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

NCT01082731 | Terminated Phase 4 DMC

• 1 other identifier: PAACT-PF
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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

Keywords

Malaria; Plasmodium falciparum; Treatment; Brazil

Outcome Measures

Primary Outcomes (1)

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

  63 days

Study Arms (2)

Mefloquine- Artesunate

EXPERIMENTAL

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

Artemether- Lumefantrine

ACTIVE COMPARATOR

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

Interventions

Artemether-Lumefantrine 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

Also known as: Coartem, Lumet

Artemether- Lumefantrine

Mefloquine- Artesunate DRUG

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

Also known as: Mefloquine- Artesunate (Farmaguinhos, Brazil)

Mefloquine- Artesunate

Eligibility Criteria

• Age: 15 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centers for Disease Control and Prevention: lead

Study Sites (2)

Hospital Geral Maternidade de Cruzeiro do Sul

Cruzeiro do Sul, Acre, Brazil

Location

Centro de Pesquisa em Patologias Tropicais

Porto Velho, Rondônia, Brazil

Location

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Artemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Artemether; Artemisinins; Reactive Oxygen Species; Free Radicals; Inorganic Chemicals; Organic Chemicals; Lumefantrine; Fluorenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sesquiterpenes; Terpenes; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Meghna Desai, PhD MPH

  Centers for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 9, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 13, 2012

Record last verified: 2012-04

Locations

BR (2)