Plasmodium Vivax MalariaPhase 4NCT01887821
Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam
A Phase 4 study testing Chloroquine and Dihydroartemisinin/Piperaquine in people with Plasmodium Vivax Malaria, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
Trial summary
This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax malaria, Chloroquine and Artemisinin. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Plasmodium Vivax Malaria
- What is being tested?
- Chloroquine and Dihydroartemisinin/Piperaquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteVietnam
- Study dates
- Feb 2013to Jun 2015
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age > 3 years;
- Mono-infection with P. vivax, parasitemia > 250/µl asexual forms for in vivo and >8000 asexual parasites/µl blood for in vitro testing;
- Presence of axillary or tympanic temperature ≥ 37.5 °C or history of fever during the past 24 h;
- Ability to swallow oral medication;
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
- Informed consent/assent
Who cannot join
- Presence of general danger signs or severe malaria according to the definitions of WHO (2000);
- Mixed infection with P.falciparum and P.vivax of other plasmodium species;
- Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- Regular medication, which may interfere with antimalarial pharmacokinetics;
- Received antimalarial drugs in the previous 48 hours;
- History of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
- Splenectomy;
- First trimester of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial to Assess the Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam
This is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for many years they become less effective at treating a disease, especially when they are not used at adequate doses according to national guidelines or when counterfeit drugs are available in the market. The purpose of this study is to check that Chloroquine and Artemisinin, are still effective for patients in Viet Nam.
Participants in this study will be treated with either Dihydroartemisinin-Piperaquine (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national guidelines to treat vivax malaria. The investigators would like to know if both of these treatments are equally effective so half of the patients in the study will be treated with DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare the drugs to find out if one is better than the other.
Read more
Participants will be followed for 3 days in hospital, then regularly by follow-up visits until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites in the participant's body and how the blood cells react to the malaria. The parasite will be tested to determine what type it is and how it reacts to the treatment.
The results of the study will be used to inform malaria treatment guidelines in Viet Nam.
- Conditions
- Plasmodium Vivax Malaria
- Being tested
- Chloroquine, Dihydroartemisinin/Piperaquine
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChloroquineDrug
Dihydroartemisinin/PiperaquineDrug
| Study group | Role | What they receive |
|---|---|---|
| Chloroquine | Active comparator | 25mg base/kg for 3 days Receives: Drug: Chloroquine |
| Dihydroartemisinin/Piperaquine | Active comparator | Dihydroartemisinin 40 mg + piperaquine phosphate 320 mg per tablet; once daily for three days, doses depend on weight Receives: Drug: Dihydroartemisinin/Piperaquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with adequate response to treatment
Adequate response = adequate clinical and parasitological response. Absence of parasitaemia on day 63, irrespective of temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.
Measured: Day 63
Secondary outcomes (6)
Proportion of patients classified as Early Treatment Failures
One or more of the following:
- danger signs or severe malaria on day 1, 2 or 3 in the presence of parasitaemia;
- parasitaemia on day 2 higher than on day 0, irrespective of temperature;
- parasitaemia on day 3 with temperature ≥ 37.5 ºC;
- parasitaemia on day 3 ≥ 25% of count on day 0.
Measured: Day 63
The parasite clearance time
Defined as the time in hours from the first treatment dose to the first of two consecutive parasitemia counts of zero.
Measured: Assessed every 6 hours until Day 3, or two consecutive parasite negative slides.
Fever clearance time
Defined as the time in hours from the first treatment dose to the start of the first sustained period of 24 hours without fever
Measured: Assessed every 6 hours until Day 3, or 24 hours without fever
Frequency of adverse and serious adverse events
Measured: Day 63
Proportion of patients classified as Late Clinical Failures
One or more of the following:
- danger signs or severe malaria in the presence of parasitaemia on any day between day 4 and day 63 in patients who did not previously meet any of the criteria of early treatment failure;
- presence of parasitaemia on any day between day 4 and day 63 with temperature ≥ 37.5 ºC (or history of fever) in patients who did not previously meet any of the criteria of early treatment failure
Measured: Day 63
Proportion of patients classified as Late Parasitological Failures
Presence of parasitaemia on any day between day 7 and day 63 with temperature < 37.5 ºC in patients who did not previously meet any of the criteria of early treatment failure or late clinical failure
Measured: Day 63
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Vivax 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Clinical Research Unit, Vietnam
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Malaria, Parasitology and Entomology, Ho Chi Minh City, Viet Nam, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Agency for Science, Technology and Research, Wellcome Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887821
- Sponsor's protocol ID
- 07MA
- Status last verified
- Jun 2014
- First submitted
- 19 Jun 2013
- Last updated
- 30 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Assess the Antimalarial Drug Susceptibility and Molecular Characterization of Plasmodium Vivax Isolates in Vietnam
- ClinicalTrials.gov ID
- NCT01887821
- Acronym / sponsor ID
- 07MA
- Conditions
- Plasmodium Vivax Malaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Oxford University Clinical Research Unit, VietnamUniversity, hospital or other
- Collaborators
- Institute of Malaria, Parasitology and Entomology, Ho Chi Minh City, Viet Nam, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam, Agency for Science, Technology and Research, Wellcome Trust
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Jun 2013 (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 is a study of drug effectiveness for 2 treatments of vivax malaria, which is one of the two main types of malaria in Viet Nam. There are two important drugs used in Viet Nam for treating vivax malaria, Chloroquine and Artemisinin. Sometimes, when medicines are used for many years they become less effective at treating a disease, especially when they are not used at adequate doses according to national guidelines or when counterfeit drugs are available in the market. The purpose of this study is to check that Chloroquine and Artemisinin, are still effective for patients in Viet Nam.
Participants in this study will be treated with either Dihydroartemisinin-Piperaquine (DHA-PPQ) or Chloroquine (CQ) for 3 days. Both drugs are recommended by the national guidelines to treat vivax malaria. The investigators would like to know if both of these treatments are equally effective so half of the patients in the study will be treated with DHA-PPQ and the other half will be treated with CQ. This way the investigators can compare the drugs to find out if one is better than the other.
Participants will be followed for 3 days in hospital, then regularly by follow-up visits until the 63rd day. Tests will be done to determine the amount of drug and malaria parasites in the participant's body and how the blood cells react to the malaria. The parasite will be tested to determine what type it is and how it reacts to the treatment.
The results of the study will be used to inform malaria treatment guidelines in Viet Nam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chloroquine | Active comparator | Drug: Chloroquine25mg base/kg for 3 days |
| Dihydroartemisinin/Piperaquine | Active comparator | Drug: Dihydroartemisinin/PiperaquineDihydroartemisinin 40 mg + piperaquine phosphate 320 mg per tablet; once daily for three days, doses depend on weight |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 3 years;
- Mono-infection with P. vivax, parasitemia > 250/µl asexual forms for in vivo and >8000 asexual parasites/µl blood for in vitro testing;
- Presence of axillary or tympanic temperature ≥ 37.5 °C or history of fever during the past 24 h;
- Ability to swallow oral medication;
- Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
Key exclusion criteria (8 listed)
- Presence of general danger signs or severe malaria according to the definitions of WHO (2000);
- Mixed infection with P.falciparum and P.vivax of other plasmodium species;
- Presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
- Regular medication, which may interfere with antimalarial pharmacokinetics;
- Received antimalarial drugs in the previous 48 hours;
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 |
|---|---|---|
| Chloroquine | Drug | Chloroquine |
| Dihydroartemisinin/Piperaquine | Drug | Dihydroartemisinin/Piperaquine |
Primary outcome
Proportion of patients with adequate response to treatment
Time frame: Day 63
Adequate response = adequate clinical and parasitological response. Absence of parasitaemia on day 63, irrespective of temperature, in patients who did not previously meet any of the criteria of early treatment failure, late clinical failure or late parasitological failure.
6 secondary outcomes
Proportion of patients classified as Early Treatment Failures
Time frame: Day 63
The parasite clearance time
Time frame: Assessed every 6 hours until Day 3, or two consecutive parasite negative slides.
Fever clearance time
Time frame: Assessed every 6 hours until Day 3, or 24 hours without fever
Frequency of adverse and serious adverse events
Time frame: Day 63
Proportion of patients classified as Late Clinical Failures
Time frame: Day 63
Proportion of patients classified as Late Parasitological Failures
Time frame: Day 63
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 30 Sep 2016.
- Oxford University Clinical Research Unit, Viet NamLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Chloroquine and Dihydroartemisinin/Piperaquine in people with Plasmodium Vivax Malaria, run by Oxford University Clinical Research Unit, Vietnam at 1 site in Vietnam.
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 8 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 30 Sep 2016. 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 Vietnam. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Proportion of patients with adequate response to treatment (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 30 Sep 2016.