Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Falciparum in Pregnancy in Brazil
Information source: Centers for Disease Control and Prevention
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malaria
Intervention: Artemether-Lumefantrine (Drug); Mefloquine- Artesunate (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Centers for Disease Control and Prevention Official(s) and/or principal investigator(s):
Meghna Desai, PhD MPH, Principal Investigator, Affiliation: Centers for Disease Control and Prevention
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 63-day PCR-adjusted parasitological cure of P. falciparum
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Hospital Geral Maternidade de Cruzeiro do Sul, Cruzeiro do Sul, Acre, Brazil
Centro de Pesquisa em Patologias Tropicais, Porto Velho, Rondonia, Brazil
Additional Information
Starting date: November 2010
Last updated: April 12, 2012
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