Malaria, FalciparumPhase 2/3TRACIINCT02453308
A Study by the Tracking Resistance to Artemisinin Collaboration (TRAC)
A Phase 2/3 study testing ACT and TACT in people with Malaria, Falciparum, run by University of Oxford at 20 sites in 8 countries.
Trial summary
This study is an open-label randomised trial comparing standard ACT treatment with matching triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1 site in Africa. Read more about this study
- Who is it for?
- Ages 6 months to 65 years
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- ACT and TACT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,110 participants
- Where
- 20 sitesin 8 countries
- Study dates
- Aug 2015to Mar 2018
- Phase
- Phase 2/3
- 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 6 months to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, aged from 6 months to 65 years old
- Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum (or mixed with non-falciparum species)
- Asexual P. falciparum parasitaemia: 5,000 to 200,000/uL, de-termined on a thin or thick blood film (In Cambodia patients with a parasitaemia of 16 to 200,000/uL are eligible. In DRC patients with a parasitaemia of 10,000 to 250,000/ul are eligi-ble)
- Fever defined as >/= 37.5°C tympanic temperature or a history of fever within the last 24 hours
- Written informed consent (by parent/guardian in case of children)
- Willingness and ability of the patients or parents/guardians to comply with the study protocol for the duration of the study
Who cannot join
- Signs of severe/complicated malaria
- Haematocrit < 25% or Hb < 5 g/dL at screening (DRC: Hct<15% and Hb <5 g/dL due to high prevalence of anemia).
- Acute illness other than malaria requiring treatment
- For females: pregnancy, breast feeding
- Patients who have received artemisinin or a derivative or an artemisinin containing combination therapy (ACT) within the previous 7 days
- Treatment with mefloquine in the 2 months prior to presentation will be an exclusion criteria in the DHA-P+MQ sites
Show all 11Show fewer
- History of allergy or known contraindication to artemisinins, or to the ACT or TACT to be used at the site e.g. neuropsychiatric disorders will be a contraindication for the use of mefloquine.
- Previous splenectomy
- QTc-interval > 450 milliseconds at moment of presentation
- Documented or claimed history of cardiac conduction problems
- Earlier participation within the TRACII trial or another trial in the previous 3 months.
Trial locations and contacts
20 sites in 8 countries.
20 sites in 8 countries
Thailand5 sites
Chumphon hospital
Chumphon
Phusing hospital
Phusing, Changwat Si Sa Ket
Kunhan Hospital
Si Sa Ket
Tha Song Yang hospital
Tha Song Yang, Changwat Tak
Thanto Hospital
Yala
Burma4 sites
Ann Hospital
Ann Town
Pyay hospital
Prome
Pyin oo Lwin hospital
Pyin Oo Lwin
Thabeikkyin hospital
Thabeikkyin
Cambodia4 sites
Pailin
Pailin
Preah Vihear
Preah Vihear
Pursat
Pursat
Ratanakiri
Ratankiri
India3 sites
Mohanpur Community health center
Agartala
Midnapore
Medinīpur
Ispat General hospital
Rourkela, Rourkela
Democratic Republic of the Congo1 site
Kinshasa
Kinshasa
About this study
Official title: A Multi-centre, Open-label Randomised Trial to Assess the Efficacy, Safety and Tolerability of Triple Artemisinin-based Combination Therapies (TACTs) Com-pared to Artemisinin-based Combination Therapies (ACTs) in Uncomplicated Falciparum Malaria and to Map the Geographical Spread of Artemisinin and Partner Drug Resistance
This study is an open-label randomised trial comparing standard ACT treatment with matching triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1 site in Africa. There are 2 arm study groups that have 2 treatment arms each.
Study group A:
Read more
A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days.
Study group B:
B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
Study group C:
C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
According to the WHO guideline, all patients except for children under the age of 1 year or a weight below 10 kilograms will also be treated with a single dose of low dose primaquine.
Read the detailed description
In Laos, Myanmar, Bangladesh, India and DRC, the following two combinations will be used:
- Artemether-lumefantrine combined with amodiaquine (TACT arm) or
- Artemether-lumefantrine (ACT arm)
In Myanmar and Vietnam the following two combinations will be used:
- Dihydroartemisinin-piperaquine combined with mefloquine (TACT arm) or
- Dihydroartemisinin-piperaquine (ACT arm)
In Cambodia and Thailand the following two combinations will be used:
- Dihydroartemisinin-piperaquine plus Mefloquine hydrochloride (TACT arm) or
- Artesunate-mefloquine (ACT arm)
- Conditions
- Malaria, Falciparum
- Being tested
- ACT, TACT
- Keywords
- Artemisinin combination Therapies
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACTDrug
- Artemether-lumefantrine for 3 days
- Dihydroartemisinin-piperaquine for 3 days.
- Artesunate-mefloquine for 3 days
TACTDrug
- Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days.
- Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
- Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
| Study group | Role | What they receive |
|---|---|---|
| ACT-arms | Active comparator | 1.1 Artemether-lumefantrine for 3 days.
1.2 Dihydroartemisinin-piperaquine for 3 days
1.3 Artesunate-Mefloquine for 3 days Receives: Drug: ACT |
| TACT-arms | Active comparator | 2.1: Artemether-lumefantrine for 3 days.plus: Amodiaquine for 3 days.
2.2: Dihydroartemisinin-piperaquine for 3 days. plus: Mefloquine hydrochloride for 3 days.
2.3 Dihydroartemisinin-piperaquine for 3 days. plus: Mefloquine hydrochloride for 3 days. Receives: Drug: TACT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR corrected efficacy defined as adequate clinical and parasitological response (ACPR)
Measured: 42 days
Secondary outcomes (23)
Parasite clearance half-life
Parasite clearance half-life assessed by microscopy as primary parameter to de-termine parasite clearance
Measured: 42 days
Parasite reduction rates and ratios at 24 and 48 hours assessed by microscopy
Measured: at 24 and 48 hours
Time for parasite count to fall to 50% of initial parasite density
Measured: 42 days
Time for parasite count to fall to 90% of initial parasite density
Measured: 42 days
Time for parasite count to fall to 99% of initial parasite density
Measured: 42 days
Fever clearance time
Measured: 42 days
Incidence of adverse events and serious adverse events
Measured: 42 days
Incidence of adverse events concerning markers of hepatic toxicity
Total billirubin, ALT, AST and Alkaline Phosphatase will be measured
Measured: 42 days
Incidence of adverse events concerning markersof renal toxicity
Creatinine will be measured
Measured: 42 days
Incidence of prolongation of the QTc-interval
Incidence of prolongation of the Qtc-interval above 500 ms or > 60ms above baseline values
Measured: 3 days
Change in hemoglobin/hematocrit
Change in hemoglobin/hematocrit on day 1 to 7, 14, 21, 28, 35 and 42 according to geographical location and study arm, stratified for G6PD status
Measured: 42 days
Proportion of patients that reports completing a full course of observed TACT or ACT without withdrawal of consent or exclusion from study
Measured: 42 days
Prevalence of Kelch13 mutations of known functional significance
Measured: 42 days
Prevalence/incidence of other genetic markers of antimalarial drug resistance
Measured: 42 days
Genome wide association with in vivo/in vitro sensitivity parasite phenotype
Measured: 42 days
Correlation between SNPs measured in dry blood spots and whole genome sequencing in leukocyte depleted blood samples
Measured: 42 days
Transcriptomic patterns at t=0 and t=6h comparing sensitive and resistant parasites
Measured: 6hrs after start of treatment
Correlation between qPCR based versus microscopy based assessments of parasite clearance dynamics
Measured: 14 days
Proportion of patients with gametocytemia before,after treatment with Primaquine
Measured: assessed at admission, up to day 14
Levels of RNA transcription coding for male or female specific gametocytes
Measured: at admission up to day 14
In vitro sensitivity (expressed in IC50 values among others) of P. falciparum to artemisinins and partner drugs
Measured: 42 days
• Pharmacokinetic profiles and interactions of artemisinin-derivatives and partner drugs (half-life, Cmax, AUC, Tmax) in 20 ACT treated and 20 TACT treated patients of both study arms
Measured: 42 days
Day 7 drug levels of partner drugs in association with treatment efficacy and treatment arm
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malaria, FalciparumStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arjen Dondorp, MD, Principal investigator, Mahidol Oxford Tropical Medicine Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453308
- Sponsor's protocol ID
- BAKMAL1502
- Acronym
- TRACII
- Status last verified
- May 2018
- First submitted
- 20 Apr 2015
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Pluijm RW, Tripura R, Hoglund RM, Pyae Phyo A, Lek D, Ul Islam A, Anvikar AR, Satpathi P, Satpathi S, Behera PK, Tripura A, Baidya S, Onyamboko M, Chau NH, Sovann Y, Suon S, Sreng S, Mao S, Oun S, Yen S, Amaratunga C, Chutasmit K, Saelow C, Runcharern R, Kaewmok W, Hoa NT, Thanh NV, Hanboonkunupakarn B, Callery JJ, Mohanty AK, Heaton J, Thant M, Gantait K, Ghosh T, Amato R, Pearson RD, Jacob CG, Goncalves S, Mukaka M, Waithira N, Woodrow CJ, Grobusch MP, van Vugt M, Fairhurst RM, Cheah PY, Peto TJ, von Seidlein L, Dhorda M, Maude RJ, Winterberg M, Thuy-Nhien NT, Kwiatkowski DP, Imwong M, Jittamala P, Lin K, Hlaing TM, Chotivanich K, Huy R, Fanello C, Ashley E, Mayxay M, Newton PN, Hien TT, Valecha N, Smithuis F, Pukrittayakamee S, Faiz A, Miotto O, Tarning J, Day NPJ, White NJ, Dondorp AM; Tracking Resistance to Artemisinin Collaboration. Triple artemisinin-based combination therapies versus artemisinin-based combination therapies for uncomplicated Plasmodium falciparum malaria: a multicentre, open-label, randomised clinical trial. Lancet. 2020 Apr 25;395(10233):1345-1360. doi: 10.1016/S0140-6736(20)30552-3. Epub 2020 Mar 11.
PubMed 32171078van der Pluijm RW, Imwong M, Chau NH, Hoa NT, Thuy-Nhien NT, Thanh NV, Jittamala P, Hanboonkunupakarn B, Chutasmit K, Saelow C, Runjarern R, Kaewmok W, Tripura R, Peto TJ, Yok S, Suon S, Sreng S, Mao S, Oun S, Yen S, Amaratunga C, Lek D, Huy R, Dhorda M, Chotivanich K, Ashley EA, Mukaka M, Waithira N, Cheah PY, Maude RJ, Amato R, Pearson RD, Goncalves S, Jacob CG, Hamilton WL, Fairhurst RM, Tarning J, Winterberg M, Kwiatkowski DP, Pukrittayakamee S, Hien TT, Day NP, Miotto O, White NJ, Dondorp AM. Determinants of dihydroartemisinin-piperaquine treatment failure in Plasmodium falciparum malaria in Cambodia, Thailand, and Vietnam: a prospective clinical, pharmacological, and genetic study. Lancet Infect Dis. 2019 Sep;19(9):952-961. doi: 10.1016/S1473-3099(19)30391-3. Epub 2019 Jul 22.
PubMed 31345710
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Open-label Randomised Trial to Assess the Efficacy, Safety and Tolerability of Triple Artemisinin-based Combination Therapies (TACTs) Com-pared to Artemisinin-based Combination Therapies (ACTs) in Uncomplicated Falciparum Malaria and to Map the Geographical Spread of Artemisinin and Partner Drug Resistance
- ClinicalTrials.gov ID
- NCT02453308
- Acronym / sponsor ID
- TRACII / BAKMAL1502
- Conditions
- Malaria, Falciparum
- Keywords
- Artemisinin combination Therapies
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,110 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 25 May 2015 (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.
This study is an open-label randomised trial comparing standard ACT treatment with matching triple artemisinin-based combination therapies (TACTs), evaluating efficacy in safety and tolerability. The estimated total sample size is 2040 patients from 16 sites in Asia and 1 site in Africa. There are 2 arm study groups that have 2 treatment arms each.
Study group A:
A.1: Artemether-lumefantrine for 3 days. versus: A.2: Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days.
Study group B:
B.1: Dihydroartemisinin-piperaquine for 3 days. versus: B.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
Study group C:
C.1: Artesunate-mefloquine for 3 days versus: C.2: Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
According to the WHO guideline, all patients except for children under the age of 1 year or a weight below 10 kilograms will also be treated with a single dose of low dose primaquine.
Detailed description
In Laos, Myanmar, Bangladesh, India and DRC, the following two combinations will be used:
- Artemether-lumefantrine combined with amodiaquine (TACT arm) or
- Artemether-lumefantrine (ACT arm)
In Myanmar and Vietnam the following two combinations will be used:
- Dihydroartemisinin-piperaquine combined with mefloquine (TACT arm) or
- Dihydroartemisinin-piperaquine (ACT arm)
In Cambodia and Thailand the following two combinations will be used:
- Dihydroartemisinin-piperaquine plus Mefloquine hydrochloride (TACT arm) or
- Artesunate-mefloquine (ACT arm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-arms | Active comparator | Drug: ACT1.1 Artemether-lumefantrine for 3 days. 1.2 Dihydroartemisinin-piperaquine for 3 days 1.3 Artesunate-Mefloquine for 3 days |
| TACT-arms | Active comparator | Drug: TACT2.1: Artemether-lumefantrine for 3 days.plus: Amodiaquine for 3 days. 2.2: Dihydroartemisinin-piperaquine for 3 days. plus: Mefloquine hydrochloride for 3 days. 2.3 Dihydroartemisinin-piperaquine for 3 days. plus: Mefloquine hydrochloride for 3 days. |
Who may qualify
- Ages
- 6 months to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, aged from 6 months to 65 years old
- Acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of P. falciparum (or mixed with non-falciparum species)
- Asexual P. falciparum parasitaemia: 5,000 to 200,000/uL, de-termined on a thin or thick blood film (In Cambodia patients with a parasitaemia of 16 to 200,000/uL are eligible. In DRC patients with a parasitaemia of 10,000 to 250,000/ul are eligi-ble)
- Fever defined as >/= 37.5°C tympanic temperature or a history of fever within the last 24 hours
- Written informed consent (by parent/guardian in case of children)
Key exclusion criteria (11 listed)
- Signs of severe/complicated malaria
- Haematocrit < 25% or Hb < 5 g/dL at screening (DRC: Hct<15% and Hb <5 g/dL due to high prevalence of anemia).
- Acute illness other than malaria requiring treatment
- For females: pregnancy, breast feeding
- Patients who have received artemisinin or a derivative or an artemisinin containing combination therapy (ACT) within the previous 7 days
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 |
|---|---|---|
| ACT1. Artemether-lumefantrine for 3 days 2. Dihydroartemisinin-piperaquine for 3 days. 3. Artesunate-mefloquine for 3 days | Drug | ACT-arms |
| TACT1. Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days. 2. Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days. 3. Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days. | Drug | TACT-arms |
Primary outcome
PCR corrected efficacy defined as adequate clinical and parasitological response (ACPR)
Time frame: 42 days
23 secondary outcomes
Parasite clearance half-life
Time frame: 42 days
Parasite reduction rates and ratios at 24 and 48 hours assessed by microscopy
Time frame: at 24 and 48 hours
Time for parasite count to fall to 50% of initial parasite density
Time frame: 42 days
Time for parasite count to fall to 90% of initial parasite density
Time frame: 42 days
Time for parasite count to fall to 99% of initial parasite density
Time frame: 42 days
Fever clearance time
Time frame: 42 days
Incidence of adverse events and serious adverse events
Time frame: 42 days
Incidence of adverse events concerning markers of hepatic toxicity
Time frame: 42 days
Incidence of adverse events concerning markersof renal toxicity
Time frame: 42 days
Incidence of prolongation of the QTc-interval
Time frame: 3 days
Change in hemoglobin/hematocrit
Time frame: 42 days
Proportion of patients that reports completing a full course of observed TACT or ACT without withdrawal of consent or exclusion from study
Time frame: 42 days
Prevalence of Kelch13 mutations of known functional significance
Time frame: 42 days
Prevalence/incidence of other genetic markers of antimalarial drug resistance
Time frame: 42 days
Genome wide association with in vivo/in vitro sensitivity parasite phenotype
Time frame: 42 days
Correlation between SNPs measured in dry blood spots and whole genome sequencing in leukocyte depleted blood samples
Time frame: 42 days
Transcriptomic patterns at t=0 and t=6h comparing sensitive and resistant parasites
Time frame: 6hrs after start of treatment
Correlation between qPCR based versus microscopy based assessments of parasite clearance dynamics
Time frame: 14 days
Proportion of patients with gametocytemia before,after treatment with Primaquine
Time frame: assessed at admission, up to day 14
Levels of RNA transcription coding for male or female specific gametocytes
Time frame: at admission up to day 14
In vitro sensitivity (expressed in IC50 values among others) of P. falciparum to artemisinins and partner drugs
Time frame: 42 days
• Pharmacokinetic profiles and interactions of artemisinin-derivatives and partner drugs (half-life, Cmax, AUC, Tmax) in 20 ACT treated and 20 TACT treated patients of both study arms
Time frame: 42 days
Day 7 drug levels of partner drugs in association with treatment efficacy and treatment arm
Time frame: Day 7
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 9 May 2018.
- Derived from this study: PubMed 32171078van der Pluijm RW, Tripura R, Hoglund RM, Pyae Phyo A, Lek D, Ul Islam A, Anvikar AR, Satpathi P, Satpathi S, Behera PK, Tripura A, Baidya S, Onyamboko M, Chau NH, Sovann Y, Suon S, Sreng S, Mao S, Oun S, Yen S, Amaratunga C, Chutasmit K, Saelow C, Runcharern R, Kaewmok W, Hoa NT, Thanh NV, Hanboonkunupakarn B, Callery JJ, Mohanty AK, Heaton J, Thant M, Gantait K, Ghosh T, Amato R, Pearson RD, Jacob CG, Goncalves S, Mukaka M, Waithira N, Woodrow CJ, Grobusch MP, van Vugt M, Fairhurst RM, Cheah PY, Peto TJ, von Seidlein L, Dhorda M, Maude RJ, Winterberg M, Thuy-Nhien NT, Kwiatkowski DP, Imwong M, Jittamala P, Lin K, Hlaing TM, Chotivanich K, Huy R, Fanello C, Ashley E, Mayxay M, Newton PN, Hien TT, Valecha N, Smithuis F, Pukrittayakamee S, Faiz A, Miotto O, Tarning J, Day NPJ, White NJ, Dondorp AM; Tracking Resistance to Artemisinin Collaboration. Triple artemisinin-based combination therapies versus artemisinin-based combination therapies for uncomplicated Plasmodium falciparum malaria: a multicentre, open-label, randomised clinical trial. Lancet. 2020 Apr 25;395(10233):1345-1360. doi: 10.1016/S0140-6736(20)30552-3. Epub 2020 Mar 11.
- Derived from this study: PubMed 31345710van der Pluijm RW, Imwong M, Chau NH, Hoa NT, Thuy-Nhien NT, Thanh NV, Jittamala P, Hanboonkunupakarn B, Chutasmit K, Saelow C, Runjarern R, Kaewmok W, Tripura R, Peto TJ, Yok S, Suon S, Sreng S, Mao S, Oun S, Yen S, Amaratunga C, Lek D, Huy R, Dhorda M, Chotivanich K, Ashley EA, Mukaka M, Waithira N, Cheah PY, Maude RJ, Amato R, Pearson RD, Goncalves S, Jacob CG, Hamilton WL, Fairhurst RM, Tarning J, Winterberg M, Kwiatkowski DP, Pukrittayakamee S, Hien TT, Day NP, Miotto O, White NJ, Dondorp AM. Determinants of dihydroartemisinin-piperaquine treatment failure in Plasmodium falciparum malaria in Cambodia, Thailand, and Vietnam: a prospective clinical, pharmacological, and genetic study. Lancet Infect Dis. 2019 Sep;19(9):952-961. doi: 10.1016/S1473-3099(19)30391-3. Epub 2019 Jul 22.
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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.
Arjen Dondorp, MD principal investigator
Mahidol Oxford Tropical Medicine Research Unit
20 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ACT and TACT in people with Malaria, Falciparum, run by University of Oxford at 20 sites in 8 countries.
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 11 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 9 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Thailand, Burma, Cambodia, India, Bangladesh and 3 more countries. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
PCR corrected efficacy defined as adequate clinical and parasitological response (ACPR) (time frame: 42 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453308, which also lists 2 linked publications.
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 9 May 2018; AzTrials last refreshed its copy on 26 Oct 2026.