomial pneumonia to see if it is effective against bacteria associated with this serious bacterial infection. The duration of treatment can be anywhere from 8 to 14 days. Safety evaluations, such as vital signs and laboratory tests will be performed upon enrollment, after 4 days on therapy, after 9 days on therapy for those on greater than 8 days, at the end of therapy, 7 to 14 days after the end of therapy, and 28 to 35 days after the end of therapy. Adverse events will be collected throughout the study. Clinical response to doripenem therapy will be assessed 7 to 14 days after the end of therapy and the long-term clinical response to doripenem therapy will be assessed 28 to 35 days after the end of therapy. Doripenem IV will be administered for a duration of treatment from 8 to 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Doripenem | Experimental | 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| doripenem | Drug | 1g i.v. infused over 4 hours every 8 hours for 8 to 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment. | The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection. | 5 to 21 days after the last dose of study therapy, or at early termination. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rates at the Late Follow-up Assessment. | The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection. | 28 to 35 days after last dose of study therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PriCara, Unit of Ortho-McNeil, Inc. Clinical Trial | PriCara, Unit of Ortho-McNeil, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palm Springs | California | United States | ||||
Two enrolled subjects didn't take study medication and weren't qualified for safety population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Doripenem | 1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period |
|
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| San Francisco |
| California |
| United States |
| Denver | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Jacksonville | Florida | United States |
| Miami | Florida | United States |
| Atlanta | Georgia | United States |
| Decatur | Georgia | United States |
| Hazard | Kentucky | United States |
| Baltimore | Maryland | United States |
| Springfield | Massachusetts | United States |
| Grand Rapids | Michigan | United States |
| Columbia | Missouri | United States |
| St Louis | Missouri | United States |
| Omaha | Nebraska | United States |
| Buffalo | New York | United States |
| Flushing | New York | United States |
| Jamaica | New York | United States |
| Toledo | Ohio | United States |
| Providence | Rhode Island | United States |
| Johnson City | Tennessee | United States |
| Nashville | Tennessee | United States |
| Norfolk | Virginia | United States |
| Morgantown | West Virginia | United States |
| Buenos Aires | Argentina |
| Santa Fe | Argentina |
| Oshawa | Ontario | Canada |
| Chicoutimi | Quebec | Canada |
| Concepción | Chile |
| Avenija Gojka Suska 6 | Croatia |
| Zagreb | Croatia |
| Argenteuil 95 95 | France |
| Jaipur | India |
| Kozhikode | India |
| Manipal | India |
| Noida | India |
| Pune | India |
| Novosibirsk | Russia |
| Kharkiv | Ukraine |
| Ukraine Poltava | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| End of Therapy to Test of Cure |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Doripenem | 1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| race | Number | participants |
| |||||||||||||||||||||||
| ethnicity | Number | participants |
| |||||||||||||||||||||||
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Response Rates and 95% Confidence Intervals at the Test-of-Cure Assessment. | The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection. | Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment. | Posted | Number | 95% Confidence Interval | Percentage of participants | 5 to 21 days after the last dose of study therapy, or at early termination. |
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| Secondary | Clinical Response Rates at the Late Follow-up Assessment. | The table below shows the percentage of subjects who had a clinical response of "clinical cure" at the Late Follow-up Visit as assigned by the medical monitor. A clinical response of "clinical cure" is defined as no further antibacterial therapy needed for treatment of the infection. | Clinically Evaluable: Subset of the ITT population who received at least 5 days of study medication unless deemed a clinical failure with at least 2 full days of therapy, and excluding those subjects with a clinical outcome of Not Evaluable at the TOC assessment. | Posted | Number | Percentage of participants | 28 to 35 days after last dose of study therapy |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Doripenem | 1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment | 70 | 183 | 93 | 183 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Cardiac Arrest | Cardiac disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Cardio-Respiratory Arrest | Cardiac disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Cardiopulmonary Failure | Cardiac disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pericardial Effusion | Cardiac disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Ventricular Fibrillation | Cardiac disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Sickle Cell Anaemia | Congenital, familial and genetic disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Spondylolisthesis | Congenital, familial and genetic disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Impaired Gastric Emptying | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Localised Intraabdominal Fluid Collection | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pancreatic Fistula | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Multi-Organ Failure | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Ulcer | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
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| Candidiasis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Empyema | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Lung Infection Pseudomonal | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Meningitis Bacterial | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Meningoencephalitis Herpetic | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Postoperative Wound Infection | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Renal Abscess | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Retroperitoneal Abscess | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Wound Infection | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Feeding Tube Complication | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Head Injury | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Subdural Haematoma | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Traumatic Brain Injury | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Weaning Failure | Injury, poisoning and procedural complications | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Bile Duct Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Gastric Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Anoxic Encephalopathy | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Cerebral Ischaemia | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Coma | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Convulsion | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Psychomotor Hyperactivity | Nervous system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Obstructive Uropathy | Renal and urinary disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Acute Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Hydropneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pulmonary Oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Respiratory Arrest | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Rash Papular | Skin and subcutaneous tissue disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Air Embolism | Vascular disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Thrombocythaemia | Blood and lymphatic system disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Fungal Infection | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 10.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 10.1 | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Data Generation | Janssen Scientific Affairs, LLC | 908 927-2943 |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D018410 | Pneumonia, Bacterial |
| D053717 | Pneumonia, Ventilator-Associated |
| D003428 | Cross Infection |
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001423 | Bacterial Infections and Mycoses |
| D000077299 | Healthcare-Associated Pneumonia |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077726 | Doripenem |
| ID | Term |
|---|---|
| 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 |
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| OTHER |
|
| CHILE |
|
| CROATIA |
|
| FRANCE |
|
| INDIA |
|
| RUSSIA |
|
| UKRAINE |
|
| USA |
|
| BLACK OR AFRICAN AMERICAN |
|
| OTHER, SPECIFY |
|
| WHITE |
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| OTHER |
|
|
| Subjects with Healthcare Associated Pneumonia |
|
|