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

This study has been terminated.
(Extremely slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01082731
First received: March 8, 2010
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Malaria
 Drug: Artemether-Lumefantrine
Drug: Mefloquine- Artesunate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Malaria
U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 63-day PCR-adjusted parasitological cure of P. falciparum [ Time Frame: 63 days ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: November 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082731

Locations
Brazil
Hospital Geral Maternidade de Cruzeiro do Sul
Cruzeiro do Sul, Acre, Brazil
Centro de Pesquisa em Patologias Tropicais
Porto Velho, Rondonia, Brazil
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
Principal Investigator: Meghna Desai, PhD MPH Centers for Disease Control and Prevention
  More Information

No publications provided

Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01082731     History of Changes
Other Study ID Numbers: PAACT-PF
Study First Received: March 8, 2010
Last Updated: April 12, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Centers for Disease Control and Prevention:
Malaria
Plasmodium falciparum
Treatment
Brazil

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Mefloquine
Artemether
Artemisinins
Artesunate
Lumefantrine
Artemether-lumefantrine combination
Antimalarials
Antiprotozoal Agents
 Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Coccidiostats
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Amebicides

ClinicalTrials.gov processed this record on May 19, 2013