Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000741
Status:
WITHDRAWN
Last Update Posted:
2021-11-04
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of Methylprednisolone in the Treatment of Pneumocystis Carinii Pneumonia PCP in Children With AIDS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Controlled Randomized Trial to Study the Efficacy of Adjunctive Methylprednisolone for the Treatment of Pneumocystis Carinii Pneumonia PCP in Pediatric AIDS Patients
Status:
WITHDRAWN
Status Verified Date:
2021-10
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:
To determine the effect of methylprednisolone on respiratory failure in HIV-infected patients with presumed or confirmed pneumocystis carinii pneumonia who are stratified for presence or absence of respiratory failure at the time of randomization to the study
Detailed Description:
HIV-infected children are randomized to receive adjunctive therapy with intravenous methylprednisolone or placebo Treatment is administered for 10 days Primary antipneumocystis therapy with TMPSMX or systemic pentamidine is selected by the individual investigator and given for 21 days Patients are stratified at the time of randomization by the presence or absence of respiratory failure
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: