Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00076869
Status:
COMPLETED
Last Update Posted:
2015-01-13
First Post:
2004-02-05
Brief Title:
MK0991 in Combination With Standard Antifungal Agents for the Treatment of Salvage Invasive Aspergillosis 0991-037
Sponsor:
Merck Sharp Dohme LLC
Organization:
Merck Sharp Dohme LLC
Study Overview
Official Title:
A Multicenter Open Noncomparative Study to Estimate the Safety Tolerability and Efficacy of MK0991 in Combination With Amphotericin B Lipid Formulations of Amphotericin B or Azoles in the Treatment of Invasive Aspergillus Infection in Adults Who Are Refractory to or Intolerant of Standard Therapy
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Invasive aspergillosis is a type of fungal infection typically identified in very sick patients for example patients with cancer or who have had a bone marrow or organ transplant This study will seek to enroll patients 16 years of age or older with invasive aspergillosis infections involving organs or deep tissues who are failing or could not tolerate standard antifungal therapy Your doctor will make this determination based upon specific study criteria Patients that fulfill all study criteria will be treated daily with both the investigational drug and another antifungal agent The choice of the other agent is up to your doctor This investigational drug is approved for the treatment of invasive aspergillosis by itself The safety and efficacy of this investigational drug in combination with other agents is not known
Detailed Description:
The duration of treatment is 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006_400 | None | None | None |
| Formally-0121FI | None | None | None |