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Phase: ongoing - Le promoteur: Drugs for Neglected Diseases initiative (DNDi) (Switzerland)
Drugs for Neglected Diseases initiative (DNDi) (Switzerland) MAJ Il y a 4 ans

Efficacy, safety and population pharmacokinetics of artesunate-mefloquine combination for the treatment of uncomplicated falciparum malaria in African children versus artemether-lumefantrine Background and study aims We are conducting a study on a new malaria combination drug called artesunate-mefloquine. This drug will be used by sick children who are able to take the drug orally. Available information about this drug, which comes mostly from the use of this drug in East Asia and Southern American countries, indicates that the artesunate-mefloquine combination is better and safe for children. However, we need to understand more about the safety of this combination drug in the African continent, where this information is rare. It is for this reason that this study is conducted. Who can participate? Children aged between 6 and 59 months, either sex, with uncomplicated falciparum malaria. What does the study involve? Patients will be divided into two groups to ensure that each participant has an equal chance of being in either group (like a lottery). Half of the children will be given the trial drug artesunate-mefloquine (ASMQ) and the other half will be given a combination drug with a known efficacy (i.e. artemether-lumefantrine, AL) in order to be able to compare the results of the current malaria drug and the new drug. At the first visit your child will be seen by a doctor and a small amount of blood (less than a teaspoon) will be drawn from her/his hand to verify if the child has malaria parasites and to check the health status. This initial investigation will help us to know if your will be able to participate or not. Following this stage, your child will receive treatment based on the assigned group as described above. Blood from a finger prick to follow the malaria parasites will be taken every eight hours until the malaria parasites are not seen. Your child will be admitted in the ward not less than 3 days until she/he receive the last dose of malaria drug. A blood sample will be taken once again from the finger at days 1, 2, 3, 7, 14, 21, 28, 35, 42,49, 56 and 63 when the child will be brought for follow up. The doctor will see and examine your child during all these 12 visits. An extra blood sample will be taken during the investigation of your child on days 7, 28 and 63 and any other sample will be taken only if it is needed for the child’s treatment. Also, on day 0 (i.e. before the first dose) and day 7, a sample will be taken from every child to test the amount of drug in the child’s body, as well as the last day if the child has recurrence of parasitemia. A total of 100 children (50 in each group, ASMQ and AL) will be selected out of the 940 for follow up of drug levels in the child’s body. For the 50 children in ASMQ group, four additional samples will be taken on day 0 (after the first dose), day 2 (after the third dose), day 3, and either on day 28, 35, 42, 49, 56 or 63. For the 50 patients in the AL group, two additional samples will be taken on day 3 and either on day 28, 35, 42, 49, 56 or 63. You may stay with your child during the treatment, follow-up and in all stages. The child will be in the study for a total of nine weeks. In case of recurrent parasitaemia during the efficacy follow-up period (63 days), your child will be treated with the investigational product of the other arm. For example, if your child has received Coartem he would receive ASMQ, and vice versa, and follow-up of 63 days will recommence after the day of failure in order to supervise the progression. Three visits will be performed during this follow-up: at 7, 28 and 63 days. The following assessments will be done during these three visits and any other day if you return spontaneously: blood from a finger prick to follow the malaria parasites and recording of eventual adverse effects and concomitant medications. What are the possible benefits and risks of participating? If you agree for your child to participate in this study, you may have the following benefits: the child will be watched closely for a period of more than six weeks and in case of any sickness during that period, she/he will be given treatment without any cost. Also, participating in this study could help to understand if the combination drug artesunate-mefloquine is better and safe for African children and this will facilitate availability of this drug in African countries where children are dying of malaria.Incentives will not be provided to persuade people to participate in this study; however, to value your time and recognize your participation in this study; we will pay the treatment costs for your child in this hospital during the study period. Moreover, you will be paid for travel costs during the follow-up days. During the time you are admitted in the ward, you will be provided with food from the hospital cafeteria and at discharge you will be given an insecticide-treated bed net. When participating in this study, there is a possibility of discomfort to your child during examination and frequent blood sampling. Also in participating in this investigation there is a possibility of increased nausea and vomiting. We will try to reduce the possibility of discomfort, and in case of any problem your child will be provided with appropriate medical care without any cost. The sponsor will have an insurance policy which will be in place prior to the start of the trial. Where is the study run from? 1. Centre National de recherche et de Formation sur le paludisme (CNRFP), Burkina Faso. 2. NIMR, Dar Es Salaam, Tanzania. 3. NIMR Korogwe, Korogwe, Tanzania. 4. Ifakara Health Institute, Bagamoyo, Tanzania. 5. KEMRI, Nairobi, Kenya. When is the study starting and how long is it expected to run for? October 2010 to October 2013 Who is funding the study? Drugs for Neglected Diseases initiative (DNDi) (Switzerland) Who is the main contact? Dr Sodiomon Bienvenu Sirima Centre National de recherche et de Formation sur le paludisme (CNRFP), Burkina Faso

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