View clinical trials related to Uncomplicated Falciparum Malaria.
Filter by:Single-center phase II/III clinical investigation of the pharmacokinetics and pharmacodynamics of artemether-lumefantrine and dihydroartemisinin-piperaquine for gametocyte clearance and post-treatment chemoprotection in Zambian children with uncomplicated falciparum malaria.
The World Health Organization recommends regular surveillance of antimalarial efficacy to monitor the performance of different drugs. The Tanzanian National Malaria Control Programme (NMCP) in collaboration with its partners have been implementing therapeutic efficacy studies (TES) to monitor the performance of different antimalarials in the country. Most of the studies conducted in recent years focused on artemether-lumefantrine which is the first line antimalarial for the treatment of uncomplicated malaria in Mainland Tanzania. However, data on the performance of other artemisinin based combination therapy (ACTs) is urgently needed to support timely review and changes of treatment guidelines in case of drug resistance to current regimen. This study was undertaken in the same NMCP framework to assess the efficacy and safety of alternative ACTs used or with potential use in Tanzania. The study assessed the efficacy and safety of artesunate-amodiaquine (ASAQ) and dihydroartemisinin-piperaquine (DP) for the treatment of uncomplicated malaria in Tanzania. The study was undertaken at two NMCP sentinel sites of Kibaha and Ujiji from July to December 2017.
Emerging resistance to artemisinins and their partner drugs severely threatens the treatment of falciparum malaria in Myanmar with artemisinin combination therapies. To inform drug policy, it is crucial to evaluate alternative antimalarial treatments. The investigators here propose a randomized clinical trial comparing parasite clearance parameters and efficacy of 3 days arterolane-piperaquine with standard treatment with 3 days dihydroartemisinin (DHA)-piperaquine in adult patients with uncomplicated falciparum malaria in Myanmar stratified for the presence of "K13" mutation in the infecting parasite strains.
Title: Efficacy and safety of artesunate-amodiaquine combined with methylene blue for falciparum malaria treatment in African children: randomised controlled trial. Design: Mono-centre, two arms, open randomized controlled study in children with uncomplicated falciparum malaria in Burkina Faso. Phase: Phase II. Objectives: The primary objective of this trial is to study the efficacy and safety of the triple therapy artesunate (AS) - amodiaquine (AQ) - methylene blue (MB) given over three days in young children with uncomplicated falciparum malaria in Burkina Faso compared to the local standard three days artemisinin-based combination therapy (ACT) AS-AQ regimen. Population: Children aged 6-59 months with uncomplicated falciparum malaria from Nouna Hospital in north-western Burkina Faso. Sample size: 180 patients (90 per study arm).
This study is an evaluation of the benefit of adding artesunate to existing first and second line antimalarial therapies in Pakistan. A placebo controlled trial was carried out to assess two potential benefits of Artesunate Combination Therapy (ACT): efficacy and potential for transmission reduction.
It has now been demonstrated clearly that in Western Cambodia parasitological responses to artesunate and artemether containing treatment regimens for uncomplicated falciparum malaria are slower than elsewhere in the world. Median parasite clearance time (PCT) in patients treated with artesunate 4 mg/kg/day was 78 hours and with 2 mg/kg/day 82 hours, compared to 54 and 48 hours, respectively, in Western Thailand; at 72hours peripheral blood parasitaemia was still detectable in 55% of patients in Western Cambodia, compared to 7.5% in Western Thailand. Although occasional poor responses to artesunate have been described previously the current reports suggest a consistent problem. These antimalarials are central to current treatment strategies, and so spread of parasites with reduced artemisinin susceptibility outside this area would be a disaster. A recent consensus meeting Pnomh Penh agreed that this should indeed be termed resistance, and represented a major threat to malaria control. Radical containment measures would be needed. This study aims to address whether a semi-synthetic or fully synthetic peroxide antimalarial would be more effective than artesunate and could therefore be used in Cambodia as part of the elimination strategy. Artemisone is a semisynthetic derivative of dihydroartemisinin, which importantly changes its tertiary structure. This drug has also shown promising efficacy for the treatment of uncomplicated falciparum malaria in phase II trials in Thailand and seems to be at least as efficacious as artesunate. No significant toxicity has been reported for artemisone and it is very well tolerated. If sensitivity for artemisone has remained intact in Western Cambodia, this will have important implications for the strategies available for containment of the threatening problem of artesunate resistance in Western Cambodia. It will also have important implications for further development of these drugs for the use in artemisinin combination therapies (ACTs).
Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region. Artemisinin-based combination therapy is now the recommended treatment for uncomplicated falciparum malaria. The success of this policy change in practice will depend on the efficacy of the components of the combination used, the population coverage achieved, high levels of adherence to treatment, low cost of the drugs, and preferably the drugs in a combination treatment should be formulated in a single tablet, to prevent one drug being taken without the partner drug. Until recently there were only two artemisinin-based fixed combinations available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former has international registration. More fixed combinations are needed urgently.
Malaria is a major public health problem in many provinces of Afghanistan the failure rate of chloroquine (CQ) and amodiaquine (AQ) treated Plasmodium falciparum(Pf) malaria has risen to more than 60% overall and as high as 90% in Jalalabad. CQ remains fully effective against P vivax, and sulphadoxine-pyrimethamine (SP) remains effective against P falciparum (10-15% of cases fail to cure). The current malaria treatment protocol still continuing CQ for P.vivax and adopted Artmisinine based combination therapy (ACT) for treating (Pf) malaria, as most than 50% malaria has being diagnosed clinically, so due to this and other operational reasons the protocol needs to be simplified. By comparing 56 day PCR corrected cure rate of DHA-PPQ with the standard treatment regimen as primary objective and comparing the safety, gametocytecidal effect and parasite clearance time as secondary objectives, our study titled: Randomized, Open Label, controlled, non-inferiority clinical trial for comparison of Efficacy & safety, will provide scientific evidence to lead the simplification and improvement of the standard malaria treatment regimen in Afghanistan; to adopt a policy of treating both vivax and falciparum malaria with the same drug regimen. With a significance level (α) = 0.05 and a power=80%, the calculated sample size is 274 per study arm. Therefore about1100 patients (274 per study-arm: 548 patients with falciaprum malaria and 548 patients with vivax malaria) will be recruited in Malaria reference Centers (MRCs) of three malaria endemic provinces (Nangarhar in the east, Thakhar in the north-east and Faryab in the north-west of country) after signing written inform consent form, according the inclusion and exclusion criteria and will be treated as out patients by giving the randomized drug dose under observation of study team and followed-up daily for 3 days (as treatment course of either arm is once daily dose for three days) and after than weekly up to day 56. and the study is planed to conducted in 3 provinces of Afghanistan for approximately 2 years. Patients will be assessed clinically as well necessary laboratory tests will be performed and all the bio-medical findings will be recorded in special patient case record form, the electronic form of which will be broth to Trop. Med of Mahidol University for final analysis. The patients will be receiving the reasonable transportation cost for follow-up visits as well as one bed-net at the end of enrollment.
The purpose of this study is to investigate the efficacy of azithromycin combination therapy with artesunate for the treatment of uncomplicated falciparum malaria in Bangladesh.