Falciparum MalariaNCT00157833
A Randomized Trial of Coartemether and Artekin for the Treatment of Uncomplicated Malaria in Papua, Indonesia.
A study testing Artekin / Coartemther in people with Falciparum Malaria and Vivax Malaria, run by Menzies School of Health Research at 1 site in Indonesia.
Trial summary
This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (>10kg). Read more about this study
- Who is it for?
- Ages 12 months and older
- Conditions the study is for
- Falciparum Malaria, Vivax Malaria
- What is being tested?
- Artekin / Coartemther
- How many people
- 750 participants
- Where
- 1 siteIndonesia
- Study dates
- Jul 2004to Aug 2005
- 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 12 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male and female patients at least one 1year of age and weighing more than 10kg.
- Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
- Fever (axillary temperature >37.5C) or history of fever in the last 48 hours.
- Able to participate in the trial and comply with the clinical trial protocol
- Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent
Who cannot join
- Pregnancy or lactation
- Inability to tolerate oral treatment
- Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment (See Appendix II)
- Known hypersensitivity or allergy to artemisinin derivatives
- Serious underlying disease (cardiac, renal or hepatic)
- Parasitaemia >4%
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
SP9 and SP12 Malaria-Public Health Clinics
Timika, Special Region of Papua
About this study
Official title: A Randomized Trial to Determine the Efficacy and Safety of Coartemether and Artekin for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua
This open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (>10kg).
Read the detailed description
With the emergence of species of multi drug resistant P.falciparum across the archipelago the Indonesian Centre for Disease Control (CDC) now recommends amodiaquine plus artesunate in areas of high chloroquine and sulfadoxine-pyrimethamine resistant strains of P. falciparum. High levels of chloroquine resistance to P.vivax has also emerged in the eastern provinces.
This trial sets out to assess two fixed dose artemisinin combination regimens: artekin (DHA-Piperaquine) and coartemether (artemether-lumefantrine) against both P.falciparum and P. vivax and their safety profiles.
Patients who present to an established rural outpatient clinic in Timika, Papua with symptoms of acute, uncomplicated infection with P. falciparum, P.vivax or both species, will after laboratory confirmation of the diagnosis and having given informed consent to participate in the trial, be enrolled in the study. Drug administration will be supervised once per day. Patients will be treated as out-patients and then seen daily for the first week until aparasitaemic and thereafter at weekly visits to the clinic.
The data used from this trial will be used to make a public health decision to determine a suitable alternative first line antimalarial in the Timika region. In order to ensure that the data gathered will be relevant to the clinical setting in which the drugs will be used, drug administration of medication will be deliberately designed to mimic conditions that will be experienced with widespread deployment (eg once daily supervision).
- Conditions
- Falciparum Malaria, Vivax Malaria
- Being tested
- Artekin / Coartemther
- Keywords
- Coartemether, Artekin, Papua, Uncomplicated malaria
- Medical subject headings
- Malaria, Falciparum, Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artekin / CoartemtherDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Cure Rate at Day 42
Secondary outcomes (6)
Day 42 P.falciparum cure rate corrected for reinfection by PCR genotyping
Day 42 P.vivax cure rate
Overall day 28 cure rate for P.falciparum
Proportion of patients aparasitaemic on Days 1 and 2
Haematological recovery
Gametocyte Carriage during follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 750 participants
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, National Health and Medical Research Council, Australia, Wellcome Trust
- Investigators
- Ric N Price, Principal investigator, Menzies School of Health ResearchEmiliana Tjitra, Principal investigator, National Institute of Health Research and Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157833
- Sponsor's protocol ID
- TIMIKA_FC
- Status last verified
- Jun 2006
- First submitted
- 7 Sep 2005
- Last updated
- 26 Jun 2006
- Results posted
- No
Publications
Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, Laihad F, Ebsworth EP, Anstey NM, Tjitra E, Price RN. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet. 2007 Mar 3;369(9563):757-765. doi: 10.1016/S0140-6736(07)60160-3.
PubMed 17336652
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Determine the Efficacy and Safety of Coartemether and Artekin for the Treatment of Acute Falciparum and Vivax Malaria in Timika, Papua
- ClinicalTrials.gov ID
- NCT00157833
- Acronym / sponsor ID
- TIMIKA_FC
- Conditions
- Falciparum Malaria, Vivax Malaria
- Keywords
- Coartemether, Artekin, Papua, Uncomplicated malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Collaborators
- National Institute of Health Research and Development, Ministry of Health Republic of Indonesia, National Health and Medical Research Council, Australia, Wellcome Trust
- Study start
- Jul 2004
- Study completion
- Aug 2005
- First posted
- 12 Sep 2005 (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 open randomized, parallel group, 6 week trial in two rural outpatient clinics will compare the safety and efficacy of a six dose coartemether regimen with 3 dose artekin regimen for the treatment of acute, uncomplicated falciparum and vivax malaria in adults and children (>10kg).
Detailed description
With the emergence of species of multi drug resistant P.falciparum across the archipelago the Indonesian Centre for Disease Control (CDC) now recommends amodiaquine plus artesunate in areas of high chloroquine and sulfadoxine-pyrimethamine resistant strains of P. falciparum. High levels of chloroquine resistance to P.vivax has also emerged in the eastern provinces.
This trial sets out to assess two fixed dose artemisinin combination regimens: artekin (DHA-Piperaquine) and coartemether (artemether-lumefantrine) against both P.falciparum and P. vivax and their safety profiles.
Patients who present to an established rural outpatient clinic in Timika, Papua with symptoms of acute, uncomplicated infection with P. falciparum, P.vivax or both species, will after laboratory confirmation of the diagnosis and having given informed consent to participate in the trial, be enrolled in the study. Drug administration will be supervised once per day. Patients will be treated as out-patients and then seen daily for the first week until aparasitaemic and thereafter at weekly visits to the clinic.
The data used from this trial will be used to make a public health decision to determine a suitable alternative first line antimalarial in the Timika region. In order to ensure that the data gathered will be relevant to the clinical setting in which the drugs will be used, drug administration of medication will be deliberately designed to mimic conditions that will be experienced with widespread deployment (eg once daily supervision).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female patients at least one 1year of age and weighing more than 10kg.
- Microscopic confirmation of P. falciparum and /or P.vivax infection (any parasitaemia).
- Fever (axillary temperature >37.5C) or history of fever in the last 48 hours.
- Able to participate in the trial and comply with the clinical trial protocol
- Written informed consent to participate in trial; verbal consent in presence of literate witness is required for illiterate patients, and written consent from parents/guardian for children below age of consent
Key exclusion criteria (6 listed)
- Pregnancy or lactation
- Inability to tolerate oral treatment
- Signs/symptoms indicative of severe/complicated malaria or warning signs requiring parenteral treatment (See Appendix II)
- Known hypersensitivity or allergy to artemisinin derivatives
- Serious underlying disease (cardiac, renal or hepatic)
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 |
|---|---|---|
| Artekin / Coartemther | Drug | – |
Primary outcome
Overall Cure Rate at Day 42
6 secondary outcomes
Day 42 P.falciparum cure rate corrected for reinfection by PCR genotyping
Day 42 P.vivax cure rate
Overall day 28 cure rate for P.falciparum
Proportion of patients aparasitaemic on Days 1 and 2
Haematological recovery
Gametocyte Carriage during follow up
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 26 Jun 2006.
- Derived from this study: PubMed 17336652Ratcliff A, Siswantoro H, Kenangalem E, Maristela R, Wuwung RM, Laihad F, Ebsworth EP, Anstey NM, Tjitra E, Price RN. Two fixed-dose artemisinin combinations for drug-resistant falciparum and vivax malaria in Papua, Indonesia: an open-label randomised comparison. Lancet. 2007 Mar 3;369(9563):757-765. doi: 10.1016/S0140-6736(07)60160-3.
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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.
Ric N Price principal investigator
Menzies School of Health Research
Emiliana Tjitra principal investigator
National Institute of Health Research and Development
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artekin / Coartemther in people with Falciparum Malaria and Vivax Malaria, run by Menzies School of Health Research at 1 site in Indonesia.
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 6 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 26 Jun 2006. 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 Indonesia. 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?
Overall Cure Rate at Day 42. 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 NCT00157833, which also lists 1 linked publication.
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 26 Jun 2006.