Improving Anti-malarial Treatment Options in Guinea-Bissau - Part A
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
Plasmodium falciparum causes malaria and approximately 665 000 deaths each year. chloroquine
and sulphadoxine-pyrimethamine resistant P. falciparum are widespread. An artemisinin
derivative combined with lumefantrine, amodiaquine or piperaquine is therefore recommended
for the treatment of malaria in Africa. However, artemisinin resistance appears to be
developing and resistance/tolerance to amodiaquine and lumefantrine exists. We are presently
conducting a study in Guinea-Bissau. Preliminary data indicates that the effectiveness and
availability of artemether-lumefantrine (AL), the 1st line drug, is poor. Consequently there
is a need for another treatment option. Dihydroartemisinin-piperaquine (DP) has been shown to
be efficacious and well tolerated in several African countries and is therefore such an
option. A clinical trial comparing the safety and efficacy of artemether-lumefantrine and
dihydroartemisinin-piperaquine is therefore needed.
Parents to children seeking Bandim Health Centre (CSB) with symptoms compatible with malaria
will be informed of the study. If accepting and the child fulfil the inclusion criteria, the
child will be randomised to treatment with either AL or DP. The treatment will be given
supervised at the health centre in the morning and the evening on day 0, day 1, and day 2.
At each visit and in the morning on day 3, the child will be examined, the mother asked for
any symptoms and signs of side-effects, the temperature measured. Furthermore, a blood sample
will be taken for examination of malaria parasites. On day 0 samples for measurement of
antimalarial drugs and for genotyping of the parasites will be taken on filterpaper. In a
subgroup of 50 children a blood sample for in vitro culturing and for analysis of the number
of leucocytes will also be taken.
After having finished the treatment the children will be followed on day 7 and then once a
week until day 42. At each visit the condition of the child will be examined and a
bloodsample taken for examination of parasites in the blood. Furthermore, a filterpaper
bloodsample will be collected for measurement of the drug concentration of if the child has
recrudescence for genotyping of the parasites. On day 0, 3 and 42 the haemoglobin level will
be examined.
The result of the two treatments will be evaluated by comparing the number of children with
recurrent parasitaemia, both corrected and uncorrected (recrudescence vs. reinfections). This
will be presented as adequate clinical and parasitological response rates PCR-corrected and
PCR-uncorrected. Furthermore, the chance in haemoglobin level from day 0 till day 3 and till
day 42 will be compared. The concentration of the antimalarial drug in the blood samples
taken at the visit before the re-parasitaemia will be capered to the concentrations in
children without re-parasitaemia.
Assuming a 20% loss to follow up a total of 346 children should be included. For the children
included, health care and medications at Bandim Health Centre will be free during the study
period but no other gifts or payments will be made.
Results will be presented to the staff at the Bandim health centre and the ministry of Health
and will be published in an international peer reviewed journal.