Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00229775
Status:
COMPLETED
Last Update Posted:
2012-09-11
First Post:
2005-09-28
Brief Title:
Efficacy of Chloroquine Sulfadoxine Pyrimethamine Versus Artemether Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Efficacy of Chloroquine Sulfadoxine Pyrimethamine Versus Artemether Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Philippines
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:
The purpose of this study is to determine whether artemether lumefantrine is as effective as chloroquine sulfadoxine pyrimethamine in the treatment of uncomplicated Plasmodium falciparum malaria
Detailed Description:
Background In the Philippines close to 11 million people in 65 provinces are at risk for acquiring malaria infections It is still one of the ten leading causes of morbidity nationwide Each day roughly 150-200 people fall ill with malaria In the past 40 years the mortality rate stabilized at around 2100000 population Of those people who have malaria approximately 1 die per year Malaria remains one of the major causes of death in provinces such as Palawan Isabela Tawi-tawi Sulu and Butuan City Approximately 70 of all malaria in the Philippines is Plasmodium falciparum with the remaining species being P vivax
Recently the Department of Health DOH instituted a change in the national antimalarial drug guidelines changing from using chloroquine CQ and sulfadoxine pyrimethamine SP monotherapy as first and second line drugs respectively to a combined chloroquine plus sulfadoxine-pyrimethamine as first-line treatment and artemether-lumefantrine Coartem as second line treatment This change was made due to increasing levels of drug resistance to the previous first and second-line therapies In order to have an improved understanding of the trends of antimalarial drug resistance in the Philippines the DOH is initiating a sentinel surveillance system for monitoring of antimalarial drug resistance Three sites have been selected to be representative of the country
Objective To establish a sentinel surveillance system to assess the efficacy of chloroquine plus sulfadoxine-pyrimethamine versus artemether lumefantrine for the treatment of uncomplicated P falciparum infections in three areas of the Republic of the Philippines
Methods An in vivo antimalarial drug efficacy trial will be conducted in three areas of the Philippines Subjects 6 months of age with parasitologically confirmed uncomplicated P falciparum infections will be recruited Patients will be treated with single dose SP 25 mgkg of the sulfadoxine component in a single dose plus CQ 25 mgkg over three days or artemether lumefantrine twice daily over 3 days Patients will be randomly assigned one of the two drugs regimens Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy Results from this study will be used to assist the DOH in assessing their national malaria treatment policy for P falciparum malaria
Recently the Department of Health DOH instituted a change in the national antimalarial drug guidelines changing from using chloroquine CQ and sulfadoxine pyrimethamine SP monotherapy as first and second line drugs respectively to a combined chloroquine plus sulfadoxine-pyrimethamine as first-line treatment and artemether-lumefantrine Coartem as second line treatment This change was made due to increasing levels of drug resistance to the previous first and second-line therapies In order to have an improved understanding of the trends of antimalarial drug resistance in the Philippines the DOH is initiating a sentinel surveillance system for monitoring of antimalarial drug resistance Three sites have been selected to be representative of the country
Objective To establish a sentinel surveillance system to assess the efficacy of chloroquine plus sulfadoxine-pyrimethamine versus artemether lumefantrine for the treatment of uncomplicated P falciparum infections in three areas of the Republic of the Philippines
Methods An in vivo antimalarial drug efficacy trial will be conducted in three areas of the Philippines Subjects 6 months of age with parasitologically confirmed uncomplicated P falciparum infections will be recruited Patients will be treated with single dose SP 25 mgkg of the sulfadoxine component in a single dose plus CQ 25 mgkg over three days or artemether lumefantrine twice daily over 3 days Patients will be randomly assigned one of the two drugs regimens Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy Results from this study will be used to assist the DOH in assessing their national malaria treatment policy for P falciparum malaria
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 |
|---|---|---|---|
| U30CCU317876-01 | None | None | None |