Randomized, multicentre assessment of the efficacy and safety of ASAQ – a fixed-dose artesunate-amodiaquine combination therapy in the treatment of uncomplicated Plasmodium falciparum malaria

Table 1 Investigational plan

STUDY PARAMETERS	REFERENCE DAYS								Unplanned visits
STUDY PARAMETERS	D0	D1	D2	D3	D7 ± 1d	D14 ± 1d	D21 ± 1d	D28 ± 1d	Unplanned visits
History	X
Age/Weight/Height/sex	X
Physical examination/Vital signs	X	X	X	X	X	X	X	X	X
Clinical safety	X	X	X	X	X	X	X	X	X
Parasitological examination	X	X	X	X	X	X	X	X	X
Haemoglobin^a	X				X	X^b		X	(X)
Platelets + leukocytes	X				X	X^b		X	(X)
Blood glucose^a	X								(X)
Blood creatinine	X				X	X^b		X	(X)
AST/ALT	X				X	X^b		X	(X)
Preparation of filter paper blood spot samples for PCR	X				X	X	X	X	(X)
Study treatment	X	X	X
Concomitant medication	X	X	X	X	X	X	X	X	(X)

^a in the event of onset of severe indicators; ^b in the event of an abnormal value on D7; (x) if necessary.

ISSN: 1475-2875