Clinical trial NCT01107145: Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Plasmodium Vivax Malaria
Keywords: Plasmodium
Vivax
Malaria
Pregnancy
Brazil
Treatment
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2010-04-20
Enrollment: 16
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: 63-day PCR-adjusted parasitological cure of P. vivax
timeFrame: 63 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cruzeiro do Sul
country: Brazil
facility: Hospital Geral Maternidade de Cruzeiro do Sul
state: Acre
city: Anajas
country: Brazil
facility: Hospital Municipal Teonila Alves
state: Para
city: Porto Velho
country: Brazil
facility: Centro de Pesquisa em Patologias Tropicais
state: Rondonia
Study officials:
affiliation: Centers for Disease Control and Prevention
name: Meghna Desai, MPH PhD
role: PRINCIPAL_INVESTIGATOR
References: