Viewing Study NCT01122134


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Study NCT ID: NCT01122134
Status: UNKNOWN
Last Update Posted: 2010-05-13
First Post: 2010-05-10
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate for Severe Malaria Treatment
Sponsor: Makerere University
Organization:

Study Overview

Official Title: Pharmacokinetics and Pharmacodynamics of Intravenous Artesunate in Treatment of Severe Malaria in Ugandan Patients
Status: UNKNOWN
Status Verified Date: 2010-05
Last Known Status: NOT_YET_RECRUITING
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: Intravenous artesunate is highly effective with rapid schizonticidal action and improved clinical outcome
Detailed Description: The current first line treatment for severe malaria in Uganda is intravenous quinine with artemisinin derivatives as an alternative. Intravenous artesunate, a water soluble artemisinin derivative is more effective than quinine with faster schizonticidal action and improved clinical outcome. It is generally well tolerated and safe. This study aims is to assess the pharmacokinetics, pharmacodynamics and safety of IV artesunate in treatment of severe malaria in adults admitted to Mulago National Referral and Teaching hospital, Uganda.

Study Oversight

Has Oversight DMC: False
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?: