Vivax Malaria Clinical Trial
Official title:
The Population Pharmacokinetics of Chloroquine for the Treatment of Uncomplicated P.Vivax Malaria in Pre- and Post-partum Women.
For the treatment of P.vivax the standard treatment is chloroquine. There is a growing body of evidence suggesting that pregnant women may require different doses of drugs, including antimalarials due to the physiological changes of pregnancy. It is important that any drug used in pregnant women it is given at the correct dose. The only way to evaluate this is by pharmacokinetic studies. The investigators propose to evaluate the pharmacokinetics of chloroquine when use to treat P.vivax in the 2nd or 3rd trimester of pregnancy. The same evaluation in the same woman post-partum is required as a control.
For the treatment of P.vivax the standard treatment is chloroquine. There is a growing body
of evidence suggesting that pregnant women may require different doses of drugs, including
antimalarials, due to the physiological changes of pregnancy. It is important that any drug
used in pregnant women is given at the correct dose. The only way to evaluate this is by
pharmacokinetic studies. We propose to evaluate the pharmacokinetics of chloroquine when use
to treat P.vivax in the 2nd or 3rd trimester of pregnancy. The same evaluation in the same
woman post-partum is required as a control.
The two most recent pharmacokinetic publications conclude differently on chloroquine dosing
in pregnant women: one suggests no dose adjustment and the other that a higher dose is
probably needed. It is crucial that pregnant women are dosed correctly to maximise cure and
minimize the chance for recurrence and the harmful effects of malaria. The proposed study on
the pharmacokinetics of chloroquine treatment in pregnant women will solve this dilemma.
Pregnant women on the Thai-Burmese border are encouraged to attend antenatal care often for
early detection and treatment of malaria. Low birth weight due to P.vivax affects
primigravida and multigravida, not just primarily primigravida as with
P.falciparum(highlighted in the attached reference). Hence it is important to consider these
women for radical cure. This is not possible during pregnancy as primaquine is
contraindicated so the next best time is in the post-partum period. During the post-partum
period the woman remains in close contact with midwives for infant care and for their
personal health. The midwives also have a record of malaria attacks during pregnancy.
We know more about chloroquine than any other antimalarial used in pregnancy. It has been
widely used for prevention and treatment of malaria in pregnancy and in women with autoimmune
disease such systemic lupus and rheumatoid arthritis high doses of hydroxychloroquine have
been given daily including during the first trimester of pregnancy. Although data from
prospective clinical trials of malaria are limited, this drug is considered safe in all
trimester of pregnancy and in lactation.
For treatment of uncomplicated P.vivax WHO recommends chloroquine and primaquine where
P.vivax remains chloroquine sensitive. A 14 day course of primaquine is recommended for
radical cure of P.vivax. WHO advises not to use primaquine during pregnancy or in severe
G6PD. WHO permits the use of primaquine during lactation if the breast fed infant is not G6PD
deficient.
The possibility that women with recurrent P.vivax in the same pregnancy may have chloroquine
resistant P.vivax needs to be considered. While the combination of chloroquine and primaquine
cannot be used in pregnancy and the safety and efficacy of ACTs are still undergoing
evaluation we need to explore alternatives to chloroquine for such cases. ACTs are
recommended for chloroquine resistant P.vivax by WHO and one ACT considered safe in pregnancy
and lactation is a 7 day course of artesunate-clindamycin.
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