Chloroquine (CQ) remains an alternative cheap, safe and widely available drug. Our previous
research has shown that double (50 mg/kg) standard dose CQ given in split doses had a 95%
efficacy and was well tolerated and safe. Still, safety could be an issue when the dose of CQ
is increased. Severe adverse events are caused by high peak concentrations of CQ. Using split
doses of CQ avoids high peak concentrations enabling the safe administration of high doses,
however, pharmacokinetic data are lacking.
Children included in the study will be given 50 mg/kg as split doses over 3 days or 70 mg/kg
as split doses over 5 days. Treatment will be observed. Drug concentrations and adverse
events will be monitored. On day 1, children and their mother/guardian will be requested to
stay at the health centre between 9 am and 6 pm.
Fifteen children aged 2-10 years with uncomplicated P. falciparum malaria and fulfilling the
inclusion criteria will be recruited into each study arm.
Following the end of treatment, the children will be seen on the morning of day 7, 14, 21 and
28.
Any child wishing to withdraw during the treatment phase and any child with reparasitaemia
during the follow up will be given rescue treatment with arthemeter-lumefantrine or quinine
according to treatment guidelines in Guinea-Bissau.
Final analysis will include a description of included children, proportions of adverse events
and any serious adverse events, drug concentrations and their relation to adverse events, the
proportion of children withdrawn or lost to follow up, the cumulative PCR corrected and
uncorrected success and failure rates on day 28 and the proportion of early, late clinical
and late parasitological treatment failures.