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

Plasmodium Vivax Malaria Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01107145
• Other study ID #: PAACT-PV
• Status: Terminated
• Phase: Phase 4
• First received: April 19, 2010
• Last updated: April 12, 2012
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review BoardBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Malaria, Vivax
• Plasmodium Vivax Malaria

Intervention

Drug:
• Mefloquine- Artesunate
Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
• Artemether-Lumefantrine
4 tablets containing 20 mg of artemether plus 120 mg of lumefantrine per tablet twice daily for three days as 2 doses 8 hours apart on the 1st day and then 2 doses 12 hours apart on the 2nd and 3rd days, administered with a fatty meal
• Chloroquine
Tablets containing 250 mg Chloroquine salt given as 4 tablets at once on the first day (or 10 mg/kg) followed by 3 tablets once daily for the next 2 days (or 7,5 mg/kg)

Locations

Country	Name	City	State
Brazil	Hospital Municipal Teonila Alves	Anajas	Para
Brazil	Hospital Geral Maternidade de Cruzeiro do Sul	Cruzeiro do Sul	Acre
Brazil	Centro de Pesquisa em Patologias Tropicais	Porto Velho	Rondonia

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	63-day PCR-adjusted parasitological cure of P. vivax		63 days	No