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

NCT ID: NCT01082731

Last Updated: 2012-04-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-01-31

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.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mefloquine- Artesunate

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

Group Type: EXPERIMENTAL

Mefloquine- Artesunate

Intervention Type: DRUG

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

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

Group Type: ACTIVE_COMPARATOR

Artemether-Lumefantrine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Mefloquine- Artesunate

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

Intervention Type: DRUG

Other Intervention Names

Coartem; Lumet; Mefloquine- Artesunate (Farmaguinhos, Brazil)

Eligibility Criteria

Inclusion Criteria

1. 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

2. Normal fetal heart beat detected by Doppler

3. Presence of any P. falciparum parasitemia ≤ 50,000 parasites/microliter (thick film)

4. Willing to sign or thumb print informed consent

5. Willing to return for scheduled follow up visits for treatment and observation until delivery

6. Willing to deliver in health facility

Exclusion Criteria

1. Pregnancy < 16 weeks

2. Microscopically confirmed P. vivax or mixed infection/ parasitemia (P. falciparum and another species of Plasmodium, i.e. P. vivax, P. ovale, or P. malariae)

3. History of allergy or hypersensitivity to interventional drugs

4. 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)

5. Patients taking drugs with possible interaction with study drugs (ie. warfarin, digoxin)

6. History or family history of epilepsy or psychiatric disorder

7. Presence of signs and symptoms of severe malaria

8. Hemoglobin < 7 g/dl

9. Inability to tolerate oral medication (repeated vomiting, impairment of consciousness).

10. History of chronic disease including diabetes, renal failure, hepatic failure, heart disease requiring anti-arrhythmic drugs or warfarin, HIV or AIDS, known hemoglobinopathy

11. Participant's inability to return for follow up visits

12. Age <15 years

• Minimum Eligible Age: 15 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meghna Desai, PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Centers for Disease Control and Prevention

Locations

Hospital Geral Maternidade de Cruzeiro do Sul

Cruzeiro do Sul, Acre, Brazil

Centro de Pesquisa em Patologias Tropicais

Porto Velho, Rondônia, Brazil

Countries

Brazil

Other Identifiers

PAACT-PF

Identifier Type: -

Identifier Source: org_study_id