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Malaria clinical trials

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NCT ID: NCT01728701 Completed - Malaria Clinical Trials

Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis

Start date: September 2012
Phase: Phase 1
Study type: Interventional

The purpose of the study is to determine the safety and tolerability of ID administration of PfSPZ Challenge to volunteers taking chloroquine chemoprophylaxis (an approach called PfSPZ-CVac).

NCT ID: NCT01722734 Completed - Malaria Clinical Trials

Preserving ACTs - Text Reminders to Increase Adherence to ACT Treatment

PACT
Start date: June 2011
Phase: N/A
Study type: Interventional

A randomized controlled trial was conducted to assess the effectiveness of text reminders sent to ACT users through an automated text messaging system short-message-system. Study hypothesis: text message reminders increase adherence

NCT ID: NCT01717885 Completed - HIV Clinical Trials

Antimalarial Pharmacology in Children and Pregnant Women in Uganda

Start date: August 2012
Phase: N/A
Study type: Observational

The burden of malaria is greatest in children and pregnant women in sub-Saharan Africa. Malaria is one of the most important infectious diseases in the world. Uganda reports among the highest transmission intensities in the world. Children and pregnant women are the most vulnerable populations. HIV is also reported at high rates for these populations. If malaria and HIV require treatment at the same time, there is a high risk for drug-drug interactions. This study will: 1. Determine if the use of anti-HIV medications including lopinavir/ritonavir (LPV/r), nevirapine (NVP) and efavirenz (EFV) will affect the pharmacokinetic (PK) exposure of antimalarial medications (specifically artemether-lumefantrine, AL) during the treatment for uncomplicated malaria in HIV-infected children and pregnant women, and 2. Evaluate the impact of age and pregnancy on the PK exposure of AL.

NCT ID: NCT01716260 Completed - Vivax Malaria Clinical Trials

Safety and Efficacy of Chloroquine and Primaquine for Vivax Malaria in Bhutan

Start date: January 2013
Phase: N/A
Study type: Observational

This research is intended to study the efficacy of chloroquine (CQ) and primaquine (PQ) for Plasmodium vivax (P.vivax) infection, and also to study the recurrence rate among patients with P.vivax malaria on standard doses of CQ and PQ. For this study, PQ will be withheld for 28 days so as to study the efficacy of CQ alone. This study will assess whether CQ is still effective against P.vivax or whether there are resistant P.vivax strains in Bhutan.

NCT ID: NCT01713621 Completed - Malaria Clinical Trials

OZ439 PhIIa Study in Plasmodium Falciparum: Extended Observation

Start date: March 2013
Phase: Phase 2
Study type: Interventional

This study aims to investigate the concentration dependent effects of OZ439 on the clearance of P. falciparum parasites in patients, specifically the determination of an in-vivo minimum inhibitory concentration (MIC) of OZ439. Characterisation of PK-PD (Pharmacokinetic-Pharmacodynamic) relationships is essential for rational evidence based dosing. The adaptive investigation of a range of doses will provide the best chance of accurate PK-PD characterisation, allowing the observation of Plasmodium falciparum growth dynamics and the subsequent identification of MIC and MPC (minimum parasiticidal concentration). Additionally the tolerability and pharmacokinetics of OZ439 will be confirmed. The PK/PD relationship between OZ439 exposure and subsequent effects on parasitaemia will be investigated.

NCT ID: NCT01713608 Completed - Malaria Clinical Trials

A Dose-escalation Study to Investigate Safety and Toleration of OZ439

Start date: November 2012
Phase: Phase 1
Study type: Interventional

A randomised, placebo-controlled, dose-escalation study to investigate safety and toleration of OZ439 OD for 3 days to healthy male and female volunteers. The study aims: - To determine the safety and tolerability of ascending doses of OZ439 OD for three days. - To assess pharmacokinetic parameters of ascending doses of OZ439 given OD. - To identify the maximum tolerated dose of OZ439 administered.

NCT ID: NCT01713517 Recruiting - Malaria, Falciparum Clinical Trials

Impact of Insecticide Resistance on Vector Control

Start date: April 2011
Phase: Phase 4
Study type: Interventional

The purpose of the study is to determine whether long lasting insecticidal nets and indoor residual insecticide spraying, alone or in combination, are effective for controlling insecticide resistant anopheles mosquitoes for malaria prevention.

NCT ID: NCT01708876 Completed - Clinical trials for Uncomplicated Plasmodium Knowlesi Malaria

P. Knowlesi Trial of Artesunate-mefloquine Versus Chloroquine

ACT KNOW
Start date: October 2012
Phase: Phase 3
Study type: Interventional

Preliminary studies have supported the background efficacy of local standard anti-malarial medications in the treatment of uncomplicated knowlesi malaria, however this has not been tested systematically and there are no current WHO treatment guidelines for this infection. There are both health cost benefits to a more rapidly acting agent, and due to difficulties with microscopic identification there may be more effective treatment for all malaria species if an aligned treatment guideline could be supported. In addition, no therapeutic efficacy monitoring of current first line anti-malarials used for the treatment of P. vivax malaria have been conducted in Malaysia. The investigators aim to test whether the fixed combination of artesunate-mefloquine is superior to chloroquine in order to define the optimal treatment for both uncomplicated P. knowlesi and P. vivax infection in both adults and children in this region.

NCT ID: NCT01707199 Completed - Clinical trials for Uncomplicated P. Falciparum Malaria

SPK Study in Afghanistan

Start date: October 2012
Phase: N/A
Study type: Interventional

In Afghanistan, studies over the past 15 years have shown a high degree of Plasmodium falciparum resistance to chloroquine. In 2003 the high failure rate of chloroquine against falciparum malaria led the national malaria treatment programme to switch its recommended first line drug treatment for uncomplicated Plasmodium falciparum malaria to artemisinin-based combination therapy (ACT) in the form of Artesunate/Sulphadoxine-Pyrimethamine (AS+SP). Second line drug treatment is oral quinine (7 days). For operational reasons, prior to recent studies (manuscript in preparation) there have been no molecular data on P. falciparum SP resistance markers from within the borders of Afghanistan. These studies have revealed early evidence of increasing SP resistance (resistance polymorphisms with double DHFR & triple DHPS mutations). The aim of this study is to conduct a focused, prospective study in Kunar for monitoring of the efficacy of the AS+SP combination in this province, along with molecular studies of isolates from recruited patients.

NCT ID: NCT01704508 Completed - Malaria Clinical Trials

Improving Anti-malarial Treatment Options in Guinea-Bissau - Part A

Start date: November 2012
Phase: Phase 4
Study type: Interventional

Plasmodium falciparum causes malaria and approximately 665 000 deaths each year. chloroquine and sulphadoxine-pyrimethamine resistant P. falciparum are widespread. An artemisinin derivative combined with lumefantrine, amodiaquine or piperaquine is therefore recommended for the treatment of malaria in Africa. However, artemisinin resistance appears to be developing and resistance/tolerance to amodiaquine and lumefantrine exists. We are presently conducting a study in Guinea-Bissau. Preliminary data indicates that the effectiveness and availability of artemether-lumefantrine (AL), the 1st line drug, is poor. Consequently there is a need for another treatment option. Dihydroartemisinin-piperaquine (DP) has been shown to be efficacious and well tolerated in several African countries and is therefore such an option. A clinical trial comparing the safety and efficacy of artemether-lumefantrine and dihydroartemisinin-piperaquine is therefore needed. Parents to children seeking Bandim Health Centre (CSB) with symptoms compatible with malaria will be informed of the study. If accepting and the child fulfil the inclusion criteria, the child will be randomised to treatment with either AL or DP. The treatment will be given supervised at the health centre in the morning and the evening on day 0, day 1, and day 2. At each visit and in the morning on day 3, the child will be examined, the mother asked for any symptoms and signs of side-effects, the temperature measured. Furthermore, a blood sample will be taken for examination of malaria parasites. On day 0 samples for measurement of antimalarial drugs and for genotyping of the parasites will be taken on filterpaper. In a subgroup of 50 children a blood sample for in vitro culturing and for analysis of the number of leucocytes will also be taken. After having finished the treatment the children will be followed on day 7 and then once a week until day 42. At each visit the condition of the child will be examined and a bloodsample taken for examination of parasites in the blood. Furthermore, a filterpaper bloodsample will be collected for measurement of the drug concentration of if the child has recrudescence for genotyping of the parasites. On day 0, 3 and 42 the haemoglobin level will be examined. The result of the two treatments will be evaluated by comparing the number of children with recurrent parasitaemia, both corrected and uncorrected (recrudescence vs. reinfections). This will be presented as adequate clinical and parasitological response rates PCR-corrected and PCR-uncorrected. Furthermore, the chance in haemoglobin level from day 0 till day 3 and till day 42 will be compared. The concentration of the antimalarial drug in the blood samples taken at the visit before the re-parasitaemia will be capered to the concentrations in children without re-parasitaemia. Assuming a 20% loss to follow up a total of 346 children should be included. For the children included, health care and medications at Bandim Health Centre will be free during the study period but no other gifts or payments will be made. Results will be presented to the staff at the Bandim health centre and the ministry of Health and will be published in an international peer reviewed journal.