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90 active trials for Malaria

Clinical Investigation Study to Evaluate the Consistency and Reproducibility of Two Consecutive Mosquito Feeding Assays

The proposed trial design has been developed to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval.

Start: December 2020

Mobile Point of Care Diagnostic Testing for Ebola Virus Disease in DRC

A mobile suitcase laboratory for EBOV point-of-care (POC) detection at Ebola treatment centers was successfully implemented in Guinea during the large Ebola virus disease (EVD) outbreak in West-Africa 2014-2015. It was shown that isothermal amplification (Recombinase Polymerase Amplification (RPA)) could be efficiently used to test suspect EVD cases and local teams were trained in and successfully deployed with this fast method. In the frame of this project we want to train teams in DRC and expand RPA testing capacity to the differentials recommended by the WHO. Existing RPA assays for all parameters will be included into a multistrip for simultaneous use. This will be integrated with a simple biosafe extraction method. Implementing this approach and testing in the ongoing EVD outbreak will provide teams in DRC with response capacity for future EVD outbreaks.

Start: January 2021

Optimizing Benefits While Reducing Risks of Iron in Malaria-endemic Areas

Daily iron (ferrous sulfate, 2 mg/kg/day) or placebo syrup for first four months (112 days) of the 12-month (336-day) study. Children in the immediate iron group will receive iron syrup for the first three months (84 days) and placebo syrup for the fourth month. Children in the delayed iron group will receive placebo syrup for the first month (28 days) and iron syrup for the second, third, and fourth months.

Start: September 2019

Uganda Housing Modification Study

To explore housing modification as a malaria control intervention, and to assess the degree to which it may offer protection in moderate to high malaria endemicity settings, we propose a two-phase study evaluating epidemiological and entomological effectiveness, cost-effectiveness, feasibility, and acceptability of housing modification in Uganda. The first phase will be a pilot implementation assessing the feasibility of candidate housing modification interventions, followed by a cluster randomised control trial of the most effective, scalable, and cost-effective interventions.

Start: January 2021

Baseline Cohort Malaria Morbidity Study

The BLOOMy study is a longitudinal prospective cohort study of healthy children to assess the incidence of clinical malaria over the main transmission season. Participants will undergo baseline clinical and biological assessments then will receive a curative dose of either artesunate or dihydroartemisinin-piperaquine to clear any existing parasitemia. Clearance of parasites will be confirmed 3 weeks later by Polymerase chain reaction (PCR) and only participants with negative PCR will be definitively enrolled for the longitudinal follow up. Both active and passive case detection will be used to ensure that capture of a high proportion of infections in the cohort is achieved. Blood samples for immunological assessments will be obtained at Day 0 of each positive blood smear episode before treatment and at Weeks 4 post treatment. Participants will be followed for a minimum of six months throughout the malaria peak transmission season.

Start: September 2020

Aggressive Antipyretics for Fever Reduction in CNS Malaria

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.

Start: July 2018

Mobilization at the Level of Schools on the Behavioral Change in Favor of the Fight Against Malaria in Mbandjock

The main aim of this study is to determine the effect of awareness campaigns by school children targeting their communities on knowledge, attitudes, and practices in malaria control in the Mbandjock health district. A two-arm, open-label, randomized controlled clinical trial will be adopted with the Mbandjock Health District as the test district and Sa'a Health District as control Health District. This will last from January 2017 to December 2020. The Lot Quality Assurance Sampling (LQAS) method was used. The health area was selected in the ratio 2:1. A total of 209 pupils and 209 adults shall be enrolled from households located in Mbandjock. Similarly, 114 pupils and 114 adults will be recruited in Sa'a. In addition, 57 teachers shall be enrolled in the District of Mbandjock only. A total of 703 participants shall be enrolled during the study.

Start: January 2017

Prevalence Survey of Antimalarial Drug Resistance Markers

Study is cross-sectional and observational with one-time dried-blood spot sample collection from persons with laboratory-confirmed uncomplicated Plasmodium falciparum malaria (mixed or monoinfection). Samples will be analysed for the presence of molecular markers of resistance to ACT partner drugs (gene amplifications and/or other mutations in pfmdr1, gene amplifications of pfpm2, and additional mutations which may be identified during the course of the trial) in the first instance. Testing to detect additional markers of antimalarial drug resistance will also be performed where feasible. Prevalence of mutations will be summarized and mapped to provide intelligence on antimalarial drug resistance in the region of interest.

Start: August 2017

A Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetic Profile of a Single Doses of MMV533.

Phase 1, single -centre study in 2 parts. The study designs for each part are well established for first-in-human studies and are appropriate to assess safety, tolerability and preliminary pharmacokinetics.

Start: August 2020

Automated Microscopy Evaluation Study

Since the introduction of Giemsa stain in 1904 until today, malaria microscopy has been the standard of practice for malaria diagnosis. However, microscopic detection of malaria parasites is labour-intensive, time-consuming and expertise-demanding. Moreover, the slide interpretation is highly dependent on the staining technique and the technician's expertise. To address these, multiple organisations have developed next generation microscopes to move towards a next generation microscope that can improve slide preparation, interpretation or data collection, or a combination of these features. In this study, a prospective evaluation of miLab™ and other next generation automated microscope solutions as well as a malaria rapid diagnostic test (RDT) reader app will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria clinical cases at POC.

Start: October 2020

Innovation Platform

In this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (POC). This study aims to support product development efforts and aims to provide early stage (TLR~5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate development.

Start: October 2020

Efficacy of Three Novel Bi-treated Long Lasting Insecticidal Nets

The massive scale-up of Long Lasting Insecticidal Nets (LLIN) has led to a major reduction in malaria burden (up to 50%) in many sub-Saharan African countries. This progress is threatened by the wide scale selection of insecticide resistant malaria vectors. New types of LLIN combining a mixture of two insecticides or an insecticide and a synergist have been developed to control resistant mosquitoes. The efficacy of three bi-treated LLIN are compared to a standard LLIN in a four-arm, single blinded, cluster-randomized trial in Misungwi district, Tanzania. The arms are; 1/ Royal Guard, a net combining pyriproxyfen (PPF), which is known to disrupt female reproduction and fertility of eggs, and the pyrethroid alpha-cypermethrin, 2/Interceptor G2, LLIN incorporating a mixture of two adulticides with different modes of action; chlorfenapyr and a pyrethroid (alpha-cypermethrin), and 3/ Olyset Plus an LLIN which incorporates a synergist, piperonyl butoxide (PBO), to enhance the potency of pyrethroid insecticides, and 4/ The control arm: Interceptor treated a standard LLIN treated with alpha-cypermethrin. The primary outcome of the trial will be cross-sectional community prevalence of malaria infection (by RDT) in children aged 6 months to 14 years at 12 and 24 months post-intervention.

Start: February 2019

Performance Evaluation of Malaria Plus RDTs

Since their introduction in the late 90's, rapid diagnostic tests (RDTs) have dramatically improved our ability to control malaria, but proved insufficient to support elimination efforts because of their limited sensitivity, especially for P. vivax. In addition, the spread of P. falciparum parasites lacking hrp2 gene jeopardizes the long-term use of P. falciparum-specific HRP2-based RDTs. An existing partnership between Standard Diagnostics (SD), FIND, PATH, and Bill and Melinda Gates Foundation (BMGF) is addressing these limitations by developing two novel malaria RDTs with an analytical sensitivity ten times higher than the currently available malaria RDTs: a P. falciparum-specific test targeting both the HRP2 and PfLDH antigens (Pf Plus), and a P. falciparum/P. vivax combo test additionally targeting the PvLDH antigen (Pf/Pv Plus). These new combo tests with improved sensitivity may become promising diagnostic tools for the detection of malaria, especially in settings where current tests prove to be insufficient due to hrp2 deletion or high burden of P. vivax malaria. In this study, the investigators will perform a prospective evaluation of Pf Plus and Pf/Pv Plus tests in malaria-endemic countries to assess their clinical performance for detection of malaria in their intended-use settings.

Start: June 2021

Short Course Radical Cure of P. Vivax Malaria in Nepal

This study is designed as a multicentre randomized, open label trial to assess the safety and efficacy of a low dose short course PQ treatment (3.5mg/kg total dose given over 7 days) in glucose-6-phosphate dehydrogenase (G6PD) normal patients with P.vivax and P falciparum to reduce the risk of subsequent P.vivax episodes.

Start: May 2021

Early Life Cohort in Papua Indonesia (ELIPI Study)

Malaria remains an important cause of illness in young infants. Our clinical and epidemiological studies in Papua (Indonesia) have shown the magnitude of malaria morbidity in infants in the first 5 years of life, including recurrent episodes of malaria, anaemia, malnutrition and coinfection. Together these contribute significantly morbidity in early life, and almost certainly to the very high infant mortality rates in this region. However the body of knowledge around infant malaria outside of Africa, where both species P. vivax and P. falciparum are prevalent is considerable smaller. The impact of recurrent vivax malaria and severe anaemia on neurodevelopment and growth in young children is unknown in Papua. This study therefore aims to provide longitudinal data on the incidence of symptomatic and asymptomatic malaria (P. falciparum and P. vivax) and the associated risk of anaemia. It also provides an opportunity to assess incidence risk of non-malaria febrile illnesses and bacterial co-infections and the long term outcomes in terms of neurodevelopment and growth in a vulnerable age group. The study is a continuation from two already established cohort studies: "STOP MIP", which enrolled pregnant women and followed them until delivery and a "baby-cohort", which enrolled babies from mothers included in the cohort and followed them through their first year of life. Continuous follow up of those babies until they are 4 years old will increase our understanding of long term impact especially of vivax malaria. The cohort will be linked to a randomized controlled trial (RCT) and will offer cohort patients to be enrolled into the RCT when they are diagnosed with malaria (symptomatic), allowing to estimate treatment effectiveness.

Start: August 2016

Evaluation of the Implementation and Effectiveness of Intermittent Preventive Treatment for Malaria Using Dihydroartemisinin-piperaquine on Reducing Malaria Burden in School Aged Children in Tanzania

In Tanzania, according to the National Malaria Control Programme (NMCP), malaria prevalence has declined from an average of 18.1% in 2008 to 7% in 2017, marked as an epidemiological transition from meso-endemic to hypo-endemic levels with variation across and within regions and/or councils. Children of school-age have become increasingly more vulnerable as compared to those aged less than five years. In high-transmission settings, up to 70% of school-aged children harbour malaria parasites which is mostly asymptomatic, accounting for around 50% of the mortality, 13-50% of all school absenteeism. The NMCP developed a supplementary malaria midterm strategic plan (SMMSP 2018-2020) to customise malaria interventions by stratifying the burden of malaria in Tanzania mainland and recommended use of Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment in school children (IPTsc) in high malaria strata. The investigators plan to evaluate the implementation of IPTsc using DP, given three times a year, for evidence on the operational feasibility and effectiveness of IPTsc on clinical malaria incidence at a high endemic area in Handeni District Council (DC), Handeni Town Council (TC) and Kilindi DC of Tanga region, Tanzania. The study is an effectiveness-implementation hybrid trial to assess feasibility and effectiveness of IPTsc using DP against standard of care (control). Wards in the three study districts (Handeni DC, Handeni TC and Kilindi DC) will be the randomisation unit (clusters). Each ward will be randomised to implement IPTsc or not (control). In all wards in the IPTsc arm, the interventional drugs (DP) will be given at an interval of four months, three times a year. For study evaluation of the impact of intervention, in each district representative randomly selected wards, will provide randomly selected school per ward (24 in total) to formulate part of evaluable children per intervention. Mixed design methods will be used to assess the feasibility and acceptability of implementing IPTsc as part of a more comprehensive school children health package. The study is expected to be operationally feasible given existing school health programme for Neglected Tropical Disease (NTD) control and the school net programme (SNP). IPTsc is expected to increase malaria case management effectiveness and to have additional effect in reducing the burden of disease on top of optimal access to malaria case management (MCM) and malaria vector control (MVC) initiatives e.g. early diagnosis and treatment, and insecticide-treated nets (ITNs) coverage, respectively.

Start: July 2020

Star Homes Project 2

Malaria, pneumonia and diarrhoea causes a lot of illness in children in Tanzania and the study want to find better ways of protecting people against these diseases and want to find out if the type of house design can affect the general health of children living in the house.

Start: January 2021

Epidemiology Study of Malaria Transmission Intensity in Sub-Saharan Africa

This epidemiology study is planned to run in parallel with the EPI-MAL-002 and EPI-MAL-003 studies, enrolling from the same health and demographic surveillance system (HDSS) (or equivalent system) populations. The co-primary objectives are to produce longitudinal estimates of parasite prevalence in humans, and record malaria control measures usage in areas where EPI-MAL-002 and EPI-MAL-003 studies will take place.

Start: October 2014

Impact of Malaria on Pregnant Women in Ouelessebougou, Mali

Background: Malaria is a serious disease. It is passed by infected mosquitoes. In many parts of Africa, malaria continues to be the main cause of death in young children and pregnant women. Researchers want to find out more about how malaria affects pregnant women and their babies. Objectives: To study the rate of miscarriage and stillbirth during the second and third trimesters among women in a certain district in Mali. To study rates of malaria infection over time among pregnant women and children in this area. Eligibility: Pregnant women of any age and pregnancy stage and their newborns. They must live in Ouelessebougou, Mali. Children up to 10 years old who live there. Design: Information about the study will be shared at community meetings, during visits to the health centers, and during census updates. Participants will read and sign a consent form. Pregnant women will be screened to see if they are eligible. They may have a urine test. They may have an ultrasound to date their pregnancy. Ultrasound uses sound waves to take pictures of the body. Women will be enrolled in the study after they have their babies. Participants may have a physical exam. Some participants will provide a finger/heel prick blood sample. Participants will complete a questionnaire. They will be asked about: Medical history Antimalarial and other interventions Socioeconomic status Their pregnancy Previous pregnancies Health of their newborn...

Start: February 2017

Evaluation of Targeted Mass Drug Administration for Malaria in Ethiopia

Reactive and proactive case detection measures are widely implemented by national malaria elimination programs globally. Similarly, the Ethiopian Federal Ministry of Health decided to include reactive case detection (RCD) and targeted mass drug administration (tMDA) approaches as part of their elimination strategy, along with rigorous evaluation. This study aims to evaluate the impact on annual parasite incidence (API) and cost-effectiveness of implementing tMDA and RCD within a 100-meter radius of passively detected index case, compared with standard of care in the control arm. In addition, cross-sectional surveys will measure the change in malaria prevalence over the two-year study intervention period. The aim is to generate evidence to inform Ethiopia's national strategy for malaria elimination.

Start: January 2020