Malaria Clinical Trial
Official title:
Phase III Study to Study the Clinical Response to ACT Fixed Dose Combination in 42 Days in Uncomplicated Malaria in Cameroon
To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in
comparison with artemether-lumefantrine during 42 days follow up period in 720 children with
acute uncomplicated P. falciparum malaria, in two different endemic ecological areas -
Savanna and equatorial forest regions of Cameroon.
We have set as specific objectives:
- To assess the efficacy of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in
comparison with artemether-lumefantrine during 14 and 28 days follow up period in
children with acute uncomplicated P. falciparum malaria in two different endemic areas.
- To evaluate the safety of artesunate-amodiaquine, dihydroartemisinin-piperaquine, in
comparison with artemether-lumefantrine during 42 days follow up period in children with
acute uncomplicated P. falciparum malaria.
- To determine parasite clearance time (PCT) and fever clearance time (FCT) following the
administration of the three trial regimens.
- To investigate the treatment response based on WHO criteria (WHO, 2003) in patients in
all groups after trial.
- To investigate the Single Nucleotide Polymorphisms (SNPs) and microsatellite markers of
genes associated with drug resistance
Methodology Children of either gender, between 6 months (> 5kg) and 10 years of age, with
acute uncomplicated P. falciparum infection, who fulfil all of the inclusion and have none of
exclusion criteria will be enrolled in the study. They will be randomised to receive the
three trial arms, i.e, Study Arm-A: artesunate-amodiaquine, Study Arm-B:
dihydroartemisinin-piperaquine and Study Arm-C: artemether-lumefantrine at the ratio of 2:2:1
and will be hospitalised over a 3-day period to facilitate the supervised administration of
the study drugs and full clinical and laboratory assessment and observation of early adverse
effects. On discharge, participants will be required to report to the study clinic on days 7,
14, 21,28, 35 and 42 or at any other time when clinical sign(s)/symptom(s) of malaria is
suspected. The number of participants is about 720 children
Inclusion Criteria
- Children of either gender, aged between 6 months (> 5kg) and 10 years.
- Suffering from acute uncomplicated P. falciparum malaria confirmed by microscopy using
Giemsa-stained thick film with an asexual parasite density of 1,000 to 100,000
parasites/μl.
- Presenting with fever (axillary temperature ≥ 37.5oC) or having a history of fever in
the preceding 24 hours.
- Able to ingest tablets orally (either suspended in water or uncrushed with food).
- Willing to participate in the study with written assent from parent/guardian. Parental
authorization will be obtained for children less than 8 years old and documented assent
of parents/guardians for children 8-10 years.
- Willing and able to attend the clinic on stipulated regular follow-up visits.
Exclusion Criteria
• Any of the following "danger signs of severe malaria": Not able to drink or breast feed
Persistent vomiting (>2 episodes within previous 24 hours) Convulsions (>1 episode within
previous 24 hours) Lethargic/unconscious
- Signs/symptoms indicating severe/complicated malaria according to WHO criteria (WHO
definition).
- Concomitant illnesses, underlying chronic hepatic or renal disease, abnormal cardiac
rhythm, hypoglycaemia, jaundice, respiratory distress,
- Serious gastrointestinal disease, severe malnutrition (W/H < 70%) or severe anaemia
(haemoglobin < 5 g/dl).
- Known hypersensitivity to the study drugs.
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