| - candidate number | 2388 |
| - NTR Number | NTR864 |
| - ISRCTN | ISRCTN36463274 |
| - Date ISRCTN created | 1-feb-2007 |
| - date ISRCTN requested | 28-jan-2007 |
| - Date Registered NTR | 3-jan-2007 |
| - Secondary IDs | N/A |
| - Public Title | A randomized trail to asses the efficacy of Arthemeter Lumifantrine and Dihydroartemisinin -piperquine in the treatment of uncomplicated malaria and its effects on transmission in Kenya |
| - Scientific Title | A randomized trail to asses the efficacy of Arthemeter Lumifantrine and Dihydroartemisinin -piperquine in the treatment of uncomplicated malaria and its effects on transmission in Kenya |
| - ACRONYM | N/A |
| - hypothesis | Find the most effective ACT treatment for uncomplicated falicparum malaria and the best treatment in respect to the transmission of the dissease |
| - Healt Condition(s) or Problem(s) studied | Malaria, Plasmodium falciparum infection |
| - Inclusion criteria | 1. Age six to 12 years; 2. Resident in research area and able to comlete follow up; 3. Temperature higher than 37.5 degrees but lower than 39.5 degrees or history of fever in last 24 hours; 4. Understanding the procedures of the study by parents or guardian (informed consent); 5. Diagnosed with uncomplicated malaria. P. falciparum only; 6. Parasitaemia 100-100.000 parasites/ul |
| - Exclusion criteria | 1. General danger signs, severe malaria or severe anaemia; 2. Severe malnutrition; 3. Presence of diseases other than malaria causing febrile conditions; 4. Unwilling to participate and sign informed consent form. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-mrt-2007 |
| - planned closingdate | 1-mrt-2008 |
| - Target number of participants | 150 |
| - Interventions | Two groups of 75 children meeting the inclusion critera will be enroled to the study and randomized to a treatment with either Lumifantrine and Athemeter or Dihydroartemisinin with Piperaquine. A fingerprick blood sample for parasite detection will be taken from children presenting at the outpatient clinic with symptoms indicating uncomplicated malaria. Name of the child, father and mother, age, weight and clinical symptoms including fever are recorded at a case record form. The blood sample will be used to prepare thick and thin blood smears, and to measure haemoglobin level by using Hemocue. Blood smears will be Giemsa-stained and parasites counted against 200 WBC, with parasite negative results based on screening of 100 microscopic fields. Parasitological data are added to the patient card. Children diagnosed with uncomplicated P. falciparum malaria and meeting all inclusion/exclusion criteria will be enrolled in the drug study after explaining the purpose and procedures of the study and obtaining informed consent from the parent(s) or guardian(s).After enrolment, in the drug study an additional fingerprick blood sample will be taken to store a sample on filter paper for molecular testing by QT-NASBA. All children not included in the study will be referred back to the clinician with their patient cards for further diagnosis and treatment. They will be treated as any other outpatient and receive treatment as required. |
| - Primary outcome | Cured from P. falciparum infection with addequate clinical and parasitological respone as defined by WHO guidlines for clinical trails in malaria research. |
| - Secondary outcome | 1. Difference in cure rate between the different treatments; 2. Effect on transmission stages (gametocytes) of the parasite. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Drs. P. Mens |
| - CONTACT for SCIENTIFIC QUERIES | Drs. P. Mens |
| - Sponsor/Initiator | Royal Tropical Institute (KIT), Bio-Medical Research, Academic Medical Centre (AMC), Devision for Tropical Medicine and AIDS, Kenya Medical Research institute, Centre for Biotechnology research and Development |
| - Funding (Source(s) of Monetary or Material Support) | Royal Tropical Institute, Knowledge and innovation fund, St. Dioraphte |
| - Publications | Mens, P.F., Schoone, G.J., Kager, P.A. & Schallig, H.D.F.H. (2006). Detection and Identification of human Plasmodium species with real-time quantitative nucleic acid sequence based amplification. Malaria Journal 5, 80 Petra Schneider, Gerard Schoone, Henk Schallig , Danielle Verhage ,Denise Telgt, Wijnand Eling, Robert Sauerwein Quantification of Plasmodium falciparum gametocytes in differential stages of development by quantitative nucleic acid sequence-based amplification Molecular & Biochemical Parasitology 137 (2004) 35–41 |
| - Brief summary | Accurate diagnosis followed by proper treatment is essential in the control of malaria. Both aspects are however still huge challenges since cheap and accurate diagnosis is not yet available and emerging resistance against various anti-plasmodials is still on the rise. Therefore, affordable alternative drugs for the treatment of uncomplicated malaria must be evaluated Effective drugs against malaria such as artiminisinin based combination (ACT) therapies are expensive and will only be of real value when they are distributed in combination with good diagnosis. This project focuses on both drug evaluation and evaluation of a novel diagnostic tool for the detection of Plasmodium parasites. The widely used ACT artemether-lumefantrine (Coartem) will be evaluated in a two armed study and compared to the less evaluated but cheaper anti-plasmodial dihydroartemisinin-piperaquine (Artekin). In this study the parasite dynamics will be monitored by quantitative nucleic acid sequence based amplification technology (QT NASBA) for the measurement of the whole parasite load, the gametocyte specific and specific asexual stages. This will not only reveal the efficacy of the drugs but also their impact on gametocyte clearance and therefore their value in reducing transmission. |
| - Main changes (audit trail) | |
| - RECORD | 3-jan-2007 - 7-feb-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl