Plasmodium Falciparum MalariaNCT01659281
Efficacy of Artesunate-Mefloquine Combination Therapy in Trat Province, Thailand
A study testing Artesunate and Mefloquine in people with Plasmodium Falciparum Malaria, run by Armed Forces Research Institute of Medical Sciences, Thailand at 1 site in Thailand.
Trial summary
The main purpose of this study is to compare artesunate-mefloquine combination therapy given for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum malaria. Read more about this study
- Who is it for?
- Ages 5 to 70 years
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- Artesunate and Mefloquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2007to May 2012
- Phase
- Interventional
- 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 5 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 5 to 70 years inclusive. If aged < 18 years the subject must have a parent or guardian in attendance.
- Asexual stages of P. falciparum parasites in a thick or thin blood film with no other visible plasmodial species.
- Willing to give informed consent. Parents or guardians of children and adolescents must agree to give informed consent. Assent is necessary in addition to parental informed consent.
- Able to tolerate oral therapy.
- Willing to attend follow-up appointments and undergo study procedures.
Who cannot join
- History of anti-malarial drug use within the past two weeks or mefloquine (MQ) use within 4 weeks.
- Bleeding tendency (by history or based on medical records).
- Severe/complicated malaria as determined by the investigator (coma or seizures, pulmonary edema, shock, renal failure, jaundice, severe anemia, spontaneous bleeding, hyperparasitemia (>5% RBCs infected), or prostration).
- History of allergy to or intolerance of study medications.
- Mixed malaria infection by Giemsa stain.
- Any other condition that in the opinion of the study investigator warrants parenteral antimalarial treatment.
- Pregnant woman or nursing mother
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Vector Borne Diseases Control Units (VBDC, malaria clinics)
Borai, Khaosaming and Muang Districts, Changwat Trat, 23000
About this study
Official title: Efficacy of Artesunate-Mefloquine Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Trat Province, Thailand
The main purpose of this study is to compare artesunate-mefloquine combination therapy given for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum malaria.
Read the detailed description
This will be a randomized, open-label comparison of two versus three days artesunate-mefloquine treatment in patients with uncomplicated falciparum malaria. Primary endpoints will be 63-day parasitological cure rates in the 2 treatment groups. Secondary endpoints will be parasitological failure rates at each of the weekly follow-up visits to Day 56, occurence of treatment-emergent adverse events on days 0, 1 and 2, mefloquine blood concentrations on days 7, 14 and 28, and in vitro drug sensitivity profiles for parasite isolates as measured by inhibitory concentrations. Genotyping of parasites for known markers of drug resistence will be performed.
- Conditions
- Plasmodium Falciparum Malaria
- Being tested
- Artesunate, Mefloquine
- Keywords
- Artesunate, Mefloquine, Plasmodium Falciparum, Thailand, Uncomplicated Plasmodium Falciparum malaria
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtesunateDrug
6 mg/kg/day for 2 days (total dose 12 mg/kg)
ArtesunateDrug
4 mg/kg/day for 3 days
MefloquineDrug
15mg/kg at T=0 and 10 mg/kg 6-24 hours later
MefloquineDrug
8 mg/kg daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 2-day oral treatment with: Artesunate 6mg/kg at 0 and 24 hours Mefloquine 25 mg/kg total dose split into 2 doses of 15 mg/kg at 0 hours and and 10 mg/kg given 6-24 hours later Primaquine 0.5 mg/kg single dose at 24 hours Receives: Drug: Artesunate; Drug: Mefloquine |
| 2 | Active comparator | 3 days oral treatment with: Artesunate 4 mg/kg/day for 3 days Mefloquine 8 mg/kg/day for 3 days Primaquine 0.5 mg/kg single dose at 24 hours Receives: Drug: Artesunate; Drug: Mefloquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of parasitological cure rate of directly observed antimalarial therapy
Measured: 63 days from initiation of treatment
Secondary outcomes (4)
Parasitological cure rates
Measured: Weekly to Day 56
Occurence of treatment-emergent adverse events
Measured: 3 days
In vitro drug sensitivity profile for individual parasite isolates
Measured: Baseline
Mefloquine whole blood concentrations
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2012 (estimated)
- Study startSep 2007
- Primary completionMay 2008
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Research Institute of Medical Sciences, Thailand
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Douglas Walsh, Armed Forces Research Institute of Medical Sciences, Thailand
- Investigators
- Wichai - Satimai, M.D., D.T.M. & H., Principal investigator, Bureau of Vector-Borne Disease, Department of Disease Control, Ministry of Public HealthMark M. Fukuda, M.D., Principal investigator, Dept. of Immunology and Medicine, AFRIMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01659281
- Sponsor's protocol ID
- WRAIR-1327
- Status last verified
- Aug 2012
- First submitted
- 26 Jan 2011
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Artesunate-Mefloquine Combination Therapy for the Treatment of Uncomplicated Falciparum Malaria in Trat Province, Thailand
- ClinicalTrials.gov ID
- NCT01659281
- Acronym / sponsor ID
- WRAIR-1327
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- Artesunate, Mefloquine, Plasmodium Falciparum, Thailand, Uncomplicated Plasmodium Falciparum malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Armed Forces Research Institute of Medical Sciences, ThailandOther government
- Study start
- Sep 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 7 Aug 2012 (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 main purpose of this study is to compare artesunate-mefloquine combination therapy given for 2 and 3 days at the same total dose for the treatment of uncomplicated falciparum malaria.
Detailed description
This will be a randomized, open-label comparison of two versus three days artesunate-mefloquine treatment in patients with uncomplicated falciparum malaria. Primary endpoints will be 63-day parasitological cure rates in the 2 treatment groups. Secondary endpoints will be parasitological failure rates at each of the weekly follow-up visits to Day 56, occurence of treatment-emergent adverse events on days 0, 1 and 2, mefloquine blood concentrations on days 7, 14 and 28, and in vitro drug sensitivity profiles for parasite isolates as measured by inhibitory concentrations. Genotyping of parasites for known markers of drug resistence will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Artesunate, Drug: Mefloquine2-day oral treatment with: Artesunate 6mg/kg at 0 and 24 hours Mefloquine 25 mg/kg total dose split into 2 doses of 15 mg/kg at 0 hours and and 10 mg/kg given 6-24 hours later Primaquine 0.5 mg/kg single dose at 24 hours |
| 2 | Active comparator | Drug: Artesunate, Drug: Mefloquine3 days oral treatment with: Artesunate 4 mg/kg/day for 3 days Mefloquine 8 mg/kg/day for 3 days Primaquine 0.5 mg/kg single dose at 24 hours |
Who may qualify
- Ages
- 5 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 5 to 70 years inclusive. If aged < 18 years the subject must have a parent or guardian in attendance.
- Asexual stages of P. falciparum parasites in a thick or thin blood film with no other visible plasmodial species.
- Willing to give informed consent. Parents or guardians of children and adolescents must agree to give informed consent. Assent is necessary in addition to parental informed consent.
- Able to tolerate oral therapy.
- Willing to attend follow-up appointments and undergo study procedures.
Key exclusion criteria (7 listed)
- History of anti-malarial drug use within the past two weeks or mefloquine (MQ) use within 4 weeks.
- Bleeding tendency (by history or based on medical records).
- Severe/complicated malaria as determined by the investigator (coma or seizures, pulmonary edema, shock, renal failure, jaundice, severe anemia, spontaneous bleeding, hyperparasitemia (>5% RBCs infected), or prostration).
- History of allergy to or intolerance of study medications.
- Mixed malaria infection by Giemsa stain.
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 |
|---|---|---|
| Artesunate6 mg/kg/day for 2 days (total dose 12 mg/kg) | Drug | 1 |
| Artesunate4 mg/kg/day for 3 days | Drug | 2 |
| Mefloquine15mg/kg at T=0 and 10 mg/kg 6-24 hours later | Drug | 1 |
| Mefloquine8 mg/kg daily for 3 days | Drug | 2 |
Primary outcome
Determination of parasitological cure rate of directly observed antimalarial therapy
Time frame: 63 days from initiation of treatment
4 secondary outcomes
Parasitological cure rates
Time frame: Weekly to Day 56
Occurence of treatment-emergent adverse events
Time frame: 3 days
In vitro drug sensitivity profile for individual parasite isolates
Time frame: Baseline
Mefloquine whole blood concentrations
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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.
Wichai - Satimai, M.D., D.T.M. & H. principal investigator
Bureau of Vector-Borne Disease, Department of Disease Control, Ministry of Public Health
Mark M. Fukuda, M.D. principal investigator
Dept. of Immunology and Medicine, AFRIMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artesunate and Mefloquine in people with Plasmodium Falciparum Malaria, run by Armed Forces Research Institute of Medical Sciences, Thailand at 1 site in Thailand.
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 5 inclusion and 7 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: finished, as of the sponsor's last update on 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of parasitological cure rate of directly observed antimalarial therapy (time frame: 63 days from initiation of treatment). 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 7 Aug 2012.