Viewing Study NCT00164216



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Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00164216
Status: COMPLETED
Last Update Posted: 2012-09-11
First Post: 2005-09-09

Brief Title: Efficacy and Effectiveness of Combined Therapy for Uncomplicated Malaria Treatment in Peru
Sponsor: Centers for Disease Control and Prevention
Organization: Centers for Disease Control and Prevention

Study Overview

Official Title: Evaluation of the Efficacy and Effectiveness of Combined Therapy With Mefloquine and Artesunate for Uncomplicated Malaria Treatment in the Loreto Region Amazon Basin Peru
Status: COMPLETED
Status Verified Date: 2012-09
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: This is a study of the efficacy and effectiveness of combination therapy for malaria due to P falciparum in the Loreto Department Iquitos Peru The investigators will enroll subjects 1 year-old who have a diagnosis of uncomplicated malaria due to P falciparum Patients will receive a treatment regimen consisting of mefloquine 25 mgkg per day for two days and artesunate 12 mgkg per day for three days Patients will be divided into two groups one will receive drugs under direct supervision and the other will be instructed on how to take the drugs by themselves Clinical and parasitologic response will be monitored for a follow-up period of 28 days The findings of this study will be used to guide the Ministry of Health in evaluating its national policy for P falciparum malaria treatment
Detailed Description: None

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