Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)

Launched by CENTERS FOR DISEASE CONTROL AND PREVENTION · Apr 19, 2010

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Gestational age \>16 weeks (determined by LMP and fundal height)- if there is discordance between the two, the more conservative estimate (i.e. lower) will be used, to prevent accidental exposure of a 1st trimester fetus
• • Normal fetal heart beat detected by Doppler
• • Presence of asexual P. vivax parasitemia ≤ 50,000 parasites/microliter (thick smear)
• • Willing to sign or thumb print informed consent
• • Willing to return for scheduled follow up visits for treatment and observation until delivery
• • Willing to deliver in health facility
• Exclusion Criteria:
• • Pregnancy \< 16 weeks
• • Microscopically confirmed P. falciparum or mixed infection/ parasitemia (P. vivax and another species of Plasmodium, i.e. P. vivax, P. ovale, or P. malariae)
• • History of allergy or hypersensitivity to interventional drugs
• • Exposure to antimalarial drugs and other drugs with antimalarial activity within the past 2 months, as determined by history from the woman (quinine, mefloquine, or artemisinin derivatives, including AL and MA)
• • Patients taking drugs with possible interaction with study drugs (ie. warfarin, digoxin)
• • History or family history of epilepsy or psychiatric disorder
• • Presence of signs and symptoms of severe malaria, severe illness, or danger signs
• • Hemoglobin \< 7 g/dl
• • Inability to tolerate oral medication (repeated vomiting, impairment of consciousness).
• • History of chronic disease including diabetes, renal failure, hepatic failure, heart disease requiring anti-arrhythmic drugs or warfarin, HIV/ AIDS, known hemoglobinopathy
• • Participant's inability to return for follow up visits
• • Age \<15 years