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Malaria clinical trials

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NCT ID: NCT03431714 Completed - Clinical trials for Uncomplicated Falciparum Malaria

Efficacy and Safety of ASAQ and PD for the Treatment of Uncomplicated Falciparum Malaria in Mainland Tanzania

GF-TES-2017
Start date: July 14, 2017
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT03431168 Completed - HIV Clinical Trials

A Novel Regimen to Prevent Malaria and STI in Pregnant Women With HIV

PREMISE
Start date: March 7, 2018
Phase: Phase 2
Study type: Interventional

More than 3 billion people worldwide are at risk of acquiring malaria and pregnant women living with HIV in Africa are at particular risk. An effective prophylaxis regimen capable of preventing malaria and other common perinatal infections would have great potential to improve adverse birth outcomes. The purpose of this randomized controlled trial is to evaluate a new combination prophylaxis regimen in pregnant women with HIV in Cameroon to determine its efficacy and safety.

NCT ID: NCT03420053 Completed - Malaria Clinical Trials

Study to Evaluate Safety, Immunogenicity and Efficacy of PfSPZ Vaccine in HIV Negative and HIV Positive Tanzanian Adults

Start date: February 7, 2018
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled trial to evaluate safety and tolerability of PfSPZ Vaccine administered as five doses of 9.0x10^5 PfSPZ or normal saline at 0, +2, +4, +6 and +28 days to healthy HIV negative adult volunteers and healthy HIV positive volunteers in Tanzania.

NCT ID: NCT03399318 Completed - Malaria Clinical Trials

Aggressive Antipyretics for Fever Reduction in CNS Malaria

Start date: January 7, 2019
Phase: Phase 2
Study type: Interventional

The study will examine whether prophylactic and scheduled treatment with acetaminophen and ibuprofen can decrease the maximum temperature experienced during the acute illness in children with CNS malaria.

NCT ID: NCT03394976 Withdrawn - Clinical trials for Human African Trypanosomiasis

Prospective Evaluation of an RDT to Screen for Gambiense HAT and Diagnose P. Falciparum Malaria

Start date: January 31, 2022
Phase:
Study type: Observational

A prototype rapid diagnostic test (RDT) to simultaneously screen for gambiense human African trypanosomiasis (HAT) and diagnose P. falciparum malaria (the "HAT/malaria combo") has recently been developed. The performance of this prototype has been evaluated in a retrospective study that showed that its diagnostic performance for HAT and malaria was equivalent to the performance of the SD BIOLINE HAT 2.0 and the SD BIOLINE Malaria Ag P.f tests, respectively. The purpose of this study is to prospectively evaluate the performance of the test in settings where P. falciparum malaria is endemic, and which are either endemic or non-endemic for HAT. This will enable the assessment of the suitability of the HAT/malaria combo RDT as a diagnostic test for malaria, and a screening test for HAT in pre-elimination and post-elimination contexts, respectively.

NCT ID: NCT03387631 Completed - Clinical trials for Uncomplicated Malaria

Efficacy And Safety Of AL For The Treatment Of Uncomplicated Falciparum Malaria In Mainland Tanzania

TES2016
Start date: April 2016
Phase: N/A
Study type: Observational [Patient Registry]

Following the development of drug resistance to antimalarial first line treatment of uncomplicated malaria with SP by P.falciparum in mainland Tanzania, the Ministry of Health - Tanzania, introduced ACTs with AL as first line treatment for uncomplicated falciparum malaria in 2006. In the advent of wide scale deployment of ACT together with strengthened vector control with LLIN in mainland Tanzania, there is a trend of shrinking the burden of malaria. The decline of outpatient malaria cases in recent years and declining entomological inoculation rates (EIR) that are currently being recorded in most areas that were before considered to be holo/hyper-endemic to malaria transmission is another indicator of the shift in the epidemiology of malaria transmission in Tanzania. This current shift provides a new and yet critical challenge with regards to assessment and monitoring of the efficacy of the first-line treatment specifically considering that artemisinin resistance has been confirmed in the Greater Mekong sub-region. The aim of the study was to set up a system for country wide representative surveillance to obtain data of the safety and efficacy of AL following countrywide use of ACTs for treatment of uncomplicated malaria in Tanzania. The study was conducted in the framework of the existing NMCP sentinel sites that are ecological representative for malaria endemicity in Tanzania Objective: To assess the efficacy and safety of artemether-lumefantrine, artesunate-amodiaquine and dihydroartemisinin-piperaquine for the treatment of uncomplicated falciparum malaria in Tanzania. Methods: The study was conducted in eight sentinel sites of NMCP (Kyela, Mkuzi, Kibaha, Ujiji, Nagaga, Chamwino, Igombe and Mlimba) in mainland Tanzania. Four sentinel sites (Mlimba, Mkuzi, Kibaha, and Ujiji) were covered in 2016 and the rest will be involved in the second round to be undertaken in 2017. Patients were treated with AL for 3 days and the study was conducted from April to Sept 2016. The results of this study will assist the Ministry of Health to monitor the efficacy and safety of the ACTs in Tanzania, provide baseline data on parasite clearance time and for assessing the current national treatment guidelines for uncomplicated falciparum malaria.

NCT ID: NCT03384498 Recruiting - Clinical trials for Plasmodium Falciparum and Plasmodium Vivax

Malaria Genetic Surveillance

Start date: October 2016
Phase:
Study type: Observational

This study is to determine the prevalence and geographical distribution of antimalarial drug resistance-linked genetic mutations in clinical P. falciparum and/or P.Vivax infection in the Greater Mekong Subregion

NCT ID: NCT03384472 Completed - Malaria Clinical Trials

Malaria Genetic Surveillance in Cambodia

Start date: June 1, 2016
Phase:
Study type: Observational

This study is to determine the prevalence and geographical distribution of antimalarial drug resistance-linked genetic mutations in clinical P. falciparum infections in Cambodia

NCT ID: NCT03377296 Completed - Malaria, Vivax Clinical Trials

Study of Controlled Human Plasmodium Vivax Infection

VAC068
Start date: March 3, 2018
Phase: N/A
Study type: Interventional

This is a sporozoite-challenge clinical study with the primary aim of assessing the safety and feasibility of controlled human P. vivax malaria infection in two healthy volunteers. The investigators will also assess the growth of and the immune response to P. vivax infection, and assess the induction of sexual gametocytaemia post-CHMI via the natural route of malaria infection (mosquito bite). A secondary objective is to develop a blood inoculum of P. vivax-infected blood for future testing of candidate vaccines.

NCT ID: NCT03376217 Completed - Clinical trials for Malaria in Pregnancy

Assessing the Effectiveness of Community Delivery of Intermittent Preventive Treatment in Pregnancy (IPTp) in Malawi

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

The overall aim of the study is to learn whether utilization of Health Surveillance Assistants (HSAs) for delivery of intermittent preventive treatment of malaria in pregnant women (IPTp) can increase coverage of three or more IPTp doses compared to IPTp delivery only at antenatal clinics (ANC), while at the same time improve or maintain ANC attendance. This will be a cluster randomized trial, including a total of 20 health facilities (HF) which will be randomly assigned to either the intervention (10) or non-intervention group (10); all HSAs affiliated with a HF will be in the same group.