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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002084-26 | EudraCT Number | ||
| MK-0991-064 | Other Identifier | Merck Protocol Number |
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Operational feasibility with low recruitment due to changing epidemiology of disease
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The study will evaluate the safety, tolerability, and efficacy of caspofungin as compared with amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants. The primary hypothesis to be tested in the study is that caspofungin will be superior to amphotericin B deoxycholate with regard to the proportion of participants with fungal-free survival at the 2-week post-therapy follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caspofungin | Experimental | Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment |
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| Amphotericin B Deoxycholate | Active Comparator | Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caspofungin | Drug |
| ||
| Amphotericin B Deoxycholate |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period | Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved. | Up to 104 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Fungal-free Survival Through the End of Study Treatment | Fungal-free survival is those participants who survived up to end of study treatment, and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31586424 | Result | Kim J, Nakwa FL, Araujo Motta F, Liu H, Dorr MB, Anderson LJ, Kartsonis N. A randomized, double-blind trial investigating the efficacy of caspofungin versus amphotericin B deoxycholate in the treatment of invasive candidiasis in neonates and infants younger than 3 months of age. J Antimicrob Chemother. 2020 Jan 1;75(1):215-220. doi: 10.1093/jac/dkz398. |
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Participants less than 3 months of age with invasive candidiasis were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caspofungin | Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment |
| FG001 | Amphotericin B Deoxycholate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 27, 2013 |
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| Up to 90 days |
| Number of Participants With an Adverse Event (AE) | An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE. | 8 weeks after end of study therapy (up to 146 days) |
Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Caspofungin | Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment |
| BG001 | Amphotericin B Deoxycholate | Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Days |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Weight | Weight at Baseline Measurement | Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis. | Mean | Standard Deviation | Grams |
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| 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 | Percentage of Participants With Fungal-free Survival Through the 2-week Post-therapy Period | Fungal-free survival is those participants who survived up to 2 weeks post-therapy, and had documented microbiological eradication of Candida species (sp.) from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved. | Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 104 days |
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| Secondary | Percentage of Participants With Fungal-free Survival Through the End of Study Treatment | Fungal-free survival is those participants who survived up to end of study treatment, and had documented microbiological eradication of Candida sp. from follow-up cultures collected after the initiation of study therapy. Microbiological eradication denotes negative follow-up cultures for Candida sp. from the site of infection. If a culture is not obtained on the day of assessment, the last culture after study entry may be used to assist in the assessment of microbiological eradication. If the last culture is negative for Candida sp., then microbiological eradication would be considered achieved. | Participants who received at least 1 full dose of study therapy and had a documented (culture-confirmed) diagnosis of invasive candidiasis. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 90 days |
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| Secondary | Number of Participants With an Adverse Event (AE) | An AE is any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR's product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the SPONSOR's product, is also an AE. | All participants as treated | Posted | Count of Participants | Participants | 8 weeks after end of study therapy (up to 146 days) |
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8 weeks after end of study therapy (up to 146 days)
All participants as treated
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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 | Caspofungin | Caspofungin 2 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment | 2 | 33 | 7 | 33 | 23 | 33 |
| EG001 | Amphotericin B Deoxycholate | Amphotericin B deoxycholate 1 mg/kg intravenous once daily for ≥14 days after documented negative culture and improvement of clinical signs and symptoms, for a maximum of 90 days treatment | 3 | 16 | 9 | 16 | 15 | 16 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Cardio-respiratory arrest | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Intestinal obstruction | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Necrotising colitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Necrotising enterocolitis neonatal | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Bacterial sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Bronchiolitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Device related sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Endocarditis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Escherichia sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Meningitis bacterial | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Pneumonia escherichia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Anastomotic complication | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Suture rupture | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Superior vena cava syndrome | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Leukostasis syndrome | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
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| Eye discharge | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Anal fissure | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Necrotising enterocolitis neonatal | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypothermia | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Cholestasis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
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| Abscess limb | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Septic shock | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Staphylococcal sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood alkaline phosphatase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood bilirubin unconjugated increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood potassium increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Blood triglycerides increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Oxygen saturation decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Feeding intolerance | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypernatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypochloraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Seizure | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Glycosuria | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
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| Renal tubular necrosis | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
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| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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The trial was terminated early due to operational feasibility with low recruitment due to changing epidemiology of disease.
The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| Jul 30, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D058365 | Candidiasis, Invasive |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D000072742 | Invasive Fungal Infections |
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| ID | Term |
|---|---|
| D000077336 | Caspofungin |
| C059765 | amphotericin B, deoxycholate drug combination |
| ID | Term |
|---|---|
| D055666 | Lipopeptides |
| D008055 | Lipids |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D054714 | Echinocandins |
| D010456 | Peptides, Cyclic |
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| Units | Counts |
|---|---|
| Participants |
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