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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.

Women sitting on the floor in a meeting
WWARN Primaquine Indian Region Study Group

An individual patient data meta-analysis from India and regional countries to inform the local safety, tolerability and efficacy of primaquine regimens for radical cure of P. vivax

school children in class
Paediatric Primaquine

A series of individual patient data meta-analyses to investigate the safety, tolerability and efficacy of primaquine in paediatric patients with P. falciparum, P. vivax or P. ovale malaria.

medic examines infant, Cambodia
Vivax Adherence Study Group

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

Medical technicians working with bags of blood
Vivax Haematological Study Group: Part 2

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

mothers and babies in health centre
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.

Mother and child wait outside health clinic
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

Photo shows women in Ethiopia
Dihydroartemisinin-Piperaquine for Intermittent Preventive Treatment in Pregnancy (IPTp-DP) Study Group

The Dihydroartemisinin-Piperaquine for Intermittent Preventive Treatment in Pregnancy Study Group aims to determine the safety and efficacy of intermittent preventive treatment in pregnancy (IPTp) with dihydroartemisinin-piperaquine (DP) compared to IPTp with sulfadoxine-pyrimethamine (SP), for the prevention of malaria and adverse birth outcomes among pregnant women in sub-Saharan Africa.

Credit: Lindsay Mgbor/Department for International Development
Malaria in Pregnancy Infant Study Group

Exploring the impact of malaria during pregnancy on infant anaemia, malaria, morbidity and growth – an individual participant meta-analysis. 

Credit: Dominic Chavez, World Bank
Intermittent preventive treatment in pregnancy (IPTp) and SP-resistance-associated mutations Study Group

The overall aim of the IPTp and SP-resistance-associated mutations Study Group is to quantify how parasites with the sextuple mutant pfdhps and pfdhfr haplotype* modify the effect of IPTp on maternal and infant outcomes.

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Clinical Trials Methodology Study Group for P. falciparum

This Study Group is exploring key study design and analytical factors which affects derived clinical efficacy of antimalarials. 
Statistical analyses have commenced and preliminary results of ongoing analyses will be shared at EDCTP Forum 2016 (Lusaka, Zambia) and ASTMH 2016 (Atlanta, USA). Publications are expected in 2018.

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.
 

(c) UNICEF Pierre Holz 2007
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.

Pipetting of blood in a biosafety cabinet
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)

Blood sample from child
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.

Plasmodium falciparum Gametocyte
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

A mother and child receiving malaria medication in Angola
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

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