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Generic Protocols and Flow Diagram for in vivo Antimalarial Drug-Efficacy Studies in the Americas

The Amazon Network for the Surveillance of Antimalarial Drug Resistance (RAVREDA) es a joint effort on the part of eight countries of the Amazon region with the Pan American Health Organization (PAHO) and the US Agency for International Development's (USAID's) Amazon Malaria Initiative (AMI), with technical support from the Centers for Disease Control and Prevention (CDC). The main area of work of RAVREDA/AMI is regional consolidation of a network of sentinel sites to evaluate the therapeutic efficacy of treatment schemes currently in use and of antimalarial drugs that could be introduced into the Region. The results of efficacy evaluations that have been carried out within the framework of RAVREDA since 2002 have already permitted countries to improve their policies on antimalarials. In September 2003—in a meeting held in Iquitos, Peru, involving eight countries of the region, PAHO, USAID, and CDC—an evaluation was carried out on the protocols used by RAVREDA to evaluate therapeutic effectiveness in treating uncomplicated Plasmodium falciparum and Plasmodium vivax malaria. Modifications were introduced based on the latest WHO recommendations on how to carry out this type of studies in areas of low transmission (WHO/CDS/CSR/EPH/2002.17).

     
Enlace relacionado:

:: Global Plan for Artemisinin Resistance containment (En Inglés)


Researchers from the Region have developed a guide with instructions and practical recommendations to facilitate the efficacy protocols, taking into account the peculariarities of the Amazon region. This guide can be very helpful in organizing and planning study execution and in guaranteeing strict compliance with the methodology established in the protocols.

Project Descriptions (with links to protocols and flow diagram)

1. Title: Efficacy of Chloroquine and Sulfadoxine-Pyrimethamine for the Treatment of Uncomplicated Plasmodium falciparum Malaria

Objective: Assess the efficacy of chloroquine and sulfadoxine-pyrimethamine for the treatment of uncomplicated P. falciparum infections.

Methods: This concerns an in vivo antimalarial drug-efficacy trial. Subjects > 6 months of age with parasitologically-confirmed, uncomplicated P. falciparum infections. Patients will be treated with either chloroquine (25 mg/kg over three days) or with sulfadoxine/pyrimethamine (25 mg/kg of the sulfadoxine component in a single dose). (For comparative studies: Patients will be randomly assigned one of the two drugs regimens). Clinical and parasitologic parameters will be monitored over a (14/28)-day follow-up period to evaluate drug efficacy. Results from this study will be used to assist the Ministry of Health in assessing their national malaria treatment policy for P. falciparum malaria.   Protocol 

2. Title: Efficacy and Safety of Mefloquine and Mefloquine-Artesunate Combination Therapy for the Treatment of Uncomplicated Plasmodium falciparum Malaria

Objectives:

:: Assess the efficacy and safety of mefloquine alone and mefloquine-artesunate combination therapy for the treatment of uncomplicated P. falciparum infections.

:: Evaluate the impact of mefloquine alone and mefloquine-artesunate therapy on gametocytemia.

Methods: This concerns an in vivo antimalarial drug-efficacy trial. Subjects > 6 months of age with parasitologically-confirmed, uncomplicated P. falciparum infections will be assigned at random to be treated with either mefloquine (25 mg/kg in two divided doses) or mefloquine (25 mg/kg in two divided doses) plus artesunate (12 mg/kg over 3 days). Clinical and parasitologic parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy and safety. Results from this study will be used to assist the Ministry of Health in assessing their national malaria treatment policy for P. falciparum malaria.

Protocol   |   Flow Diagram

3. Title: Efficacy of Chloroquine for the Treatment of Plasmodium vivax Malaria

Objective: Assess the efficacy of chloroquine for the treatment of P. vivax infections.

Methods: This concerns an in vivo drug-efficacy study. Subjects > 6 months of age with parasitologically-confirmed P. vivax infections will be treated under supervision with chloroquine, 25 mg/kg over three days. Clinical and parasitologic parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy. Blood samples will be taken to measure the CQ level in blood and to genotype parasites that appear after Day 3. Results from this drug efficacy study will be used to assist the Ministry of Health in assessing their national malaria treatment policy for P. vivax malaria.   Protocol



Last Updated on Monday, 21 October 2013 17:32

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