Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)
Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Plasmodium Vivax Malaria
Intervention: Mefloquine- Artesunate (Drug); Artemether-Lumefantrine (Drug); Chloroquine (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s): Meghna Desai, MPH PhD, Principal Investigator, Affiliation: Centers for Disease Control and Prevention
Summary
The current treatment recommendations for P. vivax in pregnant and non-pregnant individuals
are to use chloroquine; in non-pregnant patients this is followed by primaquine to prevent
relapse. As primaquine can not be used in pregnant women, these women remain at risk of
relapse. As there is increasing concern about chloroquine resistant P. vivax in this
region, there is a need to identify alternative treatment options. The artemisinin
combination therapies are recommended for use against P. falciparum infections in pregnant
women after the 1st trimester; additional data are needed to support the use of these drugs
against P. vivax.
Clinical Details
Official title: A Multi-center, Open-label, Randomized Trial of Chloroquine, Artemether-Lumefantrine, and Mefloquine-Artesunate for the Treatment of Uncomplicated P. Vivax Malaria in Pregnant Women in Brazil
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 63-day PCR-adjusted parasitological cure of P. vivax
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Hospital Geral Maternidade de Cruzeiro do Sul, Cruzeiro do Sul, Acre, Brazil
Hospital Municipal Teonila Alves, Anajas, Para, Brazil
Centro de Pesquisa em Patologias Tropicais, Porto Velho, Rondonia, Brazil
Additional Information
Starting date: February 2011
Last updated: April 12, 2012
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