- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01107145
Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV) (PAACT-PV)
April 12, 2012 updated by: Centers for Disease Control and Prevention
A Multi-center, Open-label, Randomized Trial of Chloroquine, Artemether-Lumefantrine, and Mefloquine-Artesunate for the Treatment of Uncomplicated P. Vivax Malaria in Pregnant Women in Brazil
The current treatment recommendations for P. vivax in pregnant and non-pregnant individuals are to use chloroquine; in non-pregnant patients this is followed by primaquine to prevent relapse.
As primaquine can not be used in pregnant women, these women remain at risk of relapse.
As there is increasing concern about chloroquine resistant P. vivax in this region, there is a need to identify alternative treatment options.
The artemisinin combination therapies are recommended for use against P. falciparum infections in pregnant women after the 1st trimester; additional data are needed to support the use of these drugs against P. vivax.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Acre
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Cruzeiro do Sul, Acre, Brazil
- Hospital Geral Maternidade de Cruzeiro do Sul
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Para
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Anajas, Para, Brazil
- Hospital Municipal Teonila Alves
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Rondonia
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Porto Velho, Rondonia, Brazil
- Centro de Pesquisa em Patologias Tropicais
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 asexual P. vivax parasitemia ≤ 50,000 parasites/microliter (thick smear)
- 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. falciparum or mixed infection/ parasitemia (P. vivax 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, severe illness, or danger signs
- 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/ AIDS, known hemoglobinopathy
- Participant's inability to return for follow up visits
- Age <15 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / 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.
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Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
Other Names:
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EXPERIMENTAL: Artemether-Lumefantrine
Artemether-Lumefantrine, Lumet, Cipla 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
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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:
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ACTIVE_COMPARATOR: Chloroquine
Chloroquine (Farmaguinhos, Brazil): Tablets containing 250 mg Chloroquine salt given as 4 tablets at once on the first day (or 10 mg/kg) followed by 3 tablets once daily for the next 2 days (or 7,5 mg/kg)
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Tablets containing 250 mg Chloroquine salt given as 4 tablets at once on the first day (or 10 mg/kg) followed by 3 tablets once daily for the next 2 days (or 7,5 mg/kg)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
63-day PCR-adjusted parasitological cure of P. vivax
Time Frame: 63 days
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63 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (ACTUAL)
January 1, 2012
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
April 19, 2010
First Submitted That Met QC Criteria
April 19, 2010
First Posted (ESTIMATE)
April 20, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
April 13, 2012
Last Update Submitted That Met QC Criteria
April 12, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Vector Borne Diseases
- Parasitic Diseases
- Protozoan Infections
- Malaria
- Malaria, Vivax
- Physiological Effects of Drugs
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Antiviral Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Amebicides
- Filaricides
- Antinematodal Agents
- Anthelmintics
- Schistosomicides
- Antiplatyhelmintic Agents
- Chloroquine
- Chloroquine diphosphate
- Lumefantrine
- Artemether
- Artesunate
- Artemether, Lumefantrine Drug Combination
- Mefloquine
Other Study ID Numbers
- PAACT-PV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Mefloquine- Artesunate
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Institute of Tropical Medicine, BelgiumLiverpool School of Tropical Medicine; Centre MurazCompletedPlasmodium Falciparum MalariaBurkina Faso