Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00373607
Status:
COMPLETED
Last Update Posted:
2010-09-14
First Post:
2006-09-07
Brief Title:
Efficacy and Safety of DihydroartemisininPiperaquine Artekin for the Treatment of Uncomplicated Malaria in Peru
Sponsor:
Institute of Tropical Medicine Belgium
Organization:
Institute of Tropical Medicine Belgium
Study Overview
Official Title:
Phase 3a Efficacy Safety and Tolerability of DihydroartemisininPiperaquine Artekin for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in the Peruvian Amazon Region
Status:
COMPLETED
Status Verified Date:
2010-09
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:
In Peru Mefloquine plus Artesunate MAS3 is the current first line treatment for P falciparum malaria in the Amazonian Region and has proved its efficacy against multi-resistant P falciparum parasites but several side effects have been reported Dihydroartemisinin-piperaquine DHA-PPQ is a new co-formulated and well tolerated ACT increasingly used in Southeast Asia where it has proved to be highly effective against Plasmodium falciparum malaria We tested the efficacy safety and tolerability of DHA-PPQ in patients with uncomplicated P falciparum malaria A RCT to evaluate DHA-PPQ was carried out between 2003 and 2005 Patients with uncomplicated P falciparum malaria were randomly allocated to receive either DHA-PPQ or MAS3 with a 63-day follow-up period Five hundred twenty two patients were included in the analysis 262 were allocated to receive DHA-PPQ and 260 to receive MAS3 The two groups were comparable at baseline in demographic and clinical characteristics The mean time for parasite clearance into the DHA-PPQ group was 320 hours and 355 hours in the MAS3 group Twenty-four hours after the first dose the proportions of patients whose cleared parasitaemia were 672 in the DHA-PPQ group and 581 in the MAS3 group RR 125 95 CI 103-152 p 0017 All patients were able to clear parasites within 72 hours after the first dose The mean time for fever clearance was 280 and 295 hours in DHA-PPQ and MAS3 group respectively P 069 Twenty-four hours after the first dose 855 and 831 of patients cleared fever in the DHA-PPQ and MAS3 group respectively p005 The Adequate Clinical and Parasitological Response ACPR PCR adjusted were 977 and 992 for the DHA-PPQ and MAS3 group respectively RR 099 95 CI 086-113 P 088 No Early Treatments Failures were reported in any group In the DHA-PPQ group according to the PCR adjusted results 6 subjects had Late treatment Failures In the MAS3 group two Late Treatment Failures was reported The frequency of adverse events was significantly lower in patients treated with DHA-PPQ than in those treated with MAS3
DHA-PPQ proved to be a highly effective antimalarial drug for the treatment of P falciparum malaria and suitable for use in the Peruvian Amazon region It also has the advantage of being better tolerated In terms of cost DHA-PPQ is cheaper and more affordable than MAS3 and should be considered for the National Antimalarial Drug Policy in Perú
DHA-PPQ proved to be a highly effective antimalarial drug for the treatment of P falciparum malaria and suitable for use in the Peruvian Amazon region It also has the advantage of being better tolerated In terms of cost DHA-PPQ is cheaper and more affordable than MAS3 and should be considered for the National Antimalarial Drug Policy in Perú
Detailed Description:
In Peru Mefloquine plus Artesunate MAS3 is the current first line treatment for P falciparum malaria in the Amazonian Region and has proved its efficacy against multi-resistant P falciparum parasites but several side effects have been reported Dihydroartemisinin-piperaquine DHA-PPQ is a new co-formulated and well tolerated ACT increasingly used in Southeast Asia where it has proved to be highly effective against Plasmodium falciparum malaria We tested the efficacy safety and tolerability of DHA-PPQ in patients with uncomplicated P falciparum malaria A RCT to evaluate DHA-PPQ was carried out between 2003 and 2005 Patients with uncomplicated P falciparum malaria were randomly allocated to receive either DHA-PPQ or MAS3 with a 63-day follow-up period Five hundred twenty two patients were included in the analysis 262 were allocated to receive DHA-PPQ and 260 to receive MAS3 The two groups were comparable at baseline in demographic and clinical characteristics The mean time for parasite clearance into the DHA-PPQ group was 320 hours and 355 hours in the MAS3 group Twenty-four hours after the first dose the proportions of patients whose cleared parasitaemia were 672 in the DHA-PPQ group and 581 in the MAS3 group RR 125 95 CI 103-152 p 0017 All patients were able to clear parasites within 72 hours after the first dose The mean time for fever clearance was 280 and 295 hours in DHA-PPQ and MAS3 group respectively P 069 Twenty-four hours after the first dose 855 and 831 of patients cleared fever in the DHA-PPQ and MAS3 group respectively p005 The Adequate Clinical and Parasitological Response ACPR PCR adjusted were 977 and 992 for the DHA-PPQ and MAS3 group respectively RR 099 95 CI 086-113 P 088 No Early Treatments Failures were reported in any group In the DHA-PPQ group according to the PCR adjusted results 6 subjects had Late treatment Failures In the MAS3 group two Late Treatment Failures was reported The frequency of adverse events was significantly lower in patients treated with DHA-PPQ than in those treated with MAS3
DHA-PPQ proved to be a highly effective antimalarial drug for the treatment of P falciparum malaria and suitable for use in the Peruvian Amazon region It also has the advantage of being better tolerated In terms of cost DHA-PPQ is cheaper and more affordable than MAS3 and should be considered for the National Antimalarial Drug Policy in Perú
DHA-PPQ proved to be a highly effective antimalarial drug for the treatment of P falciparum malaria and suitable for use in the Peruvian Amazon region It also has the advantage of being better tolerated In terms of cost DHA-PPQ is cheaper and more affordable than MAS3 and should be considered for the National Antimalarial Drug Policy in Perú
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