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

Sponsor

Centers for Disease Control and Prevention (U.S. Fed)

Overall Status

Terminated

CT.gov ID

NCT01082731

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Artemether-Lumefantrine Drug: Mefloquine- Artesunate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mefloquine- Artesunate Mefloquine- Artesunate (Farmaguinhos, Brazil): tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.	Drug: Mefloquine- Artesunate Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days. Other Names: Mefloquine- Artesunate (Farmaguinhos, Brazil)
Active Comparator: Artemether- Lumefantrine 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	Drug: 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 Other Names: Coartem Lumet

Arm

Intervention/Treatment

Experimental: Mefloquine- Artesunate

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

Drug: Mefloquine- Artesunate

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

Other Names:

Mefloquine- Artesunate (Farmaguinhos, Brazil)

Active Comparator: Artemether- Lumefantrine

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

Drug: 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

Other Names:

Coartem

Lumet

Outcome Measures

Primary Outcome Measures

63-day PCR-adjusted parasitological cure of P. falciparum [63 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years and Older

Sexes Eligible for Study:

Female

Accepts 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