Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DORIBAC4003 |
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The purpose of this study is to assess the safety and efficacy of doripenem in participants with nosocomial pneumonia (inflammation of the lungs in which the lungs become heavy; pneumonia occurring at least 48 hours after hospital admission), complicated intra-abdominal (in belly) infections and complicated urinary tract infections (bladder infections).
This is an open-label (all people involved know the identity of the intervention), multi-center (conducted in more than 1 center) study, to evaluate the safety and effectiveness of doripenem in treating Thai participants with nosocomial pneumonia, complicated intra-abdominal and urinary tract infections. The study consists of 4 visits: Visit 1 (Baseline), Visit 2 (End-of-Treatment [EOT], up to Day 14), Visit 3 (Phone visit, Test-of-Cure [TOC], up to Day 14 after EOT) and Visit 4 (Phone visit, Day 90). Participants will receive 500 milligram (mg) of doripenem as intravenous infusion (directly into the vein) every 8 hours for at least 3 days after clinical response and extended up to 14 days. Efficacy will primarily be evaluated by determination of clinical response. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nosocomial Pneumonia | Experimental | Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days. |
|
| Complicated Intra-Abdominal Infections | Experimental | Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days. |
|
| Complicated Urinary Tract Infections | Experimental | Doripenem will be administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doripenem | Drug | Doripenem 500 mg will be administered as 1 or 4 hours intravenous infusion, after every 8 hours up to maximum of 14 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs | An adverse event is any untoward medical occurrence in a participant administered with a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants discontinued because of AEs were also reported. | Up to 30 days after last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Response at End-of-Treatment (EOT) | Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required & no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms and require any other antimicrobial therapy; and Indeterminate=Insufficient data for treatment evaluation. 2 subjects were lost to follow-up. |
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Eligibility Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd.,Thailand Clinical Trial | Janssen-Cilag Ltd.,Thailand | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bangkok | Thailand | |||||
The total number of participants enrolled were 270, out of which 268 participants had adequate information for analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nosocomial Pneumonia | Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days. |
| FG001 | Complicated Intra-Abdominal Infections |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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|
| Up to Day 14 (EOT) |
| Percentage of Participants With Clinical Response at Test-of-Cure (TOC) | Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required and no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms & require any other antimicrobial therapy; & Indeterminate=Insufficient data for treatment evaluation. The TOC visit (up to Day 14 after EOT) was conducted by phone. Participants who were assessed as cure or improvement at EOT will be evaluated for clinical response at TOC (up to Day 14 after EOT). | Up to Day 14 after End-of-Treatment (EOT) |
| Number of Participants With 90-day Mortality | Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90. | up to Day 90 |
| Chiang Mai |
| Thailand |
| Chiang Rai | Thailand |
| Chon Buri | Thailand |
| Khon Kaen | Thailand |
| Nakhon Ratchasima | Thailand |
| Nakornnayok | Thailand |
| Pathum Thani | Thailand |
Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days. |
| FG002 | Complicated Urinary Tract Infections | Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
For Baseline characteristics, age and gender, number of participants evaluable was 264.
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| ID | Title | Description |
|---|---|---|
| BG000 | Entire Study Population |
| 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 |
|
| 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 | Number of Participants With Adverse Events (AEs) and Number of Participants Discontinued Because of AEs | An adverse event is any untoward medical occurrence in a participant administered with a pharmaceutical product. An adverse event does not necessarily have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants discontinued because of AEs were also reported. | Intent-to-treat population (ITT) included all participants who received at least one dose of study medication. | Posted | Number | Participants | Up to 30 days after last dose of study drug |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response at End-of-Treatment (EOT) | Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required & no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms and require any other antimicrobial therapy; and Indeterminate=Insufficient data for treatment evaluation. 2 subjects were lost to follow-up. | Clinical Modified-Intent-to-Treat (cMITT) included all participants who received any dose of study medication. "N" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively. | Posted | Number | Percentage of participants | Up to Day 14 (EOT) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response at Test-of-Cure (TOC) | Clinical response was defined as cure, improvement, failure and indeterminate. Cure=All signs/symptoms resolved/improved/lack of progression of all abnormalities; Improvement=Signs/symptoms of disease improved/resolved/ no modification in antibiotic therapy required and no worsening/appearance of new signs & symptoms of disease; Failure=Persistence or worsening of signs/symptoms of disease or emergence of new signs/symptoms & require any other antimicrobial therapy; & Indeterminate=Insufficient data for treatment evaluation. The TOC visit (up to Day 14 after EOT) was conducted by phone. Participants who were assessed as cure or improvement at EOT will be evaluated for clinical response at TOC (up to Day 14 after EOT). | The cMITT included all participants who received any dose of study medication. "N" signifies those participants who were evaluated for this measure at the specified time point for each arm group respectively. | Posted | Number | Percentage of Participants | Up to Day 14 after End-of-Treatment (EOT) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With 90-day Mortality | Number of Participants with 90-day mortality was defined as the number of participants who died by Day 90. | The cMITT included all participants who received any dose of study medication and met the clinical definition in the protocol. "N" signifies those participants who were evaluated for this measure. | Posted | Number | Participants | up to Day 90 |
|
Baseline up to 30 days after last dose of study drug
An adverse event is any untoward medical occurrence in a clinical study participant administered with study treatment. It can be any unfavorable and unintended sign/abnormal finding, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
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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 | Nosocomial Pneumonia | Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days. | 45 | 107 | 66 | 107 | ||
| EG001 | Complicated Intra-Abdominal Infections | Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days. | 14 | 34 | 22 | 34 | ||
| EG002 | Complicated Urinary Tract Infections | Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days. | 31 | 127 | 56 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Right ventricular failure | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Sudden cardiac death | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Colorectal cancer | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pancreatic carcinoma | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Acute hepatic failure | Hepatobiliary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Bile duct cancer | Hepatobiliary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hepatic neoplasm malignant | Hepatobiliary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Acquired immunodeficiency syndrome | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Bacterial sepsis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Fungal sepsis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| HIV infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Wound sepsis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Drug prescribing error | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Myasthenias | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypopharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Bladder cancer | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Lung cancer metastatic | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Agranulocytosis | Blood and lymphatic system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Oral candidiasis | Gastrointestinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hepatic encephalopathy | Hepatobiliary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Drug eruption | Immune system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Candida sepsis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Catheter related infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Fungal cystitis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Peritonitis bacterial | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Skin candida | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Stenotrophomonas infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Strongyloidiasis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Tinea cruris | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Application site itching | Injury, poisoning and procedural complications | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Transaminase increased | Investigations | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Metabolism and nutrition disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Gout | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Gouty arthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pyuria | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Renal and urinary disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Tracheobronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Cellulitis | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Tracheostomy | Surgical and medical procedures | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA Version 13.1 | Non-systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA Version 13.1 | Non-systematic Assessment |
|
If the Institution & Principal Investigator wish to publish information from Clinical Trial, a copy of manuscript must be provided to Sponsor at least 60 days prior to submission for publication/presentation & will arrange expedited reviews for the same. No paper with confidential Information will be submitted without Sponsor's prior consent. If requested, Institution & Principal Investigator will hold such publication for up to additional 60 days to allow filing of patent application.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Medical Affairs, Janssen-Cilag Ltd.,Thailand | 662-792-7200 |
| ID | Term |
|---|---|
| D007239 | Infections |
| D003428 | Cross Infection |
| D001424 | Bacterial Infections |
| D053717 | Pneumonia, Ventilator-Associated |
| D059413 | Intraabdominal Infections |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001423 | Bacterial Infections and Mycoses |
| D000077299 | Healthcare-Associated Pneumonia |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
|
| OG002 | Complicated Urinary Tract Infections | Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days. |
|
|
| OG002 | Complicated Urinary Tract Infections | Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|