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.

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Dominic Chavez World Bank
A meta-analysis of individual patient data (IPD) to determine the effect of antiretroviral (ARV) drug-drug interactions and HIV disease on artemether ...

A meta-analysis of individual patient data (IPD) to determine the effect of antiretroviral (ARV) drug-drug interactions and HIV disease on artemether and lumefantrine pharmacokinetics (PK). The analysis aims to contribute evidence needed to inform recommendations on the use and optimal dosing of artemether-lumefantrine (AL) in HIV-infected patients.

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Sub-study groups include the Artemether-Lumefantrine / ARV PK Study Group and the ACT-ARV Safety Study Group.
pregnant woman
Determining the effects of pregnancy on piperaquine pharmacokinetics. The analysis aims to contribute evidence needed to inform recommendations on the...

Determining the effects of pregnancy on piperaquine pharmacokinetics. The analysis aims to contribute evidence needed to inform recommendations on the use and optimal dosing of piperaquine in pregnant women.

Determining the effects of pregnancy on piperaquine pharmacokinetics. The analysis aims to contribute evidence needed to inform recommendations on the use and optimal dosing of piperaquine in pregnant women.

 

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This Study Group aims to bring together and explore the latest evidence on the prevalence of molecular markers associated with antimalarial drug resis...

This Study Group aims to bring together and explore the latest evidence on the prevalence of molecular markers associated with antimalarial drug resistance in West African Countries.

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This Study Group will explore the link between P. vivax recurrence and prior P. falciparum treatment, including increased risk of vivax para...

This Study Group will explore the link between P. vivax recurrence and prior P. falciparum treatment, including increased risk of vivax parasitaemia due to acute malaria infection.

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The Subpatent Malaria and Pregnancy Outcome Study Group aims to explore the relationship between subpatent Plasmodium falciparum malaria inf...

The Subpatent Malaria and Pregnancy Outcome Study Group aims to explore the relationship between subpatent Plasmodium falciparum malaria infection and pregnancy outcome

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pregnant woman having ultrasound
The sulphadoxine-pyrimethamine (SP) resistance Data Access Group’s aim is to provide maps and open access to the most recent data on molecular markers...

The sulphadoxine-pyrimethamine (SP) resistance Data Access Group’s aim is to provide maps and open access to the most recent data on molecular markers of SP resistance to help policy makers make informed decisions with regard to use of SP for intermittent preventive treatment of malaria in pregnancy (IPTp) or seasonal malaria chemoprevention (SMC).

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Pregnant woman sitting against a wall
The Alternative MiP Prevention Strategies (AMPS) Study Group’s aim is to determine the safety and efficacy of novel strategies for the control of mala...

The Alternative MiP Prevention Strategies (AMPS) Study Group’s aim is to determine the safety and efficacy of novel strategies for the control of malaria in pregnancy, specifically intermittent screening and treatment (ISTp), with an artemisinin-based combination therapy (ACT).

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Pregnant woman
Assessing the efficacy of a range of antimalarials used for the treatment of P. falciparum malaria in all trimesters of pregnancy in Africa ...

Assessing the efficacy of a range of antimalarials used for the treatment of P. falciparum malaria in all trimesters of pregnancy in Africa and Asia

The MiP Treatment Efficacy Study Group was formed in July 2016, with a call to interested researchers with relevant data sets.

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Woman holding baby
The Sulphadoxine-Pyrimethamine (SP) resistance Study Group’s aim is to provide open access to, and establish maps with, the most recent data on SP res...

The Sulphadoxine-Pyrimethamine (SP) resistance Study Group’s aim is to provide open access to, and establish maps with, the most recent data on SP resistance to inform policy decisions on the clinical effectiveness of SP when provided as part of intermittent preventive treatment of malaria in pregnancy (IPTp) or seasonal malaria chemoprevention (SMC).

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Pregnant woman
The Alternative MiP Prevention Strategies (AMPS) Study Group’s aim is to determine the safety and efficacy of novel strategies for the control of mala...

The Alternative MiP Prevention Strategies (AMPS) Study Group’s aim is to determine the safety and efficacy of novel strategies for the control of malaria in pregnancy including intermittent preventive therapy (IPTp) with dihydroartemisinin-piperaquine (DP) and intermittent screening and treatment (ISTp) with DP or artemether-lumefantrine (AL).

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first-trimester ultrasound
The First Trimester Safety of ACTs Study Group’s aim is to establish the evidence-base and safety profile to inform decision-making on the use of arte...

The First Trimester Safety of ACTs Study Group’s aim is to establish the evidence-base and safety profile to inform decision-making on the use of artemisinin combination therapies in the first trimester of pregnancy.

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The Piperaquine Safety Study Group’s aim is to establish the evidence-base and safety profile to inform decision-making on the use and optimal dosing ...

The Piperaquine Safety Study Group’s aim is to establish the evidence-base and safety profile to inform decision-making on the use and optimal dosing of dihydroartemisinin-piperaquine in all key target populations.

The study group call for contributors opened in June 2016 with a first scoping meeting held in July. Data collection is planned to close by end of 2016, with analysis due in 2018-2019.

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An analysis of pooled individual patient data to determine the effect of antiretroviral (ARV) drug-drug interactions and HIV disease on lumefantr...

An analysis of pooled individual patient data to determine the effect of antiretroviral (ARV) drug-drug interactions and HIV disease on lumefantrine pharmacokinetics (and pharmacodynamics).

This study group has just opened for data collection. If you have any data you would like to share, or if you would like to participate in the project, please contact pharmacology@wwarn.org.

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gametocyte
Pooled analyses of the efficacy and safety of single low-dose primaquine to interrupt P. falciparum malaria transmission.Data collection has closed an...

Pooled analyses of the efficacy and safety of single low-dose primaquine to interrupt P. falciparum malaria transmission.

Data collection has closed and curation is ongoing. Analysis and draft publications are planned for circulation to the Group by the June of 2017.

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A pooled analysis assessing the effect of mg/kg dosing strategies on the risk of treatment failure in patients treated with the currently recommended ...

A pooled analysis assessing the effect of mg/kg dosing strategies on the risk of treatment failure in patients treated with the currently recommended dose of artesunate-mefloquine (AS-MQ).

Research groups with relevant data have been contacted with data collection and curation still ongoing. Analysis will start in late 2016 and drafting publication in expected in 2018.

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Modelling the protective effect of Artesunate-Amodiaquine (AS-AQ)A pooled analysis to assess the post-treatment prophylactic effect of artesunate-amod...

Modelling the protective effect of Artesunate-Amodiaquine (AS-AQ)

A pooled analysis to assess the post-treatment prophylactic effect of artesunate-amodiaquine (AS-AQ). The group is quantifying the duration of post-treatment prophylaxis mediated by AS-AQ and how it depends on host factors such as .

The Study Group closed in January 2014. The AS-AQ Post-Treatment Prophylaxis Study Group manuscript is under review at BMC Medicine. 

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Analysis of haematological response before and after antimalarial treatment. A pooled analysis to understand the normal haematological response a...

Analysis of haematological response before and after antimalarial treatment. 

A pooled analysis to understand the normal haematological response and recovery following the treatment of uncomplicated malaria. The group will work together to quantify the risks and benefits of different treatment options of both ACTs and other antimalarials.

Data meeting the inclusion criteria has been collected and standardised from over 70,000 patients. Data gathering, curation and data analysis have been completed. A manuscript is under review of study group members and expected to be submitted for publication Q2 2020. 

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Development of statistical methods to infer the relationship between the percentage of resistant infections, parasite clearance half-life and the prop...

Development of statistical methods to infer the relationship between the percentage of resistant infections, parasite clearance half-life and the proportion of treated individuals still positive on days one, two and three of treatment

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The AL Dose Impact Study Group was first established in 2011. The Study Group first met in December 2011 at the ASTMH Annual Meeting to discuss the St...

The AL Dose Impact Study Group was first established in 2011. The Study Group first met in December 2011 at the ASTMH Annual Meeting to discuss the Study Group governance and publication policy. The Study Group closed in March 2013. The latest results were presented at the 2014 ASTMH Annual Meeting in New Orleans, USA.

The artemether-lumefantrine (AL) Dose Impact Study Group found that the efficacy of the combination was lowest in young children from Asia and young underweight children from Africa, suggesting that a higher dose regimen should be evaluated in these groups. The manuscript for this Study Group was published by the Lancet Infectious Diseases in March 2015: The effect of dose on the antimalarial efficacy of artemether-lumefantrine: a systematic review and pooled analysis of individual patient data

Briefly, data from 66 clinical trials (n=15,529) conducted between 1998 and 2012, including eight unpublished studies and 58 published, studies representing 59 per cent of the targeted published literature on AL treatment were shared with WWARN. 61 studies (14,327 patients) were included in the final analysis. Of those patients included in the final analysis, 82.4 per cent were from Africa, 16.5 per cent from Asia and 1.1 per cent from South America.

Download a presentation from the AL Dose Impact Study Group.

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Baseline information on parasitological response to ACTs in AfricaA pooled analysis to assess the baseline early parasitological response after artemi...

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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Analysing PK/PD data to identify inadequate drug exposure and inform dosageA pooled piperaquine pharmacokinetic analysed the exposure to piperaquine i...

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.

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Analysing PK/PD data to identify inadequate drug exposure and inform antimalarial dosageA pooled pharmacokinetic/pharmacodynamics (PK/PD) analysis of ...

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)

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