MalariaPhase 4PAACT-PFNCT01082731
Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Falciparum in Pregnancy in Brazil
A Phase 4 study testing Artemether-Lumefantrine and Mefloquine- Artesunate in people with Malaria, run by Centers for Disease Control and Prevention at 2 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Malaria
- What is being tested?
- Artemether-Lumefantrine and Mefloquine- Artesunate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesBrazil
- Study dates
- Nov 2010to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital Geral Maternidade de Cruzeiro do Sul
Cruzeiro do Sul, Acre
Centro de Pesquisa em Patologias Tropicais
Porto Velho, Rondônia
About this study
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
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
- Being tested
- Artemether-Lumefantrine, Mefloquine- Artesunate
- Keywords
- Malaria, Plasmodium falciparum, Treatment, Brazil
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemether-LumefantrineDrug
Also called Coartem, Lumet
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
Mefloquine- ArtesunateDrug
Also called Mefloquine- Artesunate (Farmaguinhos, Brazil)
Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: Artemether-Lumefantrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
63-day PCR-adjusted parasitological cure of P. falciparum
Measured: 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2012
- Study completionJan 2012
Why it stopped: Extremely slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Meghna Desai, PhD MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082731
- Sponsor's protocol ID
- PAACT-PF
- Acronym
- PAACT-PF
- Status last verified
- Apr 2012
- First submitted
- 8 Mar 2010
- Last updated
- 13 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01082731
- Acronym / sponsor ID
- PAACT-PF / PAACT-PF
- Conditions
- Malaria
- Keywords
- Malaria, Plasmodium falciparum, Treatment, Brazil
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extremely slow enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Nov 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 9 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mefloquine- Artesunate | Experimental | Drug: Mefloquine- ArtesunateMefloquine- Artesunate (Farmaguinhos, Brazil): tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days. |
| Artemether- Lumefantrine | Active comparator | Drug: Artemether-LumefantrineArtemether-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 |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemether-LumefantrineAlso: Coartem, Lumet4 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 |
| Mefloquine- ArtesunateAlso: 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 |
Primary outcome
63-day PCR-adjusted parasitological cure of P. falciparum
Time frame: 63 days
Results and safety
The study was stopped early (reason given: Extremely slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghna Desai, PhD MPH principal investigator
Centers for Disease Control and Prevention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Artemether-Lumefantrine and Mefloquine- Artesunate in people with Malaria, run by Centers for Disease Control and Prevention at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Extremely slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
63-day PCR-adjusted parasitological cure of P. falciparum (time frame: 63 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2012.