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Malaria, Falciparum clinical trials

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NCT ID: NCT02612545 Completed - Clinical trials for Acute Falciparum Malaria

Efficacy, Safety, and Tolerability of Dihydroartemisinin-piperaquine + Mefloquine Compared to Dihydroartemisinin-piperaquine or Artesunate-mefloquine in Patients With Uncomplicated Falciparum Malaria in Cambodia

Start date: November 20, 2015
Phase: Phase 1
Study type: Interventional

Background: Malaria is an illness caused by a parasite that enters people s bodies when a mosquito bites them. It can cause fevers, headaches, body aches, and weakness. If not treated, it can make some people very ill. Malaria can be cured. A mix of 2 drugs that has worked well in the past is not working as well in some parts of Cambodia. Researchers want to see if a mix of 3 drugs works better and is safe. Objectives: To see if a 3-drug mix can be used to treat malaria in areas where a 2-drug mix is less effective. Eligibility: People aged 2 65 years with mild malaria in Pursat, Preah Vihear, and Ratanakiri Provinces in Cambodia. Design: Participants will be screened with medical history, physical exam, urine and blood tests, and an electrocardiogram (ECG). For this, electrodes will be placed on their skin to check their heartbeat. Participants will spend about 5 nights in the hospital. They will have physical exams and will complete symptom questionnaires daily. They will give blood periodically throughout their stay. For this, a thin plastic tube is placed in an arm vein for the first day, and blood draws using a needle are done after that. Participants will get either a 2-drug mix or a 3-drug mix for 3 days. They will have 2 ECGs each day of receiving the drugs. Participants will have follow-up visits once a week over 5 weeks. At these visits, they will have a physical exam and have blood taken. If they have any signs of malaria, they will be re-treated. The study will last up to 42 days.

NCT ID: NCT02604966 Recruiting - Clinical trials for Drug Resistant Malaria Due to Plasmodium Falciparum

P. Falciparum Resistance to Artemisinin in Vietnam

Start date: April 2015
Phase: Phase 4
Study type: Interventional

At the end of 2012, the Institute of Tropical Medicine in collaboration with National Institute of Malariology Parasitology and Entomology (NIMPE) conducted a study in Quang Nam province, central Vietnam, to assess the efficacy of the national DHA-PPQ regimen for the treatment of uncomplicated P. falciparum malaria infections, both in adults and in children. Results showed that about 30% of the study participants were parasitaemic at day 3. Parasite clearance rate was estimated at 6.2h, which was comparable to figures from Pailin, Cambodia, where artemisinin resistance were previously reported . However, results from this study have to be interpreted bearing in mind that: (i) the age-based drug dosing scheme used has been criticized as insufficient to clear parasites and (ii) DHA-PPQ drugs used (Artecan™), Vietnam, are not produced under Good Manufacturing Practices (GMPs). However, those results prompted the NMCP and WHO to declare Quang Nam, Binh Phuoc, Dak Nong, and Gia Lai provinces as a "Tier I area" (credible evidence of artemisinin resistance) in May 2013. By end of 2014 a fifth province, Khanh Hoa, was declared Tier I (Dr Hong, Personal Communication). Except for the south-eastern province of Binh Phuoc, artemisinin resistance has never been confirmed with an artemisinin based monotherapy in Central Vietnam. Therefore, in order to confirm artemisinin resistance in Central Vietnam , a study with oral artemisinin-based monotherapy, using WHO prequalified AS and DHA-PPQ and recommended dosing scheme of 4mg/kg/day for AS and DHA, is needed. In the arm where study participants are treated with 3 days of AS monotherapy, treatment will be followed by an additional 3-day course of DHA-PPQ to effectively clear all parasites. The aim of the present study is to confirm artemisinin resistance in Central Vietnam by assessing P. falciparum clearance time and rate after AS monotherapy (WHO recommended dosage). The investigators will conduct a two-arm open label, randomized study, with one arm receiving AS monotherapy for 3 days + 3-day of DHA-PPQ, and a second arm receiving 3 days of DHA-PPQ.

NCT ID: NCT02600767 Completed - Malaria Clinical Trials

Artemether-lumefantrine for Treatment of P. Falciparum Malaria in Brazil

Start date: December 2015
Phase: N/A
Study type: Interventional

This is an in vivo evaluation of drug efficacy performed in Cruzeiro do Sul, in the state of Acre, Brazil. A total of 81 participants ≥5 years old with parasitological confirmation of P. falciparum monoinfection will be treated under supervision with artemether-lumefantrine for three days, with doses according to the Brazilian guidelines for malaria control. The clinical and parasitological parameters will be monitored for a 28-day follow-up period to evaluate the efficacy of the combination therapy. A blood sample will be collected on filter paper on the first day and on the day of suspected failure to try to differentiate the parasite genotypes using techniques based on polymerase chain reactions. The results of this efficacy evaluation on the drug combination will help the Brazilian Ministry of Health to evaluate the national policy for treatment of malaria caused by P. falciparum.

NCT ID: NCT02543086 Terminated - Clinical trials for Plasmodium Falciparum Malaria

Effectiveness of KAE609 in Reducing Asexual & Sexual Blood-stage P.Falciparum Infection & Infectivity to Mosquitos

Start date: July 2015
Phase: Phase 1
Study type: Interventional

This is a single-center open label study conducted in multiple sequential cohorts using Induced Blood Stage Malaria infection in healthy volunteers to characterize the effectiveness of KAE609 against sexual and asexual blood stage forms of Plasmodium falciparum. This study is divided in 2 parts (Part A and part B). A total of 8 healthy volunteers per cohort will be enrolled. Based on the results of Part A, Part B will be undertaken to evaluate the effect of KAE609 following pretreatment with Piperaquine on sexual stage/gametocytemia and its activity as an inhibitor of onward transmission to mosquito vectors using experimental mosquito feeding assays.

NCT ID: NCT02497612 Terminated - Clinical trials for Plasmodium Falciparum Infection

To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

FALCI
Start date: July 25, 2015
Phase: Phase 2
Study type: Interventional

Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children. Secondary Objectives: - To evaluate the efficacy of OZ439/FQ: - To determine the incidence of recrudescence and re-infection. - To determine the time to relief of fever and parasite clearance. - To evaluate the safety and tolerability of OZ439/FQ in adults and children. - To characterize the pharmacokinetics of OZ439 in plasma, FQ and its active metabolite SSR97213 in blood. - To determine the blood/plasma ratio for FQ and SSR97213 in some participants at limited time points in selected sites.

NCT ID: NCT02461186 Withdrawn - Clinical trials for Uncomplicated Falciparum Malaria

Arterolane-PQP Versus DHA-PQP in Uncomplicated Falciparum Malaria in Eastern Myanmar

Start date: June 2015
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT02458092 Completed - Malaria Clinical Trials

Evaluate the Safety and Efficacy of Plasmodium Falciparum Malaria Protein 010 (FMP010) Administered With Adjuvant AS01B

Start date: April 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether an investigational malaria vaccine is safe and induces an immune response against malaria when tested in adults living in the United States.

NCT ID: NCT02453308 Completed - Malaria, Falciparum Clinical Trials

A Study by the Tracking Resistance to Artemisinin Collaboration (TRAC)

TRACII
Start date: August 2015
Phase: Phase 2/Phase 3
Study type: Interventional

This study is an open-label randomised trial comparing standard ACT treatment with matching triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1 site in Africa. There are 2 arm study groups that have 2 treatment arms each. Study group A: A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days. Study group B: B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days. Study group C: C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days. According to the WHO guideline, all patients except for children under the age of 1 year or a weight below 10 kilograms will also be treated with a single dose of low dose primaquine.

NCT ID: NCT02448745 Completed - Anemia Clinical Trials

Liberia Insecticide Treated Durable Wall Linings Study: Protocol for a Cluster Randomised Trial (DL)

Start date: March 1, 2014
Phase: N/A
Study type: Interventional

A cluster-randomized control trial will study the effect of insecticide-treated wall lining on malaria transmission in Bomi County, Liberia. Half of the villages enrolled in the study will receive insecticide-treated wall lining covering their walls and ceilings in addition to long-lasting insecticidal nets, while the other half will be protected by existing long-lasting insecticidal nets.

NCT ID: NCT02434952 Completed - Malaria, Falciparum Clinical Trials

Safety and Tolerability of Low Dose Primaquine

Start date: October 2014
Phase: Phase 4
Study type: Interventional

In Cambodia, falciparum is becoming more difficult to treat because drugs are becoming less effective. The investigators can help to try to prevent the spread of this resistant malaria by adding a drug that will make it more difficult for the mosquito to drink up the malaria in people's blood. If the mosquito cannot drink up the malaria, then the malaria cannot develop in the mosquito so it will not be able to inject malaria back into people when it bites. The drug the investigators will use is called primaquine. Primaquine commonly causes the red cells in the blood to break apart if they are weak. Red cells need enzymes to work properly and weak red cells have low amounts of an enzyme called glucose 6 phosphate dehydrogenase (G6PD). The investigators want to know if treating malaria with primaquine will be safe for the red cells. To do this study, the investigators need to know if a subject has low G6PD or not.