Trial Outcomes & Findings for Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU) (NCT NCT00520234)

NCT ID: NCT00520234

Last Updated: 2011-05-09

Results Overview

Modified MSG/EORTC criteria for the diagnosis of fungal infections: Proven invasive candidiasis is defined as candidemia, Candida cultured from a sterile site, or histopathological evidence of candida infection. Probable invasive candidiasis is defined as 2 consecutive positive beta glucan levels in the presence of signs and symptoms of infection.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

222 participants

Primary outcome timeframe

Within 7 days after end of therapy

Results posted on

2011-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Prophylaxis Caspofungin 50 mg IV daily up to 28 days of therapy	Placebo Normal Saline 100 cc IV daily
Overall Study STARTED	118	104
Overall Study COMPLETED	117	102
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Study of Caspofungin Prophylaxis Followed by Pre-emptive Therapy for Invasive Candidiasis in the Intensive Care Unit (ICU)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prophylaxis n=117 Participants Caspofungin 50 mg IV daily up to 28 days of therapy	Placebo n=102 Participants Normal Saline 100 cc IV daily	Total n=219 Participants Total of all reporting groups
Age Continuous	58.2 years STANDARD_DEVIATION 17.5 • n=5 Participants	56.7 years STANDARD_DEVIATION 16.6 • n=7 Participants	57.5 years STANDARD_DEVIATION 17.1 • n=5 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	41 Participants n=7 Participants	87 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	61 Participants n=7 Participants	132 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	109 Participants n=5 Participants	94 Participants n=7 Participants	203 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants	60 Participants n=7 Participants	138 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Acute Physiology And Chronic Health Evaluation (APACHE) II score (minimum 0, maximum 71)	25.3 Score on a scale STANDARD_DEVIATION 8.0 • n=5 Participants	25.1 Score on a scale STANDARD_DEVIATION 8.7 • n=7 Participants	25.2 Score on a scale STANDARD_DEVIATION 8.3 • n=5 Participants

PRIMARY outcome

Timeframe: Within 7 days after end of therapy

Population: Modified intent-to-treat population, defined as subjects who received at least one dose of study drug and did not have baseline invasive candidiasis.

Outcome measures

Outcome measures
Measure	Prophylaxis n=102 Participants Caspofungin 50mg IV daily	Placebo n=84 Participants Normal Saline 100 cc IV daily
Proven and Probable Invasive Candidiasis Based on Modified Mycoses Study Group/European Organization for Research and Treatment of Cancer (MSG/EORTC) Criteria.	9.8 percent of participants	16.6 percent of participants

SECONDARY outcome

Timeframe: Up to 14 days after end of therapy

Population: Safety population, defined as all subjects who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Prophylaxis n=117 Participants Caspofungin 50mg IV daily	Placebo n=102 Participants Normal Saline 100 cc IV daily
Subjects Who Discontinue Study Therapy Due to a Drug-related Adverse Event	2 participants	2 participants

SECONDARY outcome

Timeframe: Up to 14 days after end of therapy

Population: Safety population, defined as all subjects who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Prophylaxis n=117 Participants Caspofungin 50mg IV daily	Placebo n=102 Participants Normal Saline 100 cc IV daily
Subjects With 1 or More Serious Drug-related Adverse Event(s)	1 participants	0 participants

Adverse Events

Prophylaxis

Serious events: 33 serious events

Other events: 106 other events

Deaths: 0 deaths

Placebo

Serious events: 28 serious events

Other events: 87 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Luis Ostrosky-Zeichner, MD

Mycoses Study Group

Phone: (713) 500-6733

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Prophylaxis n=117 participants at risk Caspofungin 50 mg IV daily up to 28 days of therapy	Placebo n=102 participants at risk Normal Saline 100 cc IV daily
Cardiac disorders Atrioventricular extrasystoles	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Congenital, familial and genetic disorders Bradyarrhythmia	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Cardiac disorders Bradycardia	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Cardiac disorders Cardiac arrest	2.6% 3/117 • Within 14 days of completion of study therapy.	2.9% 3/102 • Within 14 days of completion of study therapy.
Cardiac disorders Cardiac failure congestive	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Cardiac disorders Cardiomyopathy acute	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Cardiac disorders Cardio-respiratory arrest	3.4% 4/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Cardiac disorders Electromechanical dissociation	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Gastrointestinal disorders Chronic gastrointestinal bleeding	1.7% 2/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Gastrointestinal disorders Intestinal haemorrhage	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Gastrointestinal disorders Pneumoperitoneum	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
General disorders Multi-organ failure	0.00% 0/117 • Within 14 days of completion of study therapy.	2.0% 2/102 • Within 14 days of completion of study therapy.
General disorders Sudden death	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Infections and infestations Abdominal sepsis	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Infections and infestations Sepsis	6.8% 8/117 • Within 14 days of completion of study therapy.	2.9% 3/102 • Within 14 days of completion of study therapy.
Infections and infestations Septic shock	6.0% 7/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Investigations Transaminases increased	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Metabolism and nutrition disorders Hyperkalaemia	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Nervous system disorders Brain stem infarction	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Nervous system disorders Grand mal convulsion	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Nervous system disorders Haemorrhage intracranial	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Nervous system disorders Haemorrhagic stroke	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Nervous system disorders Ischaemic stroke	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Nervous system disorders Metabolic encephalopathy	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Nervous system disorders Spinal cord infarction	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Renal and urinary disorders Renal failure	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.85% 1/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Respiratory arrest	0.00% 0/117 • Within 14 days of completion of study therapy.	2.0% 2/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Respiratory distress	2.6% 3/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Respiratory failure	3.4% 4/117 • Within 14 days of completion of study therapy.	2.0% 2/102 • Within 14 days of completion of study therapy.
Vascular disorders Deep vein thrombosis	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Vascular disorders Flushing	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Vascular disorders Hypotension	0.85% 1/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Vascular disorders Peripheral ischaemia	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.
Vascular disorders Shock	0.00% 0/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.

Measure	Prophylaxis n=117 participants at risk Caspofungin 50 mg IV daily up to 28 days of therapy	Placebo n=102 participants at risk Normal Saline 100 cc IV daily
Blood and lymphatic system disorders Anaemia	12.0% 14/117 • Within 14 days of completion of study therapy.	12.7% 13/102 • Within 14 days of completion of study therapy.
Blood and lymphatic system disorders Leukocytosis	12.0% 14/117 • Within 14 days of completion of study therapy.	6.9% 7/102 • Within 14 days of completion of study therapy.
Blood and lymphatic system disorders Thrombocytopenia	6.0% 7/117 • Within 14 days of completion of study therapy.	3.9% 4/102 • Within 14 days of completion of study therapy.
Gastrointestinal disorders Diarrhoea	5.1% 6/117 • Within 14 days of completion of study therapy.	5.9% 6/102 • Within 14 days of completion of study therapy.
General disorders Pyrexia	15.4% 18/117 • Within 14 days of completion of study therapy.	5.9% 6/102 • Within 14 days of completion of study therapy.
Infections and infestations Bacteraemia	4.3% 5/117 • Within 14 days of completion of study therapy.	6.9% 7/102 • Within 14 days of completion of study therapy.
Infections and infestations Sepsis	7.7% 9/117 • Within 14 days of completion of study therapy.	4.9% 5/102 • Within 14 days of completion of study therapy.
Infections and infestations Septic shock	6.8% 8/117 • Within 14 days of completion of study therapy.	0.00% 0/102 • Within 14 days of completion of study therapy.
Investigations Blood urea increased	5.1% 6/117 • Within 14 days of completion of study therapy.	2.9% 3/102 • Within 14 days of completion of study therapy.
Investigations Hepatic enzyme increased	11.1% 13/117 • Within 14 days of completion of study therapy.	2.9% 3/102 • Within 14 days of completion of study therapy.
Musculoskeletal and connective tissue disorders Hyperglycaemia	5.1% 6/117 • Within 14 days of completion of study therapy.	3.9% 4/102 • Within 14 days of completion of study therapy.
Metabolism and nutrition disorders Hyperkalaemia	2.6% 3/117 • Within 14 days of completion of study therapy.	5.9% 6/102 • Within 14 days of completion of study therapy.
Metabolism and nutrition disorders Hypoglycaemia	7.7% 9/117 • Within 14 days of completion of study therapy.	6.9% 7/102 • Within 14 days of completion of study therapy.
Metabolism and nutrition disorders Hypokalaemia	9.4% 11/117 • Within 14 days of completion of study therapy.	2.9% 3/102 • Within 14 days of completion of study therapy.
Metabolism and nutrition disorders Hyponatraemia	3.4% 4/117 • Within 14 days of completion of study therapy.	5.9% 6/102 • Within 14 days of completion of study therapy.
Metabolism and nutrition disorders Hypophosphataemia	6.8% 8/117 • Within 14 days of completion of study therapy.	2.9% 3/102 • Within 14 days of completion of study therapy.
Psychiatric disorders Agitation	6.0% 7/117 • Within 14 days of completion of study therapy.	3.9% 4/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Pleural effusion	9.4% 11/117 • Within 14 days of completion of study therapy.	3.9% 4/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Respiratory distress	6.0% 7/117 • Within 14 days of completion of study therapy.	2.9% 3/102 • Within 14 days of completion of study therapy.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.0% 7/117 • Within 14 days of completion of study therapy.	3.9% 4/102 • Within 14 days of completion of study therapy.
Skin and subcutaneous tissue disorders Decubitus ulcer	2.6% 3/117 • Within 14 days of completion of study therapy.	5.9% 6/102 • Within 14 days of completion of study therapy.
Vascular disorders Deep vein thrombosis	8.5% 10/117 • Within 14 days of completion of study therapy.	0.98% 1/102 • Within 14 days of completion of study therapy.