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

Primary Purpose

Malaria

Status

Terminated

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Artemether-Lumefantrine

Mefloquine- Artesunate

About this trial

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

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 any P. falciparum parasitemia ≤ 50,000 parasites/microliter (thick film)
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. vivax or mixed infection/ parasitemia (P. falciparum 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
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 or AIDS, known hemoglobinopathy
Participant's inability to return for follow up visits
Age <15 years

Sites / Locations

Hospital Geral Maternidade de Cruzeiro do Sul
Centro de Pesquisa em Patologias Tropicais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mefloquine- Artesunate

Artemether- Lumefantrine

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: 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01082731

First Posted

March 8, 2010

Last Updated

April 12, 2012

Sponsor

Centers for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT01082731

Brief Title

Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Falciparum in Pregnancy in Brazil

Acronym

PAACT-PF

Official Title

A Multi-center, Open-label, Randomized, Phase 4, Trial of Artemether-Lumefantrine and Mefloquine-Artesunate for the Treatment of Uncomplicated P. Falciparum Malaria Parasitemia 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

November 2010 (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

Data on the burden of MIP in low transmission areas, such as Latin America, are very limited; there is even less information on the efficacy of case management of MiP. The treatment recommendations for MiP in Latin American countries have been changing rapidly in recent months; currently, either artemether-lumefantrine (AL) or mefloquine-artesunate (MA) is the first line treatment for P. falciparum (depending on country); however, no data exists on the efficacy of these drugs for the treatment of malaria in pregnancy in Latin America to support their use. We propose a multi-center 2-arm open-label randomized Phase 4 clinical trial to assess safety and efficacy of the present therapies, AL and MA. We hypothesize that the drugs will both be efficacious for use in pregnant women in Brazil.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria

Keywords

Malaria, Plasmodium falciparum, Treatment, Brazil

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

6 (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

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Artemether-Lumefantrine

Other Intervention Name(s)

Coartem, Lumet

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)

Mefloquine- Artesunate

Other Intervention Name(s)

Mefloquine- Artesunate (Farmaguinhos, Brazil)

Intervention Description

Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.

Primary Outcome Measure Information:

Title

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

Time Frame

63 days

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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 any P. falciparum parasitemia ≤ 50,000 parasites/microliter (thick film) 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. vivax or mixed infection/ parasitemia (P. falciparum 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 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 or 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, PhD MPH

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

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. Falciparum in Pregnancy in Brazil

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