Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Comparison of efficacy, defined as PCR corrected adequate clinical and parasitological response (ACPR) at day 42 versus day 63 |
|
63 days |
|
Other |
Comparison of efficacy, defined as adequate clinical and parasitological response (ACPR) at day 42 versus day 63 |
|
63 days |
|
Other |
Proportions of recurrent infections with parasites carrying mutations of known functional significance |
|
63 days |
|
Other |
Proportions of specimens collected at baseline with parasites carrying mutations of known functional or operational significance |
Mutations include pfkelch13, pfcrt, pfmdr1, pfdhfr, pfdhps, pfplasmepsin2 , partial or complete deletions of pfhrp2 and other current parasite genetic markers associated with resistance or identified over the course of the study |
baseline |
|
Other |
Number of samples from drug sensitive and resistant parasites that have common genomic patterns that associate with in vivo or in vitro parasite drug sensitivity phenotypes. |
|
63 days |
|
Other |
Survival rate or IC50 in in vitro drug susceptibility assay of P. falciparum to artemisinins and partner drugs according to study sites and genotype |
|
63 days |
|
Other |
Percent agreement and/or KAPPA score of SNPs assessed from dry blood spots versus from whole genome sequencing in leukocyte depleted blood samples |
|
63 days |
|
Other |
Correlation between qPCR based versus microscopy based assessments of parasite clearance dynamics |
|
14 days |
|
Other |
Correlation of parasite clearance metrics as assessed by microscopy versus digital microscopy |
|
3 days |
|
Other |
Number of samples from drug sensitive and resistant parasites obtained before treatment and 6, 12, and 24 hours after start of treatment that can be assigned to a common transcriptomic pattern. |
|
63 days |
|
Other |
Levels of RNA transcription coding for male or female specific gametocytes at admission up to day 14, stratified by the presence of gametocytes at enrolment |
|
14 days |
|
Other |
Correlation between the host genotype and the pharmacokinetics and pharmacodynamics of antimalarials |
Host genotype (e.g., CYP2D6, CYP3A4, KCNQ1/LQT1, KCNH2/LQT2, SCN5A/LQT3) |
42 days |
|
Other |
Correlations between the place of residence, work, recent travel history assessed by interview and mobile phone records to identify behaviours and risk factors associated with malaria infection. |
|
63 days |
|
Other |
Correlation between titres of antibodies against malaria parasite antigen and efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR) |
|
63 days |
|
Other |
Correlation between titres of antibodies against malaria parasite antigen and efficacy defined as adequate clinical and parasitological response (ACPR) |
|
63 days |
|
Primary |
Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR). |
|
42 days |
|
Secondary |
Efficacy defined as PCR corrected adequate clinical and parasitological response (ACPR) |
|
63-day |
|
Secondary |
Efficacy defined as adequate clinical and parasitological response (PCR) |
|
63-day |
|
Secondary |
Efficacy defined as adequate clinical and parasitological response (ACPR) |
|
42-day |
|
Secondary |
Parasite clearance half-life |
|
7 days |
|
Secondary |
proportion of subjects with microscopically detectable P. falciparum parasitaemia |
|
3 days |
|
Secondary |
Fever clearance time |
Time taken for the tympanic temperature to fall below 37.5 ºC in patients who were febrile at inclusion |
7 days |
|
Secondary |
Proportion of subjects with gametocytemia during and after treatment stratified by presence of gametocytes at enrolment |
|
63 days |
|
Secondary |
Number of adverse events |
|
42 days |
|
Secondary |
Number of serious adverse events |
Including markers of hepatic, renal or bone marrow toxicity |
42 days |
|
Secondary |
Number of cardiotoxicity events |
In particular QTc-interval above 500 ms or an increase > 60 ms above baseline values at timepoint H4 and H52/H64 and between these time points |
52 or 64 hours depends on treatment arm |
|
Secondary |
Change in haemoglobin stratified for G6PD status/genotype |
|
28 days |
|
Secondary |
Proportion of subjects requiring retreatment due to vomiting within 1 hour after administration of the study drugs |
|
1 hour |
|
Secondary |
Proportion of subjects that reports completing a full course of observed TACT |
|
3 days |
|
Secondary |
Proportion of subjects that reports completing a full course of observed ACT |
|
3 days |
|
Secondary |
Pharmacokinetic profiles and interactions (including Cmax) of artemisinin-derivatives and partner drugs in ACT and TACT treated subjects in correlation with pharmacodynamics measures of drug efficacy |
|
42 days |
|
Secondary |
Pharmacokinetic profiles and interactions (AUC) of artemisinin-derivatives and partner drugs in ACT and TACT treated subjects in correlation with pharmacodynamics measures of drug efficacy |
|
42 days |
|
Secondary |
Plasma levels of partner drugs in correlation with treatment efficacy and treatment arm |
|
7 days |
|