Uncomplicated Falciparum MalariaPhase 3NCT00682578
A Comparative Study of Artekin With Standard Malarial Treatment Regimes in Afghanistan
A Phase 3 study testing Dihydroartemisinin + Piperaquine (Artekin) and artesunate-sulphadoxin/pyrimethamine, chloroquine in people with Uncomplicated Falciparum Malaria and Vivax Malaria, run by University of Oxford at 4 sites in Afghanistan.
Trial summary
Malaria is a major public health problem in many provinces of Afghanistan the failure rate of chloroquine (CQ) and amodiaquine (AQ) treated Plasmodium falciparum(Pf) malaria has risen to more than 60% overall and as high as 90% in Jalalabad. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- Uncomplicated Falciparum Malaria, Vivax Malaria
- What is being tested?
- Dihydroartemisinin + Piperaquine (Artekin) and artesunate-sulphadoxin/pyrimethamine, chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,086 participants
- Where
- 4 sitesAfghanistan
- Study dates
- Jul 2007to Feb 2010
- Phase
- Phase 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 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Uncomplicated falciparum or vivax malaria or mixed species infection, as confirmed in a peripheral blood slide.
- No signs of severe malaria
- Age over three months.
- Non-pregnant, (test for β-HCG in women of child-bearing age).
- Weight ≥5 kg
- Willingness to participate and written informed consent provided by the patient or in case of children by attending guardians/parents.
- Not enrolled in any other investigational drug study in the previous month
Who cannot join
- Clinical or laboratory features suggesting severe malaria.
- Known cardiac, renal, hepatic or other severe disease, or requirement for hospital treatment
- Recurrent vomiting.
- Not eligible for follow-up.
- Lactating mother
- Hyperparasitemia of P. falciparum > 100,000/µL
- Treatment with Artesunate or Chloroquine in the past one month, Fansidar in the past one and the half months and Artekin in past 3 months.
Trial locations and contacts
4 sites in 1 country.
Afghanistan4 sites
Provincial Malaria Control Centers (MRC)
Faryab
Provincial Malaria Control Centers (MRC)
Jalalabad
Provincial Malaria Control Centers (MRC)
Maymana
Provincial Malaria Control Centers (MRC)
Takhar
About this study
Official title: Randomized Clinical Trial of the Efficacy and Safety of Dihydroartimisinine+Papiraquine (Artekin) Compared With First Line Drugs for Treatment of Vivax and Uncomplicated Falciparum Malaria in Afghanistan
Malaria is a major public health problem in many provinces of Afghanistan the failure rate of chloroquine (CQ) and amodiaquine (AQ) treated Plasmodium falciparum(Pf) malaria has risen to more than 60% overall and as high as 90% in Jalalabad. CQ remains fully effective against P vivax, and sulphadoxine-pyrimethamine (SP) remains effective against P falciparum (10-15% of cases fail to cure). The current malaria treatment protocol still continuing CQ for P.vivax and adopted Artmisinine based combination therapy (ACT) for treating (Pf) malaria, as most than 50% malaria has being diagnosed clinically, so due to this and other operational reasons the protocol needs to be simplified.
By comparing 56 day PCR corrected cure rate of DHA-PPQ with the standard treatment regimen as primary objective and comparing the safety, gametocytecidal effect and parasite clearance time as secondary objectives, our study titled: Randomized, Open Label, controlled, non-inferiority clinical trial for comparison of Efficacy \& safety, will provide scientific evidence to lead the simplification and improvement of the standard malaria treatment regimen in Afghanistan; to adopt a policy of treating both vivax and falciparum malaria with the same drug regimen.
Read more
With a significance level (α) = 0.05 and a power=80%, the calculated sample size is 274 per study arm. Therefore about1100 patients (274 per study-arm: 548 patients with falciaprum malaria and 548 patients with vivax malaria) will be recruited in Malaria reference Centers (MRCs) of three malaria endemic provinces (Nangarhar in the east, Thakhar in the north-east and Faryab in the north-west of country) after signing written inform consent form, according the inclusion and exclusion criteria and will be treated as out patients by giving the randomized drug dose under observation of study team and followed-up daily for 3 days (as treatment course of either arm is once daily dose for three days) and after than weekly up to day 56. and the study is planed to conducted in 3 provinces of Afghanistan for approximately 2 years.
Patients will be assessed clinically as well necessary laboratory tests will be performed and all the bio-medical findings will be recorded in special patient case record form, the electronic form of which will be broth to Trop. Med of Mahidol University for final analysis. The patients will be receiving the reasonable transportation cost for follow-up visits as well as one bed-net at the end of enrollment.
- Conditions
- Uncomplicated Falciparum Malaria, Vivax Malaria
- Being tested
- Dihydroartemisinin + Piperaquine (Artekin), artesunate-sulphadoxin/pyrimethamine, chloroquine
- Keywords
- falciparum malaria, vivax malaria, dihydroartemisinin-piperaquine
- Medical subject headings
- Malaria, Vivax, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dihydroartemisinin + Piperaquine (Artekin)Drug
Also called Artekin
An adult dose consists of four doses of two tablets, given at 0, 8, 24 and 48 h. The approximate total adult dose is 6/48 mg/kg (DHA/PPQ). For children, a dose of 1.6/12.8 mg/kg is given at the same time intervals; this dosage will be obtained by dissolving the tablets in 5 ml of water.
artesunate-sulphadoxin/pyrimethamine, chloroquineDrug
The standard treatment will be in accordance with that in Afghanistan
| Study group | Role | What they receive |
|---|---|---|
| Artekin | Experimental | Dihydroartemisinin+ Paperaquine (DHA+PPQ, Artekin) Receives: Drug: Dihydroartemisinin + Piperaquine (Artekin) |
| Standard treatment | Active comparator | The standard treatment for uncomplicated falciparum and vivax malaria are as follows:
Uncomplicated falciparum: artesunate-sulphadoxin/pyrimethamine Vivax malaria: chloroquine Receives: Drug: artesunate-sulphadoxin/pyrimethamine, chloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR corrected adequate clinical and parasitological response (PCR corrected 'adequate clinical and parasitological response' or ACPR)
Measured: Day 56
Secondary outcomes (7)
Crude or PCR uncorrected ACPR
Measured: Day 56
Early treatment failure (failure to clear parasitaemia)
Measured: 7 days
fever clearance times
Measured: Days
parasite clearance times with no recrudescence over the observation period
Measured: days
gametocyte clearance times
Measured: weeks
Haemoglobin levels on day 14 compared to admission
Measured: day 14
safety and tolerability (rate and severity of adverse events)
Measured: day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startJul 2007
- Primary completionFeb 2010
- Study completionFeb 2010
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 Uncomplicated 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, Ministry of public Health Afghanistan
- Responsible party
- Sponsor
- Investigators
- Ghulam R Awab, MD, Principal investigator, Provincial Malaria Control Centers (MRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682578
- Sponsor's protocol ID
- BKMAL0701
- Status last verified
- May 2018
- First submitted
- 14 May 2008
- Last updated
- 9 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Awab GR, Imwong M, Pukrittayakamee S, Alim F, Hanpithakpong W, Tarning J, Dondorp AM, Day NP, White NJ, Woodrow CJ. Clinical trials of artesunate plus sulfadoxine-pyrimethamine for Plasmodium falciparum malaria in Afghanistan: maintained efficacy a decade after introduction. Malar J. 2016 Feb 25;15:121. doi: 10.1186/s12936-016-1167-z.
PubMed 26917051Awab GR, Pukrittayakamee S, Imwong M, Dondorp AM, Woodrow CJ, Lee SJ, Day NP, Singhasivanon P, White NJ, Kaker F. Dihydroartemisinin-piperaquine versus chloroquine to treat vivax malaria in Afghanistan: an open randomized, non-inferiority, trial. Malar J. 2010 Apr 21;9:105. doi: 10.1186/1475-2875-9-105.
PubMed 20409302
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
- Randomized Clinical Trial of the Efficacy and Safety of Dihydroartimisinine+Papiraquine (Artekin) Compared With First Line Drugs for Treatment of Vivax and Uncomplicated Falciparum Malaria in Afghanistan
- ClinicalTrials.gov ID
- NCT00682578
- Acronym / sponsor ID
- BKMAL0701
- Conditions
- Uncomplicated Falciparum Malaria, Vivax Malaria
- Keywords
- falciparum malaria, vivax malaria, dihydroartemisinin-piperaquine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,086 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Wellcome Trust, Ministry of public Health Afghanistan
- Study start
- Jul 2007 (actual)
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 22 May 2008 (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.
Malaria is a major public health problem in many provinces of Afghanistan the failure rate of chloroquine (CQ) and amodiaquine (AQ) treated Plasmodium falciparum(Pf) malaria has risen to more than 60% overall and as high as 90% in Jalalabad. CQ remains fully effective against P vivax, and sulphadoxine-pyrimethamine (SP) remains effective against P falciparum (10-15% of cases fail to cure). The current malaria treatment protocol still continuing CQ for P.vivax and adopted Artmisinine based combination therapy (ACT) for treating (Pf) malaria, as most than 50% malaria has being diagnosed clinically, so due to this and other operational reasons the protocol needs to be simplified.
By comparing 56 day PCR corrected cure rate of DHA-PPQ with the standard treatment regimen as primary objective and comparing the safety, gametocytecidal effect and parasite clearance time as secondary objectives, our study titled: Randomized, Open Label, controlled, non-inferiority clinical trial for comparison of Efficacy \& safety, will provide scientific evidence to lead the simplification and improvement of the standard malaria treatment regimen in Afghanistan; to adopt a policy of treating both vivax and falciparum malaria with the same drug regimen.
With a significance level (α) = 0.05 and a power=80%, the calculated sample size is 274 per study arm. Therefore about1100 patients (274 per study-arm: 548 patients with falciaprum malaria and 548 patients with vivax malaria) will be recruited in Malaria reference Centers (MRCs) of three malaria endemic provinces (Nangarhar in the east, Thakhar in the north-east and Faryab in the north-west of country) after signing written inform consent form, according the inclusion and exclusion criteria and will be treated as out patients by giving the randomized drug dose under observation of study team and followed-up daily for 3 days (as treatment course of either arm is once daily dose for three days) and after than weekly up to day 56. and the study is planed to conducted in 3 provinces of Afghanistan for approximately 2 years.
Patients will be assessed clinically as well necessary laboratory tests will be performed and all the bio-medical findings will be recorded in special patient case record form, the electronic form of which will be broth to Trop. Med of Mahidol University for final analysis. The patients will be receiving the reasonable transportation cost for follow-up visits as well as one bed-net at the end of enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artekin | Experimental | Drug: Dihydroartemisinin + Piperaquine (Artekin)Dihydroartemisinin+ Paperaquine (DHA+PPQ, Artekin) |
| Standard treatment | Active comparator | Drug: artesunate-sulphadoxin/pyrimethamine, chloroquineThe standard treatment for uncomplicated falciparum and vivax malaria are as follows: Uncomplicated falciparum: artesunate-sulphadoxin/pyrimethamine Vivax malaria: chloroquine |
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Uncomplicated falciparum or vivax malaria or mixed species infection, as confirmed in a peripheral blood slide.
- No signs of severe malaria
- Age over three months.
- Non-pregnant, (test for β-HCG in women of child-bearing age).
- Weight ≥5 kg
Key exclusion criteria (7 listed)
- Clinical or laboratory features suggesting severe malaria.
- Known cardiac, renal, hepatic or other severe disease, or requirement for hospital treatment
- Recurrent vomiting.
- Not eligible for follow-up.
- Lactating mother
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 |
|---|---|---|
| Dihydroartemisinin + Piperaquine (Artekin)Also: ArtekinAn adult dose consists of four doses of two tablets, given at 0, 8, 24 and 48 h. The approximate total adult dose is 6/48 mg/kg (DHA/PPQ). For children, a dose of 1.6/12.8 mg/kg is given at the same time intervals; this dosage will be obtained by dissolving the tablets in 5 ml of water. | Drug | Artekin |
| artesunate-sulphadoxin/pyrimethamine, chloroquineThe standard treatment will be in accordance with that in Afghanistan | Drug | Standard treatment |
Primary outcome
PCR corrected adequate clinical and parasitological response (PCR corrected 'adequate clinical and parasitological response' or ACPR)
Time frame: Day 56
7 secondary outcomes
Crude or PCR uncorrected ACPR
Time frame: Day 56
Early treatment failure (failure to clear parasitaemia)
Time frame: 7 days
fever clearance times
Time frame: Days
parasite clearance times with no recrudescence over the observation period
Time frame: days
gametocyte clearance times
Time frame: weeks
Haemoglobin levels on day 14 compared to admission
Time frame: day 14
safety and tolerability (rate and severity of adverse events)
Time frame: day 56
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 26917051Awab GR, Imwong M, Pukrittayakamee S, Alim F, Hanpithakpong W, Tarning J, Dondorp AM, Day NP, White NJ, Woodrow CJ. Clinical trials of artesunate plus sulfadoxine-pyrimethamine for Plasmodium falciparum malaria in Afghanistan: maintained efficacy a decade after introduction. Malar J. 2016 Feb 25;15:121. doi: 10.1186/s12936-016-1167-z.
- Derived from this study: PubMed 20409302Awab GR, Pukrittayakamee S, Imwong M, Dondorp AM, Woodrow CJ, Lee SJ, Day NP, Singhasivanon P, White NJ, Kaker F. Dihydroartemisinin-piperaquine versus chloroquine to treat vivax malaria in Afghanistan: an open randomized, non-inferiority, trial. Malar J. 2010 Apr 21;9:105. doi: 10.1186/1475-2875-9-105.
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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.
Ghulam R Awab, MD principal investigator
Provincial Malaria Control Centers (MRC)
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dihydroartemisinin + Piperaquine (Artekin) and artesunate-sulphadoxin/pyrimethamine, chloroquine in people with Uncomplicated Falciparum Malaria and Vivax Malaria, run by University of Oxford at 4 sites in Afghanistan.
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 7 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 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 4 sites in Afghanistan. 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 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 adequate clinical and parasitological response (PCR corrected 'adequate clinical and parasitological response' or ACPR) (time frame: Day 56). 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 NCT00682578, 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.