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Study groups

WWARN facilitates a number of collaborative Study Groups to undertake individual patient data meta-analyses to answer specific research questions about malaria treatments and antimalarial drug resistance. Gathering and combining data sets from multiple studies increases sample sizes, so that effects, including smaller effects, and effects on sub-populations can be identified with greater certainty. Working together and combining data from different regions and populations is improving our understanding of drug resistance and strengthening global efforts to control and eventually eliminate malaria.

Vivax Adherence Study Group

Analysis of the effect of adherence to primaquine on the risk of recurrence in patients with Plasmodium vivax malaria.

Vivax Haematological Study Group: Part 2

An analysis of the effect of recurrences and primaquine dose on haematological recovery.

Plasmodium vivax Fever Study Group

The Plasmodium vivax fever study group aims to estimate parasitaemia thresholds for febrile patients who present for treatment and determine the pyrogenic density of vivax parasitaemia in recurrent infections.

Paediatric single low-dose primaquine efficacy study group

The paediatric single low-dose (SLD) primaquine efficacy study group aims to assess and compare the efficacy of SLD primaquine for transmission blocking of Plasmodium falciparum in young children (under 5 years of age) with that in older children and adults

Paediatric single low-dose primaquine safety study group

The paediatric single low-dose (SLD) primaquine safety study group aims to describe and compare the safety of SLD primaquine for transmission blocking of Plasmodium falciparum in young children (under 5 years of age) with that in older children and adults.

Vivax and Ovale Paediatric Primaquine Gastrointestinal Tolerability Study Group

Analysis of how age impacts the effect of primaquine dose on gastrointestinal tolerability in patients with Plasmodium vivax and Plasmodium ovale malaria

Vivax and Ovale Paediatric Primaquine Efficacy Study Group

Analysis of how age impacts the effect of primaquine dose on efficacy in patients with Plasmodium vivax and Plasmodium ovale malaria

Vivax and Ovale Paediatric Primaquine Haematological Safety Study Group

Analysis of how age impacts the effect of primaquine dose on haematological safety in patients with Plasmodium vivax and Plasmodium ovale malaria

Primaquine Efficacy, Safety and Tolerability Study Group

Analysis of the effect of primaquine dose on the efficacy, safety and tolerability in patients with Plasmodium vivax malaria

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Ivermectin Exposure in Small Children Study Group

The Ivermectin Exposure in Small Children Study Group aims to assess safety profile of ivermectin exposure in children less than 15 kilograms

Vivax Haematology Study Group

Analysis of the consequences of symptomatic Plasmodium vivax infections on anaemia before and after antimalarial treatment 

Correlation between K13 mutations and clinical phenotype Study Group

A pooled analysis on the relationship between K13 molecular marker and parasite clearance data. The Study Group closed to new participants in December 2015. The analysis was completed between 2016–2018 and the group published in January 2019. WWARN K13 Genotype-Phenotype Study Group. Association of mutations in the Plasmodium falciparum Kelch13 gene (Pf3D7_1343700) with parasite clearance rates after artemisinin-based treatments—a WWARN individual patient data meta-analysis. BMC Medicine. January 17, 2019.
 

Antimalarial – Lumefantrine POP/PK Study Group

Determining the optimal Artemether-lumefantrine antimalarial dosing for young children and pregnant women: A pharmacokinetic-pharmacodynamic meta-analysis.

Vivax Recurrence Study Group

Analysis of risk factors of Plasmodium vivax early and late recurrence. Published in July 2018.

Amodiaquine PK/PD Study Group

Analysing PK/PD data to identify inadequate drug exposure and inform antimalarial dosage
A pooled pharmacokinetic/pharmacodynamics (PK/PD) analysis of amodiaquine (AQ) is complete. The analysis focused on a population pharmacokinetic/pharmacodynamic model of amodiaquine and its active metabolite desethyl-amodiaquine in patients who received either amodiaquine as a monotherapy regimen or in combination with artesunate. The full covariate analysis explored the effects of fixed versus loose dose formulations, age, nutrition status, baseline parasitemia and sample matrix.
Publication: WWARN Amodiaquine PK Study Group. Population Pharmacokinetics of the Antimalarial Amodiaquine: a Pooled Analysis to Optimise Dosing. Denti et al. Antimicrobial Agents and Chemotherapy. 2018, Sept 24:62(10)

Piperaquine PK/PD Study Group

Analysing PK/PD data to identify inadequate drug exposure and inform dosage
A pooled piperaquine pharmacokinetic analysed the exposure to piperaquine in different populations in order to identify patient groups at particular risk of treatment failure, such as young children and pregnant women. The model can be used to optimise the dose in these vulnerable populations in order to give all patients an equal chance of cure.
The pharmacokinetic analysis has been finalised and published.

Gametocyte Carriage Study Group

A pooled analysis of Plasmodium falciparum gametocyte carriage
The purpose of this Study Group is to assess the risk factors for treatment failure associated with gametocyte carriage and clearance across a range of endemic settings and antimalarial drug treatments. To achieve this requires a standardised database and a set of metrics which are derived in a systemic manner. Data within the WWARN Data Centre provide an excellent opportunity. 
Study published on 24 July 2016:
WWARN Gametocyte Study Group. Gametocyte carriage in uncomplicated Plasmodium falciparum malaria following treatment with artemisinin combination therapy: a systematic review and meta-analysis of individual patient data. BMC Medicine 2016 14:79 DOI: 10.1186/s12916-016-0621-7

Lumefantrine PK/PD Study Group

Analysing PK/PD data to identify inadequate drug exposure and inform dosage
A pooled lumefantrine pharmacokinetic-pharmacodynamic (PK/PD) analysis is being conducted to evaluate the exposure to lumefantrine in different populations to identify patient groups (such as young children and pregnant women) at particular risk of treatment failure. Further, to identify the pharmacokinetic-pharmacodynamic relationship of lumefantrine in the treatment of uncomplicated falciparum malaria. The group will use the the population PK-PD analysis and model developed to conduct in-silico dose optimisations.
Publication details:
WWARN Lumefantrine PK/PD Study Group. 'Artemether-lumefantrine treatment of uncomplicated Plasmodium falciparum malaria: a systematic review and meta-analysis of day 7 lumefantrine concentrations and therapeutic response using individual patient data'. Published in BMC Medicine 2015. 13:227  doi:10.1186/s12916-015-0456-7.
Follow-on analysis:
Artemether-lumefantrine dosing for malaria treatment in young children and pregnant women: A pharmacokinetic-pharmacodynamic meta-analysis. Published in PLOS Medicine June 2018. 15 (6): 1-27. Doi: 10.1371/journal.pmed.1002579  PMID: 29894518

ACT Africa Baseline Study Group

Baseline information on parasitological response to ACTs in Africa
A pooled analysis to assess the baseline early parasitological response after artemisinin combination therapy (ACT) treatments in sub-Saharan Africa. The analysis compiles the day 3 parasite positivity rates (PPR) in patients with uncomplicated Plasmodium falciparum malaria enrolled in ACT clinical efficacy trials.
The Study Group closed in March 2013. A draft manuscript has been finalised and shared with the Study Group members in February 2015. The study was published in BMC Medicine in September 2015.
Publication details: 
WWARN Artemisinin based Combination Therapy (ACT) Africa Baseline Study Group, Clinical determinants of early parasitological response to ACTs in African patients with uncomplicated falciparum malaria: a literature review and meta-analysis of individual patient data. BMC Medicine 2015, 13:212 doi:10.1186/s12916-015-0445-x

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