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P. Falciparum Malaria clinical trials

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NCT ID: NCT04877626 Completed - Clinical trials for P. Falciparum Malaria

Assessment of the Therapeutic Efficacy and Tolerability of the Artesunate/Amodiaquina Combination and Artemether/Lumefantrine Combination, Treatment of Uncomplicated P. Falciparum Malaria in the Department of Chocó (Colombia)

UNAL MALARIA
Start date: September 2008
Phase: Phase 4
Study type: Interventional

Background: Malaria by P falciparum is a public health problem in more than 100 municipalities of Colombia. The country is using the artemether+lumefantrine (AM+L) fixed combination for uncomplicated P falciparum malaria but it is ideal to have different types of formulations with similar efficacy that may be used in diverse circumstances. One alternative of treatment is using preparations containing artesunate and amodiaquine (AS+AQ) in fixed combination, which can be given in a simpler dosing regimen. In order to assess the efficacy of that combination in an area with suspected risk of resistance to amodiaquine an open controlled clinical trial was carried out in Colombia. Methods: The study was done in Choco, a high endemic area for malaria by P falciparum, from August 2008 and September 2009. Patients diagnosed with uncomplicated malaria (n=210) malaria were randomized in two arms, one receiving AS+AQ and the other AM+L. The main clinical results was parasitological cure, i.e. a negative blood smears, that was assessed, for both groups, at days 1, 2, 3, 7, 14, 21 and 28 after the onset of treatment. Results: There were no losses at follow up. The mean age of the enrolled study subjects was of 37.5 years without differences between study arms. Both therapies were very well tolerated in general. The efficacy for AS+AQ was 100%, and 99% for AM+L (p>0.1). In average, patients in the AS+AQ arm became negative for P falciparum parasites and gametocytes earlier than those at the AM+L arm. Blood smears became negative after one day of treatment with AS+AQ and after two days of treatment with AM+L. Gametocytes disappeared after 2 days of treatment in the AS+AQ arm compared to 4 days in the AM+L arm. Conclusions: In this study, the efficacy of the AS+AQ combination was similar to that of the AM+L. This finding do not support the hypothesis that there is a level of resistance to amodiaquine that prevents its use combined with artemisinin derived.

NCT ID: NCT02427360 Completed - Clinical trials for P. Falciparum Malaria

Evaluating the Efficacy of Artesunate-mefloquine and the Relative Roles of Resistance Genetic Markers

MMA
Start date: May 2015
Phase:
Study type: Observational

This is a retrospective non randomized cohort to evaluate efficacy of MAS3 on patients with uncomplicated P. falciparum malaria or mixed infection (P. falciparum + a non-falciparum species). The review of patients' records and blood samples will be performed for patients treated at the clinics of Shoklo Malaria Research Unit from the period of January 2003 to December 2013.

NCT ID: NCT01082705 Completed - Clinical trials for P. Falciparum Malaria

Assessing the Efficacy of Artemisinin Combination Therapies for Treatment of Uncomplicated Malaria Infection in Children

Start date: April 2010
Phase: Phase 3
Study type: Interventional

Following the rapid development of significant drug resistance to both chloroquine and sulfadoxine-pyrimethamine (the first line therapy in Tanzania from 2001 -2006), artemether- lumefantrine (Coartem or AL) was adopted as first line therapy in Tanzania in 2006. Now that this drug has been widely used for some time, the investigators propose to conduct an antimalarial efficacy trial to monitor the effectiveness of this therapy, to determine if this drug remains efficacious, or if significant resistance has emerged, in which case a new antimalarial strategy will need to be contemplated. The investigators hypothesize that the efficacy of Artemether-lumefantrine remains high, and that the other artemisinin combination therapies will be equally efficacious. Children 6-59 months of age with symptomatic malaria will be randomly assigned to be treated with either artemether + lumefantrine (Coartem) or dihydroartemisinin-piperaquine (Duo-Cotecxin or Artekin). Clinical, parasitologic, and hematologic parameters will be monitored over a 42-day follow-up period and will be used to evaluate drug efficacy.

NCT ID: NCT00757887 Completed - Clinical trials for P. Falciparum Malaria

Re-exposure of EHMI-8 Human Volunteers to Live Malaria Sporozoites

Start date: October 2009
Phase: N/A
Study type: Interventional

In the EHMI-8 study (CMO 2006/207) the investigators induced sterile protection against P. falciparum challenge in healthy Dutch volunteers by repeated exposure to infected mosquitoes whilst under chloroquine prophylaxis. The surprisingly efficient induction of protection in this study strongly supports the development of whole parasite vaccines and is therefore an important finding to malaria vaccine development. In this study (EHMI8B) the investigators would like to explore the longevity of the protective immune response and simultaneously further characterise immune mechanisms responsible for protection by re-exposing EHMI-8 volunteers to infected mosquito bites.