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

Primary Purpose

Plasmodium Vivax Malaria

Status
Terminated
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Mefloquine- Artesunate
Artemether-Lumefantrine
Chloroquine
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plasmodium Vivax Malaria focused on measuring Plasmodium, Vivax, Malaria, Pregnancy, Brazil, Treatment

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Geral Maternidade de Cruzeiro do Sul
  • Hospital Municipal Teonila Alves
  • Centro de Pesquisa em Patologias Tropicais

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Mefloquine- Artesunate

Artemether-Lumefantrine

Chloroquine

Arm Description

Mefloquine- Artesunate (Farmaguinhos, Brazil): tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.

Artemether-Lumefantrine, Lumet, Cipla 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 (Farmaguinhos, Brazil): 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)

Outcomes

Primary Outcome Measures

63-day PCR-adjusted parasitological cure of P. vivax

Secondary Outcome Measures

Full Information

First Posted
April 19, 2010
Last Updated
April 12, 2012
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT01107145
Brief Title
Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)
Acronym
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
Extremely slow enrollment
Study Start Date
February 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasmodium Vivax Malaria
Keywords
Plasmodium, Vivax, Malaria, Pregnancy, Brazil, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mefloquine- Artesunate
Arm Type
Experimental
Arm Description
Mefloquine- Artesunate (Farmaguinhos, Brazil): tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
Arm Title
Artemether-Lumefantrine
Arm Type
Experimental
Arm Description
Artemether-Lumefantrine, Lumet, Cipla 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
Arm Title
Chloroquine
Arm Type
Active Comparator
Arm Description
Chloroquine (Farmaguinhos, Brazil): 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)
Intervention Type
Drug
Intervention Name(s)
Mefloquine- Artesunate
Other Intervention Name(s)
Artesunato-Mefloquina (Farmaguinhos, Brazil)
Intervention Description
Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
Intervention Type
Drug
Intervention Name(s)
Artemether-Lumefantrine
Other Intervention Name(s)
Coartem, Novartis, Lumet, Cipla
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Other Intervention Name(s)
Chloroquine (Farmaguinhos, Brazil)
Intervention Description
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)
Primary Outcome Measure Information:
Title
63-day PCR-adjusted parasitological cure of P. vivax
Time Frame
63 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meghna Desai, MPH PhD
Organizational Affiliation
Centers for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Geral Maternidade de Cruzeiro do Sul
City
Cruzeiro do Sul
State/Province
Acre
Country
Brazil
Facility Name
Hospital Municipal Teonila Alves
City
Anajas
State/Province
Para
Country
Brazil
Facility Name
Centro de Pesquisa em Patologias Tropicais
City
Porto Velho
State/Province
Rondonia
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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