Plasmodium Vivax MalariaPhase 4PAACT-PVNCT01107145
Efficacy of Artemisinin Combination Therapies for the Treatment of Uncomplicated P. Vivax in Pregnancy in Brazil (PAACT-PV)
A Phase 4 study testing Mefloquine- Artesunate, Artemether-Lumefantrine and Chloroquine in people with Plasmodium Vivax Malaria, run by Centers for Disease Control and Prevention at 3 sites in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Plasmodium Vivax Malaria
- What is being tested?
- Mefloquine- Artesunate, Artemether-Lumefantrine and Chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesBrazil
- Study dates
- Feb 2011to 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 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Brazil3 sites
Hospital Municipal Teonila Alves
Anajás, Pará
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 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.
- Conditions
- Plasmodium Vivax Malaria
- Being tested
- Mefloquine- Artesunate, Artemether-Lumefantrine, Chloroquine
- Keywords
- Plasmodium, Vivax, Malaria, Pregnancy, Brazil, Treatment
- Medical subject headings
- Malaria, Vivax, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mefloquine- ArtesunateDrug
Also called Artesunato-Mefloquina (Farmaguinhos, Brazil)
Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
Artemether-LumefantrineDrug
Also called Coartem, Novartis, 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
ChloroquineDrug
Also called 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)
| 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 | Experimental | 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 Receives: Drug: Artemether-Lumefantrine |
| Chloroquine | Active comparator | 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) Receives: Drug: Chloroquine |
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. vivax
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 posted20 Apr 2010 (estimated)
- Study startFeb 2011
- 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 Plasmodium Vivax 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Meghna Desai, MPH PhD, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107145
- Sponsor's protocol ID
- PAACT-PV
- Acronym
- PAACT-PV
- Status last verified
- Apr 2012
- First submitted
- 19 Apr 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 Trial of Chloroquine, Artemether-Lumefantrine, and Mefloquine-Artesunate for the Treatment of Uncomplicated P. Vivax Malaria in Pregnant Women in Brazil
- ClinicalTrials.gov ID
- NCT01107145
- Acronym / sponsor ID
- PAACT-PV / PAACT-PV
- Conditions
- Plasmodium Vivax Malaria
- Keywords
- Plasmodium, Vivax, Malaria, Pregnancy, Brazil, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Extremely slow enrollment
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 20 Apr 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| 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 | Experimental | Drug: Artemether-LumefantrineArtemether-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 |
| Chloroquine | Active comparator | Drug: ChloroquineChloroquine (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) |
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 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
Key exclusion criteria (12 listed)
- 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)
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 |
|---|---|---|
| Mefloquine- ArtesunateAlso: Artesunato-Mefloquina (Farmaguinhos, Brazil)Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days. | Drug | Mefloquine- Artesunate |
| Artemether-LumefantrineAlso: Coartem, Novartis, Lumet, Cipla4 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 |
| ChloroquineAlso: 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) | Drug | Chloroquine |
Primary outcome
63-day PCR-adjusted parasitological cure of P. vivax
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, MPH PhD principal investigator
Centers for Disease Control and Prevention
3 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 Mefloquine- Artesunate, Artemether-Lumefantrine and Chloroquine in people with Plasmodium Vivax Malaria, run by Centers for Disease Control and Prevention at 3 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 3 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. vivax (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.