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NCT00099775 · ClinicalTrials.gov registry record · Phase 3
Caspofungin to Prevent Candidiasis in Adults in Hospital Intensive Care Units
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 1,200
- Enrollment target
NCT00099775: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00099775 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 1,200 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00099775, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,200 participants
- Enrollment target
Study Summary
This study will examine whether the anti-fungal drug caspofungin can prevent Candida infections in adult patients in intensive care units (ICUs). Caspofungin is approved to treat certain fungal infections, including fungal blood stream infections due to Candida. Because ICU patients are at high risk for Candida, it would be beneficial to have a preventive drug, thereby reducing complications due to infection. Patients 18 years of age or older who are not pregnant may be enrolled in this study on day 3 or 4 of their ICU admission if they have an expected stay of at least 2 additional days in the ICU. Participants are randomly assigned to treatment with either caspofungin or placebo (an inactive substance). Before treatment, patients have a medical history and physical examination. Blood and urine tests are done for routine tests and to look for fungal infection. Additional samples that may be collected to test for fungal infection include a rectal swab or stool sample; a wound culture if the patient has a wound, or a sputum culture in patients who have a tube in their throat to help with breathing or are producing sputum. Patients take caspofungin or placebo once a day for no more than 28 days. In addition, they undergo the following procedures: * Review of treatment side effects and medicines taken, daily during treatment, 1 week after treatment, and 2 weeks after treatment * Physical examination once a week, on the last day of treatment, and 1 week after treatment * Urine test once a week, on the last day of treatment, and 1 week after treatment to look for possible fungal infection * Blood tests twice a week, on the last day of treatment, 1 week after treatment, and 2 weeks after treatment for laboratory safety tests and to look for fungal infection * Collection of additional samples (rectal swab or stool sample, wound culture, or sputum sample) once a week, on the last day of treatment, and 1 week after treatment to look for possible fungal infection
Interventions
- DRUG Caspofungin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,200 participants |
| Start Date | 2004-12 |
| Est. Completion | 2005-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00099775
The ClinicalTrials.gov registry entry for NCT00099775 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Caspofungin is the first listed.
NCT00099775 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00099775 about?
NCT00099775 is a clinical study titled "Caspofungin to Prevent Candidiasis in Adults in Hospital Intensive Care Units". This study will examine whether the anti-fungal drug caspofungin can prevent Candida infections in adult patients in intensive care units (ICUs). Caspofungin is approved to treat certain fungal infections, including fungal blood stream infections due to Candida. Because ICU patients are at high risk...
What is the current status of trial NCT00099775?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,200 participants. The study started on 2004-12. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00099775?
The interventions under investigation include: Caspofungin (DRUG).
Who is sponsoring clinical trial NCT00099775?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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