WWARN Pharmacology Group

Submitting pharmacology data to WWARN

Achieving adequate antimalarial drug concentrations in the blood, known as pharmacokinetics, is essential for treating malaria. Our Pharmacology Group is working to provide evidence to improve dosing regimens in patient populations, particularly for vulnerable groups such as small children and pregnant women.

  • Contribute individual patient antimalarial PK data to WWARN’s secure, online Data Centre
  • The value of PK data is greatly enhanced if linked to clinical efficacy data (ideally from studies following patients for a minimum 28 days post-treatment), as this will help us better understand drug exposure effects on treatment response. If available, data will be stratified based on molecular and in vitro data from the same patient,
  • Antimalarial PK/PD data is also requested from intermittent preventative therapy and healthy volunteer studies to understand malaria disease effects on drug exposure,
  • Data can be uploaded in any file format (see Pharmacology Data Variables box for required and preferred data to be used to derive variables indicating antimalarial drug exposure),
  • Data contribution should be accompanied by a data dictionary explaining the variables and coding  In this way, all studies presented on the WWARN Explorer visualisation tool will have had outcomes derived using the same statistical method, increasing comparability across studies.

Pharmacology Data Variables

Required for each submitted dataset:

Optional for each submitted dataset:

Unique patient identifier (anonymised)

Pregnancy status

Malaria status: e.g. Symptomatic Asymptomatic malaria / Intermittent preventive treatment / Mass Drug Administration healthy volunteer

Co-morbidity (specify)

Malaria species: P. falciparum / P. vivax / P. ovale / P. malariae / P. knowlesi / Mixed infection (specify species)

Was each dose administered with food?

Age  in years or months

 

Gender

 

Weight

 

Treatment regimen

 

Treatment allocation (e.g. supervised versus unsupervised administration)

 

Manufacturer and formulation

 

Number of tablets/amount in mg/kg for each dose

 

Date (and time, if available) of each dose

 

Date/time of sampling for each drug/metabolite concentration 

 

Drug/metabolite concentration at each sample time

 

Treatment outcome, day of recurrence and PCR result (if available) 

 

Asexual parasite densities at each follow up time (if available) 

 

Gametocyte densities at each follow up time (if available) 

 

Data about the study

The following data can be provided by submitting a published study:

  • Country(ies) and site(s) where the study was conducted
  • Year(s) the study was conducted
  • Manufacturer
  • Sample matrix 
  • Protocol sampling times (if actual sampling date / time not recorded)
  • Lower (and upper) limit of quantification for each drug/metabolite assayed

For more information on submitting pharmacology data to the WWARN Data Centre or collaborating with the Pharmacology Group, please email Lesley Workman on pharmacology [at] wwarn [dot] org