P. Falciparum MalariaRDMNCT01640587
Compare the Effectiveness Between Existing Treatment and New Treatment
A study testing Mefloquine+Artesunate and Dihydroartemisinin-Piperaquine in people with P. Falciparum Malaria, run by University of Oxford at 1 site in Thailand.
Trial summary
In camps for displaced persons located along the Thai-Myanmar border, mefloquine and artesunate combination therapy has been used since 1992. In vivo efficacy of a 3 day regimen of mefloquine + artesunate (MAS3) has been monitored regularly since its introduction in 1992. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- P. Falciparum Malaria
- What is being tested?
- Mefloquine+Artesunate and Dihydroartemisinin-Piperaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2013to 30 Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 5 years
- Symptomatic of malaria infection, i.e. history of fever or presence of fever >37.5°c.
- microscopically confirmed asexual stages of Plasmodium falciparum ≥ 5/500 wbc (may be mixed with non- P.falciparum species) .
- Written informed consent given to participate in the trial.
- Participant or parent/guardian is willing and able to give informed consent for participation in the study.
- Participant or guardian is able to understand and participant can complete the study requirements
Who cannot join
- Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age unless menstruating).
- P.falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175 000/µL).
- Signs or symptoms indicative of severe malaria:
- Impaired consciousness
- Severe anaemia (Hct<15%)
- Bleeding disorder -evidenced by epistaxis, bleeding gums, frank haematuria, bleeding from venepuncture sites.
Show all 12Show fewer
- Respiratory distress
- Severe jaundice
- Patients who received any P. falciparum treatment within 2 months
- Known hypersensitivity to artemisinins - defined as history of erythroderma/ other severe cutaneous reaction, angioedema or anaphylaxis.
- History of epilepsy and other neurological disorders
- Splenectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Open-label Trial of Comparison Between DHA-Piperaquine and Mefloquine Artesunate Combinations 3 Day-regimens for the Treatment of Uncomplicated Plasmodium Falciparum Malaria on the Thai-Myanmar Border (RDM)
In camps for displaced persons located along the Thai-Myanmar border, mefloquine and artesunate combination therapy has been used since 1992. In vivo efficacy of a 3 day regimen of mefloquine + artesunate (MAS3) has been monitored regularly since its introduction in 1992. In 2009 Carrara et al summarised the in vivo PCR-adjusted cure rates at Day 42 and Day 63 in patients treated with MAS3 between 1995 and 2005, as well as the in-vitro parasite susceptibility to MAS3 during that same period, and the changes in pfmdr1 copy numbers.The proportion of patients with parasitaemia persisting on day-2 increased significantly from 4.5% before 2001 to 21.9% after 2002 (p<0.001). Delayed parasite clearance was associated with increased risk of developing gametocytaemia (AOR = 2.29; 95% CI, 2.00-2.69, p = 0.002). MAS3 efficacy declined slightly but significantly (Hazards ratio 1.13; 95% CI, 1.07-1.19, p<0.001), although efficacy in 2007 remained well within acceptable limits: 96.5% (95% CI, 91.0-98.7). The proportion of infections caused by parasites with increased pfmdr1 copy number rose from 30% (12/40) in 1996 to 53% (24/45) in 2006 (p = 0.012, test for trend).
Evidence of reduced susceptibility to artemisinins in Western Cambodia was first reported in January 2007. Artemisinin resistance was manifest by a marked slowing of parasite clearance. A more recent analysis of parasite clearance data collected prospectively in patients with uncomplicated hyperparasitaemic malaria has shown a progressive decline in parasite clearance rates over the last decade suggesting a decline following the same trajectory as in Western Cambodia but with a time lag of a few years.
Read more
Surveillance data collected in 2011 have shown a dramatic and worrying decline in efficacy of MAS3, albeit in a small number of patients. This decline in efficacy of mefloquine + artesunate is likely to be attributable to reduced parasite susceptibility to mefloquine. The other fixed dose combinations available dihydroartemisinin-piperaquine (DP) is the best option to replace mefloquine-artesunate since it is thought that it remains effective in the presence of high pfmdr1 copy numbers. In addition DP is administered once daily and needs no special dietary modification to ensure adequate absorption.
In this study it is hypothesised that efficacy of DP (estimated to be 95%) will be significantly higher than that of MAS3 (estimated to be 65%), therefore the investigators propose to conduct a randomised controlled trial between DP and MAS3 for the treatment of P.falciparum.
Read the detailed description
In camps for displaced persons located along the Thai-Myanmar border, mefloquine and artesunate combination therapy has been used since 1992. It was studied first in trials, but by 1994 it became the first line treatment for all uncomplicated P. falciparum malaria episodes in the non-pregnant population. In vivo efficacy of a 3 day regimen of mefloquine+ artesunate (MAS3) has been monitored regularly since its introduction in 1992. In 2009 Carrara et al summarised the in vivo PCR-adjusted cure rates at Day 42 and Day 63 in patients treated with MAS3 between 1995 and 2005, as well as the in-vitro parasite susceptibility to MAS3 during that same period, and the changes in pfmdr1 copy numbers.The proportion of patients with parasitaemia persisting on day-2 increased significantly from 4.5% before 2001 to 21.9% after 2002 (p<0.001). Delayed parasite clearance was associated with increased risk of developing gametocytaemia (AOR = 2.29; 95% CI, 2.00-2.69, p = 0.002). MAS3 efficacy declined slightly but significantly (Hazards ratio 1.13; 95% CI, 1.07-1.19, p<0.001), although efficacy in 2007 remained well within acceptable limits: 96.5% (95% CI, 91.0-98.7). The proportion of infections caused by parasites with increased pfmdr1 copy number rose from 30% (12/40) in 1996 to 53% (24/45) in 2006 (p = 0.012, test for trend).
Evidence of reduced susceptibility to artemisinins in Western Cambodia was first reported in January 2007. Artemisinin resistance was manifest by a marked slowing of parasite clearance. In Pailin, Cambodia, the median parasite clearance time was 84 hours compared to 48 hours on the Thai side of the international border with Myanmar following either 2 mg/kg of artesunate (AS) alone for 7 days or 4 mg/kg AS for 3 days plus 25 mg/kg of mefloquine at both locations. A more recent analysis of parasite clearance data collected prospectively in patients with uncomplicated hyperparasitaemic malaria has shown a progressive decline in parasite clearance rates over the last decade suggesting a decline following the same trajectory as in Western Cambodia but with a time lag of a few years.
Clinic experience data collected in 2011 have shown a steady decline in efficacy of MAS3, albeit in a small number of patients. We have observed this trend over the past 10 years. It appears to be related to the increased copies of the gene Pfmdr1 in adult males. The PCR corrected efficacy in 43 patients was 47.0% (95% CI 27.0-64.7), well below the 90% threshold at which WHO recommends changing to an alternative treatment. This decline in efficacy of mefloquine + artesunate is likely to be attributable to reduced parasite susceptibility to mefloquine. The other fixed dose combinations available dihydroartemisinin-piperaquine (DP) is the best option to replace mefloquine-artesunate since it is thought that it remains effective in the presence of high pfmdr1 copy numbers. In addition DP is administered once daily and needs no special dietary modification to ensure adequate absorption.
However other groups in the area have documented a good efficacy of MAS3. In other words we think there is a decline in efficacy but we do not feel confident to say what the magnitude of this drop is. Changing policy is a difficult task and we need more and stronger evidence of the current efficacy of MAS3. The best design to avoid selection bias is to do an adequately powered randomized control trial and we would like to compare MAS3 with the next generation ACT: DP. We have already conducted studies with DP and we know it is safe and effective. In laboratory studies we found that this treatment (DP) is more effective against P.falciparum when it exhibits resistance to mefloquine via increased expression of the Pfmdr1 gene. We think it is timely to compare MAS3 and DP again and carefully monitor for the treatment response in patients with signs of mefloquine resistant parasites. Therefore, we propose a study to evaluate in an adequately powered RCT MAS3 (the current national policy for Thailand and routinely use along the border) to a potential replacement, DP.
Due to a lack of malaria patients at clinics, the trial was terminated. There will be no further analysis and or publication of the results.
- Conditions
- P. Falciparum Malaria
- Being tested
- Mefloquine+Artesunate, Dihydroartemisinin-Piperaquine
- Keywords
- Uncomplicated falciparum infection, Mefloquine-artesunate, Dihydroartemisinin-piperaquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mefloquine+ArtesunateDrug
Also called Eloquine®
One tablet of artesunate contains 40mg (Guilin Pharmaceutical Company, PRC). One tablet of mefloquine contains 250 mg mefloquine (Eloquine® (Medochemie Ltd., Cyprus) Standard three days regimen of artesunate-mefloquine given as 4mg/kg artesunate/day and 8 mg/kg of mefloquine/day on Days 0, 1 and 2
Dihydroartemisinin-PiperaquineDrug
Also called Duo-Cotecxin®
DHA-Piperaquine (Duo-Cotecxin® Beijing Holley-Cotec Pharmaceuticals Co., Ltd, China) One tablet contains 40mg of dihydroartemisinin and 320 mg piperaquine. A weight-based regimen containing 2.4 mg/kg DHA and 20 mg/kg PPQ once daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| DP | Experimental | 2.4 mg/kg dihydroartemisinin AND 20 mg/kg piperaquine once daily on Days 0, 1 and 2 Receives: Drug: Dihydroartemisinin-Piperaquine |
| MAS3 | Active comparator | 4mg/kg artesunate AND 8 mg/kg mefloquine once daily on Days 0, 1 and 2 Receives: Drug: Mefloquine+Artesunate |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR adjusted adequate clinical and parasitological response
Day 63 PCR adjusted adequate clinical and parasitological response (ACPR) in both DP3 arm and MAS3 arm
Measured: Day 63
Secondary outcomes (2)
PCR adjusted adequate clinical and parasitological response
Day 42 PCR adjusted adequate clinical and parasitological response (ACPR) in both DP3 arm and MAS3 arm
Measured: Day 42
Proportion of aparasitaemic
Proportion of aparasitaemic patients on day 3 in both DP3 arm and MAS3 arm
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study startNov 2013
- Primary completionMar 2017
- Study completion30 Mar 2017
Why it stopped: No adequate malaria patient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for P. Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Nosten, MD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01640587
- Sponsor's protocol ID
- SMRU1201
- Acronym
- RDM
- Status last verified
- Jun 2017
- First submitted
- 11 Jul 2012
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-label Trial of Comparison Between DHA-Piperaquine and Mefloquine Artesunate Combinations 3 Day-regimens for the Treatment of Uncomplicated Plasmodium Falciparum Malaria on the Thai-Myanmar Border (RDM)
- ClinicalTrials.gov ID
- NCT01640587
- Acronym / sponsor ID
- RDM / SMRU1201
- Conditions
- P. Falciparum Malaria
- Keywords
- Uncomplicated falciparum infection, Mefloquine-artesunate, Dihydroartemisinin-piperaquine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No adequate malaria patient
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 13 Jul 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.
In camps for displaced persons located along the Thai-Myanmar border, mefloquine and artesunate combination therapy has been used since 1992. In vivo efficacy of a 3 day regimen of mefloquine + artesunate (MAS3) has been monitored regularly since its introduction in 1992. In 2009 Carrara et al summarised the in vivo PCR-adjusted cure rates at Day 42 and Day 63 in patients treated with MAS3 between 1995 and 2005, as well as the in-vitro parasite susceptibility to MAS3 during that same period, and the changes in pfmdr1 copy numbers.The proportion of patients with parasitaemia persisting on day-2 increased significantly from 4.5% before 2001 to 21.9% after 2002 (p<0.001). Delayed parasite clearance was associated with increased risk of developing gametocytaemia (AOR = 2.29; 95% CI, 2.00-2.69, p = 0.002). MAS3 efficacy declined slightly but significantly (Hazards ratio 1.13; 95% CI, 1.07-1.19, p<0.001), although efficacy in 2007 remained well within acceptable limits: 96.5% (95% CI, 91.0-98.7). The proportion of infections caused by parasites with increased pfmdr1 copy number rose from 30% (12/40) in 1996 to 53% (24/45) in 2006 (p = 0.012, test for trend).
Evidence of reduced susceptibility to artemisinins in Western Cambodia was first reported in January 2007. Artemisinin resistance was manifest by a marked slowing of parasite clearance. A more recent analysis of parasite clearance data collected prospectively in patients with uncomplicated hyperparasitaemic malaria has shown a progressive decline in parasite clearance rates over the last decade suggesting a decline following the same trajectory as in Western Cambodia but with a time lag of a few years.
Surveillance data collected in 2011 have shown a dramatic and worrying decline in efficacy of MAS3, albeit in a small number of patients. This decline in efficacy of mefloquine + artesunate is likely to be attributable to reduced parasite susceptibility to mefloquine. The other fixed dose combinations available dihydroartemisinin-piperaquine (DP) is the best option to replace mefloquine-artesunate since it is thought that it remains effective in the presence of high pfmdr1 copy numbers. In addition DP is administered once daily and needs no special dietary modification to ensure adequate absorption.
In this study it is hypothesised that efficacy of DP (estimated to be 95%) will be significantly higher than that of MAS3 (estimated to be 65%), therefore the investigators propose to conduct a randomised controlled trial between DP and MAS3 for the treatment of P.falciparum.
Detailed description
In camps for displaced persons located along the Thai-Myanmar border, mefloquine and artesunate combination therapy has been used since 1992. It was studied first in trials, but by 1994 it became the first line treatment for all uncomplicated P. falciparum malaria episodes in the non-pregnant population. In vivo efficacy of a 3 day regimen of mefloquine+ artesunate (MAS3) has been monitored regularly since its introduction in 1992. In 2009 Carrara et al summarised the in vivo PCR-adjusted cure rates at Day 42 and Day 63 in patients treated with MAS3 between 1995 and 2005, as well as the in-vitro parasite susceptibility to MAS3 during that same period, and the changes in pfmdr1 copy numbers.The proportion of patients with parasitaemia persisting on day-2 increased significantly from 4.5% before 2001 to 21.9% after 2002 (p<0.001). Delayed parasite clearance was associated with increased risk of developing gametocytaemia (AOR = 2.29; 95% CI, 2.00-2.69, p = 0.002). MAS3 efficacy declined slightly but significantly (Hazards ratio 1.13; 95% CI, 1.07-1.19, p<0.001), although efficacy in 2007 remained well within acceptable limits: 96.5% (95% CI, 91.0-98.7). The proportion of infections caused by parasites with increased pfmdr1 copy number rose from 30% (12/40) in 1996 to 53% (24/45) in 2006 (p = 0.012, test for trend).
Evidence of reduced susceptibility to artemisinins in Western Cambodia was first reported in January 2007. Artemisinin resistance was manifest by a marked slowing of parasite clearance. In Pailin, Cambodia, the median parasite clearance time was 84 hours compared to 48 hours on the Thai side of the international border with Myanmar following either 2 mg/kg of artesunate (AS) alone for 7 days or 4 mg/kg AS for 3 days plus 25 mg/kg of mefloquine at both locations. A more recent analysis of parasite clearance data collected prospectively in patients with uncomplicated hyperparasitaemic malaria has shown a progressive decline in parasite clearance rates over the last decade suggesting a decline following the same trajectory as in Western Cambodia but with a time lag of a few years.
Clinic experience data collected in 2011 have shown a steady decline in efficacy of MAS3, albeit in a small number of patients. We have observed this trend over the past 10 years. It appears to be related to the increased copies of the gene Pfmdr1 in adult males. The PCR corrected efficacy in 43 patients was 47.0% (95% CI 27.0-64.7), well below the 90% threshold at which WHO recommends changing to an alternative treatment. This decline in efficacy of mefloquine + artesunate is likely to be attributable to reduced parasite susceptibility to mefloquine. The other fixed dose combinations available dihydroartemisinin-piperaquine (DP) is the best option to replace mefloquine-artesunate since it is thought that it remains effective in the presence of high pfmdr1 copy numbers. In addition DP is administered once daily and needs no special dietary modification to ensure adequate absorption.
However other groups in the area have documented a good efficacy of MAS3. In other words we think there is a decline in efficacy but we do not feel confident to say what the magnitude of this drop is. Changing policy is a difficult task and we need more and stronger evidence of the current efficacy of MAS3. The best design to avoid selection bias is to do an adequately powered randomized control trial and we would like to compare MAS3 with the next generation ACT: DP. We have already conducted studies with DP and we know it is safe and effective. In laboratory studies we found that this treatment (DP) is more effective against P.falciparum when it exhibits resistance to mefloquine via increased expression of the Pfmdr1 gene. We think it is timely to compare MAS3 and DP again and carefully monitor for the treatment response in patients with signs of mefloquine resistant parasites. Therefore, we propose a study to evaluate in an adequately powered RCT MAS3 (the current national policy for Thailand and routinely use along the border) to a potential replacement, DP.
Due to a lack of malaria patients at clinics, the trial was terminated. There will be no further analysis and or publication of the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DP | Experimental | Drug: Dihydroartemisinin-Piperaquine2.4 mg/kg dihydroartemisinin AND 20 mg/kg piperaquine once daily on Days 0, 1 and 2 |
| MAS3 | Active comparator | Drug: Mefloquine+Artesunate4mg/kg artesunate AND 8 mg/kg mefloquine once daily on Days 0, 1 and 2 |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 5 years
- Symptomatic of malaria infection, i.e. history of fever or presence of fever >37.5°c.
- microscopically confirmed asexual stages of Plasmodium falciparum ≥ 5/500 wbc (may be mixed with non- P.falciparum species) .
- Written informed consent given to participate in the trial.
- Participant or parent/guardian is willing and able to give informed consent for participation in the study.
Key exclusion criteria (12 listed)
- Pregnancy or lactation (urine test for β HCG to be performed on any woman of child bearing age unless menstruating).
- P.falciparum asexual stage parasitaemia greater than or equal to 4% red blood cells (175 000/µL).
- Signs or symptoms indicative of severe malaria:
- Patients who received any P. falciparum treatment within 2 months
- Known hypersensitivity to artemisinins - defined as history of erythroderma/ other severe cutaneous reaction, angioedema or anaphylaxis.
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: Eloquine®One tablet of artesunate contains 40mg (Guilin Pharmaceutical Company, PRC). One tablet of mefloquine contains 250 mg mefloquine (Eloquine® (Medochemie Ltd., Cyprus) Standard three days regimen of artesunate-mefloquine given as 4mg/kg artesunate/day and 8 mg/kg of mefloquine/day on Days 0, 1 and 2 | Drug | MAS3 |
| Dihydroartemisinin-PiperaquineAlso: Duo-Cotecxin®DHA-Piperaquine (Duo-Cotecxin® Beijing Holley-Cotec Pharmaceuticals Co., Ltd, China) One tablet contains 40mg of dihydroartemisinin and 320 mg piperaquine. A weight-based regimen containing 2.4 mg/kg DHA and 20 mg/kg PPQ once daily for 3 days | Drug | DP |
Primary outcome
PCR adjusted adequate clinical and parasitological response
Time frame: Day 63
Day 63 PCR adjusted adequate clinical and parasitological response (ACPR) in both DP3 arm and MAS3 arm
2 secondary outcomes
PCR adjusted adequate clinical and parasitological response
Time frame: Day 42
Proportion of aparasitaemic
Time frame: Day 3
Results and safety
The study was stopped early (reason given: No adequate malaria patient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
Related trials for P. Falciparum Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Not yet recruiting
Permethrin-Treated Baby Wraps for Malaria Prevention in Refugee Settings
Malaria (Plasmodium Falciparum), Malaria Incidence
RecruitingPhase 1/2
DON in Pediatric Cerebral Malaria
Malaria, Cerebral
Not yet recruitingPhase 1
Safety and Immunogenicity of the Recombinant Malaria Vaccines in Healthy Adults Aged 18-50 Years
Malaria Vaccine
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.
Francois Nosten, MD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mefloquine+Artesunate and Dihydroartemisinin-Piperaquine in people with P. Falciparum Malaria, run by University of Oxford 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 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 10 Jan 2023. 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 was stopped early (reason given: No adequate malaria patient). 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?
PCR adjusted adequate clinical and parasitological response (time frame: Day 63). 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 10 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.